Abstract of thesis entitled An Evidence-based Parent ... Yuk Pui.pdf · Childhood Immunization” Submitted by Lam Yuk Pui For the degree of Master of Nursing ... 4.2 Pilot Study

1

Abstract of thesis entitled

“An Evidence-based Parent-directed Education Program in Increasing

Knowledge and Utilization of Pain Management During

Childhood Immunization”

Submitted by

Lam Yuk Pui

For the degree of Master of Nursing

at The University of Hong Kong

in July 2016

Immunization is one of the most effective ways in preventing infectious diseases.

However, the immunization-induced pain lead to distress in children, parents and health

care providers. Through scientifically proven pain management are available, they are

seldom used by parents. Therefore, it is essential to develop an evidence-based

guideline for increasing parents’ knowledge and utilization of the scientifically proven

pain management during childhood immunization.

The objectives of this study are to systematically review the current literatures on the

effectiveness of education program in increasing knowledge and utilization of pain

management of parents of the children under six years old. Data from the selected

studies are extracted for establishing table of evidence. Moreover, quality assessment

2

of the selected articles is performed. An evidence-based guideline of parent-directed

education program is developed and its feasibility and transferability to the target

setting and clients is determined.

In this study, parent-directed education program is proposed. The target setting is one

of the Maternal and Child Health Centres in Hong Kong and the target clients are

parents of children under six years old. Data are extracted from 5 articles. The

implementation potential of the proposed guideline is high because of its transferability,

feasibility and cost-effectiveness. Based on the evidence, an evidence-based practice

guideline is developed to increase the knowledge and use of scientifically proven pain

management by parents. In order to improve the quality of life of both children and

parents and the quality of the service, it is recommended to establish the practice to all

Maternal and Child Health Centres.

3

An Evidence-based Parent-directed Education Program in Increasing

Knowledge and Utilization of Pain Management During

Childhood Immunization

by

Lam Yuk Pui

BSc(Hons) NURS, R.N.

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July 2016

i

Declaration

I declare that this thesis thereof represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a degree,

diploma or other qualifications.

Signed

Lam Yuk Pui

ii

Acknowledgements

I would like to express my sincere gratitude to my supervisor, Dr. Athena Hong

Wai Lin, for her guidance and advice on my thesis. Besides, I cannot forget my dear

groupmates who accompanied me with great support in the process.

In addition, I offer my heartfelt blessings to my family, especially my beloved

husband, for their sincere support, selfless love and understanding which assist me in

passing through the obstacles throughout the period of my study. I would like to share

the honour with them.

At last, I would like to take this opportunity to thank Department of Health for

offering me the sponsorship to accomplish the Master Degree in The University of

Hong Kong.

iii

Table of Contents

Declaration i

Acknowledgement ii

Table of Contents iii

List of Appendices v

Abbreviations vi

Chapter 1: Introduction 1

1.1 Background 1

1.2 Affirming the Needs 2

1.3 Objectives and Significance 4

1.3.1 Objectives 4

1.3.2 PICO components 5

1.3.3 Significance 5

Chapter 2: Critical Appraisal 6

2.1 Search and Appraisal Strategies 6

2.1.1 Electronic databases and keywords for searching 6

2.1.2 Selection criteria 7

2.1.3 Appraisal strategies 8

2.2 Results 8

2.2.1 Report of the search results 8

2.2.2 Summary of the data extracted 9

2.2.3 Summary of the appraisal results 11

2.3 Summary and Synthesis 14

2.3.1 Summary of data 14

2.3.2 Synthesis 16

2.3.3 Implication for practice 18

Chapter 3: Implementation Potential and Clinical Guideline 19

3.1 Transferability 19

3.1.1 Target setting 19

3.1.2 Target audience 20

3.1.3 Similarity of the setting between the identified studies and the

target setting

20

3.1.4 Philosophy of care 21

3.1.5 Similarity of characteristic of population between the identified

studies and the target setting

22

3.1.6 Number of clients benefited from the innovation 22

3.1.7 Length of time for implementation and evaluation 22

3.2 Feasibility 23

3.2.1 Organizational climate and administrative support 23

3.2.2 Consensus and friction among nurses 24

3.2.3 Interference to current practice 24

iv

3.2.4 Availability of resources and equipment 25

3.2.5 Evaluation tool 26

3.3 Cost-Benefit Ratio 27

3.3.1 Potential risk of the innovation 27

3.3.2 Potential benefits resulted from the innovation 27

3.3.3 Risk and cost of maintaining current practice 28

3.3.4 Cost of the innovation 29

3.3.5 Cost of not implementing the innovation 29

3.4 Evidence-Based Practice Guideline 30

Chapter 4: Implementation Plan 31

4.1 Communication Plan 31

4.1.1 The stakeholders 31

4.1.2 The process of communication 32

4.2 Pilot Study Plan 34

4.3 Evaluation Plan 36

4.3.1 Outcomes to be achieved 36

4.3.2 Nature and number of clients involved 38

4.3.3 Time to take measurement 39

4.3.4 Data analysis 39

4.4 Basis for Implementation 40

Chapter 5: Conclusion 42

Appendices 44

Reference 66

v

List of Appendices

A. Hong Kong Childhood Immunization Programme 44

B. Levels of Evidence 45

C. PRISMA 2009 Flow Diagram 46

D. Table of Evidence 47

E. Checklist of SIGN 49

F. Time Schedule for Implementation Process of the Innovation 54

G. Content of the Pamphlet and Video 55

H. Cost of the Innovation 56

I. Cost of Not implementing the Innovation 57

J. Grades of Recommendations 58

K. Evidence-based Practice Guideline 59

L. Knowledge Test 62

M. Observation Form of Parental use of Scientifically Proven Pain

Management during childhood immunization

63

N. Self-developed Satisfactory Questionnaire 64

O. Outline of the Semi-structured Meeting 65

vi

Abbreviations

Chief Nursing Officer (CNO)

Department of Health (DH)

Family Health Service (FHS)

Intention-to-treat (ITT)

Maternal and Child Health Centres (MCHCs)

Nursing Officer (NO)

Nursing Officer In-charge (NOIC)

Principle Nursing Officer (PNO)

Randomised controlled trial (RCT)

Scottish Intercollegiate Guidelines Network (SIGN)

Senior Nursing Officer (SNO)

Vaccine-preventable diseases (VPDs)

World Health Organization (WHO)

1

Chapter 1: Introduction

1.1 Background

Immunization is the core health intervention of controlling, reducing and eliminating

infectious diseases. According to World Health Organization (WHO) (2013),

immunization protects children from the threat of vaccine-preventable diseases

(VPDs). It is estimated that deaths caused by traditional VPDs has fallen from 0.9

million in 2000 to 0.4 million in 2010. Thus, vaccinated children have the chance to

survive and a better opportunity of developing their full potentials in the future. The

ultimate goal of immunization is all people in every part of the world are free from

VPDs (WHO, 2013).

According to the Department of Health (DH) (2015), the number of notifications of

VPDs remains low in Hong Kong. This success, especially in preventing VPDs in

infants and children, is achieved by the Maternal and Child Health Centres (MCHCs)

under the Family Health Service (FHS) of DH. The MCHCs administer the

vaccination according to the Hong Kong Childhood Immunisation Programme

(Appendix A), which is updated based on scientific advice, for children below six

years of age (FHS, 2013). The programme nowadays protects infants and children

from eleven communicable diseases, including tuberculosis, hepatitis B, diphtheria,

tetanus, pertussis, poliomyelitis, pneumococcal infection, varicella, measles, mumps

and rubella (FHS, 2014). The Child Health Survey revealed 93.6% of children aged 0

to 14 had been vaccinated according to the recommended schedule with the majority

of vaccinated children attend the public sector for immunization between 2005 and

2

2006 (Centre for Health Protection, 2010). Approximately six hundred thousand

vaccines were administered in MCHCs, the coverage of vaccination under the

immunization programme is highly satisfactory (FHS, 2013).

In order to maintain the satisfactory immunization coverage, children need to receive

at least 14 shots of vaccine under the age of six, some children may need to receive

more vaccines due to their own physical condition. They may also receive more than

one shot during a single visit.

Through immunization is a powerful medicine in protecting people from

communicable disease, immunization-induced pain reduces immunization adherence

(Taddio et al., 2009). Abundant researches have been done finding ways of reducing

pain during immunization, especially for infants and children as their untreated

procedural pain leads to distress to them, their parents and health care providers

(Taddio et al., 2009; Wallace et al, 2014). Although scientifically proven pain

management is available, they are seldom used.

1.2 Affirming the Needs

The untreated pain experienced by children during medical procedure reduces their

level of cooperation, causing difficulty in carrying out the treatment and is associated

with more negative memories leading to fear at future procedure or needle phobia

(Taddio et al, 2009). Parents and health care providers also showed concern regarding

the potential of pain during vaccination (Wallace et al., 2014). Research determining

parents’ and physicians’ opinions about the administration of multiple childhood

3

vaccination at a single visit, it is found that immunization-induced pain is the most

frequently expressed and main concern by both parties (Woodin et al., 1995). All

mothers are distressed during children immunization (Parvez et al., 2010). Concern

about the unrelieved pain during vaccination is an important factor for nonadherence

to immunization schedule as parents do not want their children suffer from pain or all

injections to be given at a time (Taddion et al., 2009). Nonadherence to immunization

schedule not only puts the children at risk, it also diminishes herd immunity and

results in reviving of infectious diseases (Primary Care Office, 2015; Taddio et al.,

2009).

The above phenome are observed in MCHCs. Children are anxious during

immunization. They struggle throughout the procedure. Parents are also anxious

during the process and do not cooperate with the injection nurses which may even

lead to conflict between them. Multiple injections during a single visit also increases

stress of nurses.

The primary reason for parents do not managing immunization-induced pain for their

children is knowledge deficient regarding the scientifically proven pain management

(Parvez et al, 2010; Taddio et al., 2007; Taddio et al., 2009). The cause of this

situation is that health care providers do not advise parents about the immediate pain

relief measures but focus on educating parents regarding the adverse reactions that

develop later (Taddio et al., 2009). The same situation is observed in the public sector

in Hong Kong. Nurses at MCHCs put lots of effort in educating parents and

caregivers about the reaction, side effect and aftercare of immunization. Interventions

of mitigating the immediate immunization-induced pain are not mentioned as there is

4

no specific guideline or instruction in tackling the issue.

WHO Regional Office for Easter Mediterranean (2013) defined health education as

educational, motivational skill-building and consciousness-raising techniques which

enhances an individual capacity to make appropriate decisions regarding health. Thus,

health education directed to parents regarding mitigating pain of their children during

immunization equips them capacity to make appropriate decision in the pain relief

measures to be used and to improve the quality of life of both parents and children.

Since there is no educational intervention regarding pain management strategy for

immunization-induced pain of children available in current practice in MCHCs, it is

essential to put effort in developing an evidence-based guideline regarding the issue.

There are researches show that parent-directed education program increases parents’

knowledge and utilization of the scientifically proven pain management during

childhood immunization. However, there is no systematic review on this area.

Therefore, it is essential to collect and evaluate the existing researches to determine

the effectiveness and feasibility of implementing an evidence-based parent-directed

education program regarding pain management for infants and children in MCHCs in

order to improve the service.

1.3 Objectives and Significance

1.3.1 Objectives

- To review current literatures on education program directed to parents regarding

5

pain management during childhood immunization in increasing knowledge and

utilization of pain management systematically

- To determine the implementation potential of a parent-directed education program

in MCHCs

- To develop an evidence-based practice guideline based on the identified evidence

1.3.2 PICO components

The target population of the innovation are parents or caregivers of children aged one

month to six years old undergoing routine immunization in MCHC. The intervention

is to offer evidence-based education program, including administrating pamphlet and

showing video, to the target population before routine immunization. Compared to

current practice with no intervention, the outcomes are to increase parents’ knowledge

and utilization of pain management during childhood immunization.

1.3.3 Significance

Teaching parents scientifically proven pain management promotes children, as well as

parents, the ability to cope with painful situation and reduces their sense of

helplessness (Schechter et al., 2007). Parents are willing to learn and use the pain

management to minimise pain in their children during immunization (Parvez et al.,

2010; Taddio et al., 2007). The proposed innovation can improve the quality of the

parents and children as they can transfer the learnt pain management to other clinical

setting in the future (Taddio et al., 2014b). It also helps improving client and health

care provider relationship.

6

Chapter 2: Critical Appraisal

After affirming the needs, setting the objectives and emphasising the significance of

the proposed innovation, the search and appraisal strategies together with summary

and synthesis of results will be discussed in this chapter.

2.1 Search and Appraisal Strategies

To search for studies relevant for critical appraisal, electronic databases for searching

were identified. Besides, the keywords used for locating relevant studies were

developed and criterias for study selection were set up.

2.1.1 Electronic databases and keywords for searching

Three electronic databases, including British Nursing Index, ISI Web of Science and

PubMed, were used for searching relevant studies. Eligible studies for critical

appraisal were located by the following five sets of keywords:

1) “Parents” or “Caregivers”

2) “Immunization” or “Vaccination” or “Injection”

3) “Education” or “Teaching” or “Learning” or “Patient education handout” or

“Video-audio media”

4) “Infants” or “Newborn” or “Preschool children”

5) “Pain” or “Pain management”

Each set of keywords was searched independently without and restriction or limitation

7

first. The results of each set of the keywords were combined to search in order to

minimise missing of any relevant studies. Reference lists of selected studies were

screened manually so to identify additional studies for critical appraisal.

2.1.2 Selection criteria

Inclusion and exclusion criteria were set to find out the most relevant articles for

critical appraisal.

Studies met the following criteria were included for critical appraisal:

1. Target group of the study was parents or caregivers of health children under six

years of age undergoing immunization.

2. Method for vaccination was injection.

3. Intervention was related to any form of health education intervention.

4. Outcome measures were level of knowledge and/ or utilization of scientifically

proven pain management.

Studies met the following criteria were excluded from the critical appraisal:

1. Target group of the study was parents or caregivers of preterm children or children

with congenital illness.

2. Not evaluating the effectiveness of any form of educational intervention of

teaching pain management regarding immunization.

8

2.1.3 Appraisal strategies

Data from the relevant studies were extracted and tabulated in the table of evidence

for easy comparison among the studies. The quality of the selected studies were then

critically assessed as suggested by Scottish Intercollegiate Guidelines Network

(SIGN) (2014). The SIGN Methodology Checklist 2: Controlled Trials was used to

assess the internal validity as well as the overall assessment of the study with grading

assigned according to how well the study was done (SIGN, 2012). Strength of the

selected studies were graded according to the level of evidences recommended by

SIGN (2014) (Appendix B).

2.2 Results

2.2.1 Report of the search result

Eligible studies were searched between 21 November, 2015 and 9 December, 2015 by

three electronic databases including British Nursing Index, ISI Web of Science and

PubMed. A total of 55 citations were generated by using a combination of the five sets

of keywords described previously. After removing duplicated studies from the search,

44 citations remained for further screening. After screening the titles and abstracts of

the citations, 38 of them were excluded due to the studies not related to childhood

immunization, parents’ education and pain management. The remaining 6 studies

were assessed thoroughly by reading the full text. One of them were excluded as the

article was testing the usability of an educational pamphlet and video about infant

immunization pain management not evaluating the effectiveness of the educational

9

intervention. Manual searches of the reference lists of the eligible studies for

identifying additional studies were performed. However, no additional studies were

found. Thus, a total of five studies were selected for critical appraisal. The PRISMA

Flow Diagram (Moher, Liberati, Tetzlaff, Altman & The PRISMA Group, 2009) in

Appendix C summarised the systematic search result.

2.2.2 Summary of the data extracted

The study design, quality of the study, sample characteristics, details of the

intervention and control, outcome measures and effect size of the five identified

studies were extracted and presented in a table of evidence for easy comparison.

Appendix D shows the complete table of evidence.

Nature of studies

All these five identified studies were written in English. Four of them used the design

of randomised controlled trial (Bustos, Jaaniste, Salmon & Champion, 2008; Cohen et

al., 2015; Taddio et al., 2014b; Taddio et al., 2015), while one used the design of

controlled trial without randomisation (Taddio, et al., 2014a).

Three of them were conducted in a single centre (Bustos, Jaaniste, Salmon &

Champion, 2008; Cohen et al., 2015; Taddio et at., 2014b) whereas two were

conducted in multiple centres (Taddio et al., 2014a; Taddio et al., 2015). The studies

were published between 2008 and 2015. All the studies were carried out in western

countries, including Australia (Bustos et al., 2008), the United States of America

(Cohen et al., 2015) and Canada (Taddio et al., 2014a; Taddio et al., 2014c; Taddio et

10

al., 2015).

Sample characteristics

Parents of healthy children below six years of age undergoing immunization who also

met the inclusion and exclusion criteria of the studies were recruited. The sample

sizes of the five identified studies ranged from 60 to 440 with total 842 subjects

involved. The mean age of subjects ranged from 30 years old to 38 years old with the

majority of subjects were female.

Bustos et al. (2008), Cohen et al. (2015) and Taddio et al. (2015) recruited subjects in

the clinic setting while Taddio et al. (2014a) and Taddio et al. (2014c) recruited their

subjects in the hospital setting.

Characteristics of Intervention Group

Bustos et al. (2008), Taddio et al. (2014a) and Taddio et al. (2014c) provided printed

materials to subject while Cohen et al. (2015) showed the animation. Taddio et al.

(2015) combined both printed materials and video as the intervention.

Three studies did not have time limit for the intervention (Bustos et al., 2008; Taddio

et al., 2014a; Taddio et al., 2015) while the other two limited the time for intervention

to around 10 minutes (Cohen et al., 2015;Taddio et al.,2014c).

11

Characteristics of controlled group

The control group of four of the studies were standard care as usual practice (Bustos

et al., 2008; Cohen et al., 2015; Taddio et al., 2014a; Taddio et al., 2015) while the one

conducted by Taddio et al. (2014c) used factsheet on normal growth substituted the

intervention.

Outcome measure

Level of knowledge and utilization of pain management were used as outcome

indicators in the identified studies. Cohen et al. (2015), Taddio et al. (2014a) and

Taddio et al. (2014c) used knowledge test to assess participants’ level of knowledge.

Bustos et al. (2008), Cohen et al. (2015) and Taddio et al. (2015) measured the use of

pain management by observation while Taddio et al. (2014a) and Taddio et al. (2014c)

relied on self-report of the pain management strategies used.

Effect size

The difference between intervention group and control group with p value <0.05

regards as significant difference

2.2.3. Summary of the appraisal results

The internal validity and overall quality of the studies were assessed by the SIGN

Methodology Checklist for Controlled Trials (2012) which were presented in

12

Appendix E.

All the identified studies had appropriate and clearly focused question. Four of the

identified studies randomly assigned subjects to treatment or control groups by

computer generated random numbers table (Bustos et al., 2008; Cohen et al., 2015;

Taddio et al., 2014c; Taddio et al., 2015) while one study allocated subject to

treatment group without randomisation (Taddio et al., 2014a).

Allocation concealment methods were mentioned in three of the identified studies.

Allocation of participants of the study by Cohen et al. (2015) remained concealed in a

binder. Taddio et al. (2014c) used sequentially numbered opaque sealed envelopes as

concealment method. The study by Taddio et al. (2015) was a cluster randomised

controlled trail (RCT). No concealment method was used in the study by Taddio et al.

(2014a) as it was not a RCT. Concealment method in the study by Bustos et al. (2008)

was not mentioned in the text.

Studies conducted by Bustos et al. (2008), Cohen et al. (2015) and Taddio et al.

(2014c) were single-blinded while studies conducted by Taddio et al. (2014a) and

Taddio et al. (2015) were double-blinded.

Among five of the identified studies, the treatment and control groups of four of them

were similar at the beginning of the trial (Cohen et al., 2015; Taddio et al.,2014a;

Taddio et al., 2014c; Taddio et al.,2015) expect the one done by Bustos et al. (2008) in

which the characteristic of participating parents were not adequately described. The

only difference between the intervention and control groups of all studies were the

13

parent-directed educational intervention in the intervention group. Outcome of all the

identified studies were measured in standard, valid and reliable instruments.

Except the study conducted by Cohen et al. (2015), all the identified studies stated

their drop-out rate clearly. Study performed by Bustos et al. (2008) had zero attrition

rate so there was no need to apply intention-to-treat (ITT). The overall drop-out rate

of the remaining three studies ranged from 19.5% to 31.7% (Taddio et al.,2014a;

Taddio et al., 2014c; Taddio et al.,2015). Only the one conducted by Taddio (2014b)

used ITT. Through modified ITT was used in the study by Taddio (2015), there was

no clear explanation for the reason. Studies conducted by Cohen et al. (2015) and

Taddio et al. (2014a) did not use ITT.

The results found by Taddio et al. (2014a) and Taddio et al. (2015) were comparable

for all sites whereas the remaining studies were single site.

Based on the above assessment, three studies were done well to minimise the risk of

bias in high quality (Cohen et al., 2015; Taddio et al., 2014c; Taddio et al., 2015). Two

kept the risk of bias to an acceptable level (Bustos et al., 2008; Taddio et al., 2014a).

All the studies calculated sample size carefully to meet the statistical powers. As a

result, level of evidence of the studies conducted by Bustos et al. (2008) was rated as

1+ while studies conducted by Cohen et al. (2015), Taddio et al. (2014c) and Taddio et

al. (2015) were rated as 1++. As the study carried out by Taddio et al. (2014a) was not

a RCT, it was rated as 1-.

14

2.3 Summary and Synthesis

All studies evaluated the effectiveness of parent-directed educational materials by

either statistically significant increase in knowledge or use of well researched pain

management in the intervention groups when compared with the control groups.

Summarising the conclusions of the included studies, it was found that simple and low

cost intervention can increase knowledge and change the behaviour of parents during

childhood immunization. Through the interventions were effective, there was degree

of diversity among the studies.

2.3.1 Summary of data

The identified studies mainly used two types of educational intervention, printed

material and video-audio media, in directing the pain management to the subjects. The

printed materials used by Bustos et al. (2008), Taddio et al. (2014a), Taddio et al.

(2014c) and Taddio et al. (2015) were in one page. The information sheet used by

Bustos et al. (2008) were words describing the coping-promoting behaviour. In the

studies conducted by Taddio et al. (2014a), Taddio et al. (2014c) and Taddio et al.

(2015), they used the same pamphlet on pain management. Other than words

description, there were pictures illustrating the use of pain management which

visualized the strategies towards the participants. Taddio et al. (2015) even used poster

size pamphlet to magnify the effect of the pamphlet.

The video-audio material shown by Cohen et al. (2015) was in the form of animation

while the one by Taddio et al. (2015) was filmed on real situation. The mode of

15

delivering was also different. Cohen et al. (2015) showed the animation by computer

with preventing the participants from skipping the important massage by pressing the

“Next” button of each session of the program while Taddio et al. (2015) showed the

video continuously in the waiting area.

The time of administering the educational intervention was different among the

studies. Bustos et al. (2008) and Taddio et al. (2014a) offered the information

materials to the participants before the day of immunization while Cohen et al. (2015)

Taddio et al. (2014c) and Taddio et al. (2015) offered the educational material on the

same day of immunization or outcome measure.

Taddio et al. (2014a) and Taddio et al. (2015) did not give special attention to their

subjects in reading the material while Bustos et al. (2008), Cohen et al. (2015) and

Taddio et al. (2014c) directed their subjects in reading it. Three of the studies do not

limit time for reading the materials (Bustos et al., 2008; Taddio et al., 2014a; Taddio et

al., 2015). Two studies limited the subject to read the materials in ten minutes (Cohen

et al., 2015; Taddio et al., 2014c)

The outcome measures for increase in knowledge level and use of scientifically

proven pain management of subjects were different among studies. For increase in

knowledge, Cohen et al. (2015) used Parent Procedural Behavior Knowledge Test

supplemented with visual analog scale to gather parent behavioural knowledge while

Taddio et al. (2014a) and Taddio et al. (2014c) used knowledge test based on the Help

Eliminate Pain in Kids clinical guideline to assess parents’ knowledge.

16

All identified studies measured the use of pain management as outcome. Bustos et al.

(2008) observed the verbatim used by parents and coded by Child-Adult Medical

Procedure Interaction Scale-Revised. Cohen et al. (2015) observed parents’ behaviour

3 minutes before cleaning the skin till 3 minutes following the removal of needle or

parents left treatment room and coded by the behavioural coding scales. Research

assistants of the study conducted by Taddio et al. (2015) observed the use of pain

management strategies at the right time of each strategy without any coding scale.

Taddio et al. (2014a) and Taddio eat al. (2014c) relied on self-report of the pain

management used.

2.3.2 Synthesis of data

Parent-directed educational program could significantly increase the knowledge and

utilization of scientifically proven pain management of parents in MCHCs. The use of

pamphlet showed significant improvement in knowledge gain compared to no

intervention (Tuong, Larsen & Armstong, 2014). Showing video in general practice

waiting area was practical, acceptable and useful to a wide range of patients

(Koperski, 1989; Tuong et al., 2014). Combination of both printed and video-audio

materials was useful in magnifying the effect of the educational intervention. Among

all the identified studies, the effect size of utilization of pain management in the study

by Taddio et al. (2015) was the highest immediately after the implementation of the

educational intervention and showed significantly differently compared with standard

care. The effect persisted even after next vaccination. People with different

educational background benefited from combining video and written material (Stalker

& Elander, 2015). Less educated population benefited from video components which

17

were constructed carefully while highly educated population benefited from written

materials. Parents should be given written information as well as visualization for

ways to reduce pain in their children (Taddio et al., 2009; Taddio et al., 2013). Thus,

combining written material and video improve knowledge of health across people

with different education level, reaching health equality.

Education materials should be directed or reminded parents to read by health care

providers in order to enhance the knowledge and use of the strategies. Directing

participants reading and watching the educational materials showed significant

difference with the knowledge and use of pain management. Taddio et al. (2014a) did

not give special attention to their subjects in reading the material while Bustos et al.

(2008), Cohen et al. (2015) and Taddio et al. (2014c) directed their subjects in reading

or watching the educational materials. The immediate increase in knowledge and use

of pain management were significant with effect size ranged from 5.9 to 31.36 (Cohen

et al., 2015; Taddio et al., 2014c) and -0.07 to 2.32 (Bustos et al., 2008; Cohen et al.,

2015) respectively. Although studies conducted by Taddio et al. (2014c) reported an

increase in knowledge the next vaccination after the implementation of intervention,

the effect size was not as significant as those by Cohen et al. (2015). This might due

to subjects forgot the intervention after a long period of time.

Study by Taddio et al. (2014a) alone also concluded that participants who read the

information sheet, with effect size 1.0, significantly improved their knowledge

compare with the participants who did not read the pamphlet, with effect size 0.4,

even given to them.

18

Education intervention should be provided immediately or on the same day of

immunization to achieve the most significant outcome. For the outcome of

knowledge, the effect size of studies which provided information on the same day of

immunization or outcome measure was much higher than that after a long period of

time before the outcome measure. The effect size ranged from 5.9 (Taddio et al.,

2014c) to 31.36 (Cohen et al., 2015) with p value less than 0.05 compared with 1.0

with p value equal to 0.023 (Taddio et al., 2014a). The same phenomenon was also

observed in the outcome of utilization of pain management with effect size ranged

from -0.07 (Cohen et al., 2015) to 43 (Taddio et al., 2015) compared with 2.31

(Bustos, et al., 2008). It was concluded that intervention should be delivered on the

day of the outcome measure.

2.3.3 Implication for practice

Parent-directed educational materials provided on the day of the vaccination can

increase the knowledge and utilization of pain management of parents during

immunization of children under six years old. It is recommended that the use of

printed and video-audio materials could be incorporated into the setting of MCHC

with the development of an evidence-based practice guideline in order to alleviate the

distress towards children, parents and health care providers as well as elevate the

adherence to the immunization schedule. Thus, the health of the whole community

can be safeguarded.

19

Chapter 3: Implementation Potential and Clinical Guideline

Before setting up a clinical guideline for the proposed innovation, the implementation

potential of the innovation should be considered, particularly the transferability,

whether the implementation of the innovation is suitable for a particular setting;

feasibility, whether any resources and support are available for the implementation of

the innovation; and cost-benefit ratio, whether it is worthwhile to implement the

innovation by considering the strengths and weaknesses of implementing and not

implementing the innovation (Polit & Beck, 2012).

3.1 Transferability

3.1.1 Target setting

There are thirty one MCHCs in Hong Kong implementing an integrated child health

and development program to promote health and wellbeing of children, in which

immunization is one of the core components of the program (FHS, 2014). Children at

or below 18-month-old are advised to have immunization as scheduled in MCHCs

while children 6 years old or below with incomplete immunization schedule can also

return to MCHCs for catching up the schedule. Around 84% of local born children

receive vaccines at MCHC (FHS, 2013).

The chosen MCHC is the busiest centre in New Territories West Cluster 2. Children

receive immunization during the child health service session of the target centre. It is

20

observed that around 85% of attendance received immunization at the target MCHC

in 2015.

3.1.2 Target audience

Parents usually accompany their child for immunization. After registering the service

of that day, nurses will interview parents whether the child is suitable for

immunization or not. The child will be proceed for vaccination if he or she is fit for

immunization. The target population of the proposed innovation is parents of child

receiving immunization in MCHC.

Considering the similarity of characteristics and philosophy of care between the

identified studies and the target setting as well as the target population, it helps in

determining whether the findings of the selected studies are transferable or not. The

number of clients who will be benefited from the innovation should be sufficiently

large. The time for implementation and evaluation should not be too long so it is

worth to carry out.

3.1.3 Similarity of the setting between the identified studies and the target setting

All the identified studies were carried out in developed countries, including Australia

(Bustos et al., 2008), USA (Cohen et al., 2015) and Canada (Taddio et al., 2014a;

Taddio et al, 2014c; Taddio et al., 2015). All these countries have well designed

immunization program to protect infants and children from infectious disease. The

21

Hong Kong Childhood Immunization Programme aims at protecting children staying

in Hong Kong away from VPDs.

Three of the reviewed studies recruited subjects and were took place in outpatient

immunization clinic (Bustos et al. 2008; Cohen et al., 2015; Taddio et al., 2015).

Through the studies done by Taddio et al. (2014a) and Taddio et al. (2014c) recruited

their subjects in the hospital setting, they evaluated the effectiveness of the

intervention after the subjects experienced childhood immunization. According to the

Government of Canada (2015), children in Canada receive free routine immunization

in outpatient clinic. Since the children of the identified studies were vaccinated in

outpatient clinic where shared the same characteristic as the MCHCs in the

community, the proposed innovation fits in the target setting.

3.1.4 Philosophy of care

The MCHC is a branch under FHS of DH. The vision of FHS is using strategies and

programs which are evidence-based to empower individuals, families and the

communities to promote the well-being and health of children and their families in

Hong Kong (FHS, 2014). The Human Care Science theory proposed by Waston

(1985) pointed out nursing should integrate science with the respect to the values of

human. The principle of the proposed innovation is in line with the vision of FHS and

the Human Care Science theory which aims to educate parents and empower them

with the skills regarding scientifically proven pain management to reduce painful

sensation of children during immunization, offering holistic care to both children and

their family by scientific strategies.

22

3.1.5 Similarity of characteristic of population between the identified studies and

the target setting

The subjects of the identified studies were parents who experienced the process of

immunization with their children ranged from infants (Bustos et al., 2008; Taddio et

al., 2014a; Taddio et al., 2014c; Taddio et al., 2015) to age between four and six years

(Cohen et al., 2015). The age range of children of the research audience fully covers

the service population of the target MCHC which offers service to children aged

below six years old.

3.1.6 Number of clients benefited from the innovation

Based on clinical observation, around 21316 children attending the child health

service session received immunization in the target MCHC in 2015. It is estimated

that parents of 1776 children per month, a sufficiently large number of clients, will be

benefited from the innovation.

3.1.7 Length of time for implementation and evaluation

It is expected that from preparation, implementation to evaluation, the innovation will

take approximately twelve months to be completed (Appendix F). The proposed

innovation will take two months for setting up working group to prepare proposal and

guideline of the education program, two months for seeking approval by the

administrative level of the department, another two months for preparation of

education pamphlet and video, one month for training the staff regarding the

23

scientifically proven pain management and the flow of the program, two months for

implementation and evaluation of the pilot testing and refining the guideline, one

month for formal implementation with three months of data analysis and evaluation of

the program.

Since the proposed education program shares similar characteristics in target setting,

audience and philosophy of care with a sufficiently large number of target population

being benefited in a reasonable length of time, the proposed innovation is transferable

in the target MCHC.

3.2 Feasibility

Support from the organization, the administrative level as well as frontline nurses

makes the implementation of an innovation easier. The availability of essential

resources and equipment helps smooth the process of implementation.

3.2.1 Organizational climate and administrative support

As stated in the mission statement of FHS, the organization supports the use of

evidence-based practice to improve the quality of care. Eliminating aspiration during

intramuscular vaccination, introduction of Pneumococcal Conjugate Vaccine and

Varicella Vaccine in 2009 and 2015 respectively and updating Childhood

Immunization Guideline periodically demonstrate the determination of FHS in

utilizing evidence-based result.

24

The administrators also support innovations and suggestions. “Sharing of Good

Practice Scheme” encourages exchange of new ideas to improve the delivery of

service. The Nursing Officer In-charge (NOIC) of the target MCHC welcomes

suggestions from frontline nurses to facilitate the process of service delivery

especially in the area of immunization. It is believed that the innovation can smooth

the process of immunization and is worth to be tested.

3.2.2 Consensus and friction among nurses

Half of the nurses in the target MCHC are university graduates. It is expected that

they are willing to accept the innovation as evidence-based practice is strongly

emphasised in their training. The major pocket of resistance which undermines the

efforts to implement and evaluate the innovation comes from the senior staff. Since

the senior staff have been working in the clinical setting for years, they usually make

clinical decision based on their own clinical experience without being proven

scientifically or on outdated belief. For example, nurses in the target MCHC prohibit

infant to be breastfed during vaccination, which is one of the well proven effective

strategies in relieving pain during immunization, as they believe drinking during

vaccination may led to choking.

3.2.3 Interference to current practice

The usual workflow for a child having immunization is registration first, measuring

growth parameter by nurse next, parents are then interviewed by nurse for dietary

habit of the child, developmental surveillance and suitability for immunization on that

25

day. The interview usually takes approximately 20 minutes to be completed. If the

children is suitable for immunization, the nurse will introduce the vaccine(s) and side

effects that the child will have after vaccination. Parents and child will then wait in

the waiting area for immunization. The whole process takes around one and a half

hours to be completed.

The innovation may interfere the current practice as it requires the interview nurses to

introduce a pamphlet of scientifically proven pain management briefly at the end of

the interview and the parents need to watch the pain management video which lasts

for around 10 minutes before vaccination. The implementation may slightly increase

the time of the workflow.

Through the implementation may affect the efficiency of service delivery, nurses have

the freedom to control and terminate the innovation if it is considered to be

undesirable as it is sorely a nursing intervention. There is no special skill needed to

carry out the innovation. However, educating nurses regarding the scientifically

proven pain management described in the pamphlet and video is essential. The

education session can be held during the weekly clinical meeting so that nursing staff

need not to be released from duty, keeping the interference to current practice to be

minimal.

3.2.4 Availability of resources and equipment

The plan for implementation of the innovation is to briefly introduce the pain

management pamphlet to the eligible parents at the end of the interview and then

26

arrange them to watch the video in the function room at the target MCHC. Since there

is no pamphlet and video regarding the pain management strategies available in the

current practice, Health Information Section of FHS will be invited for the production

of the pamphlet and video. The content of both pamphlet and video will be based on

the pamphlet used in the reviewed studies by Taddio et al. (2014a), Taddio et al.

(2014c) and Taddio et al. (2015), except the part of applying topical anaesthetics as it

is out of the scope of the proposed innovation, in cooperation of the pain management

described by Bustos et al. (2008) and Cohen et al. (2015). Details of the content is

shown in Appendix G. The final version of the pamphlet will have picture to magnify

the effect of the pamphlet. The members of the workgroup will be filmed for the

production of the video, minimising the interference to the manpower of the target

setting during the phase of the preparation of equipment.

Other than the pamphlet and video, the target MCHC already has a video player and a

function room for implementing the innovation.

3.2.5 Evaluation tool

To evaluate the increase in knowledge level and utilization of scientifically proven

pain management of the parents, the knowledge test used by the studies of Taddio et

al. (2014a) and Taddio et al. (2014c) and observation of the use of the scientifically

proven pain management are used. The chosen knowledge test is demonstrated to be

feasible in determining knowledge of parents regarding pain management in multiple

studies in the relevant topic. It is a valid measuring tool in this area. The knowledge

test composed of 9 true/ false question after modification with the elimination of

27

question regarding the use of topical analgesia which is out of scope of current

innovation. Observation is used as the outcome measure of the utilization of pain

management as most of the identified studies apply observation as the outcome

measure (Bustos et al., 2008; Cohen et al. 2015; Taddio et al., 2015) and it is much

more objective than self-report by parents. Details of the evaluation plan will be

discussed in the next chapter.

The proposed innovation is highly feasible in the target setting with supportive

organizational climate and frontline staff with minimum interference to current

practice.

3.3 Cost-Benefit Ratio

Balancing the cost of implementing and not implementing the innovation can

visualize the benefits of the innovation.

3.3.1 Potential risk of the innovation

The innovation is solely an education intervention. Thus, the risk of adverse exposure

is rare.

3.3.2 Potential benefits resulted from the innovation

Increasing parents’ knowledge regarding scientifically proven pain management

during childhood immunization helps alleviate stress and anxiety of parents as well as

28

reduces anxiety and irritability of children. On one hand, the level of cooperation of

both parents and children will increase during the procedure, minimising the chance

of injection incident. Thus, it reduces the stress of nurses during injection. On the

other hand, the chance of potential conflict between parents and nurses will reduce,

saving time for managing conflicts and increasing rapport between parents and nurses.

The sense of job satisfaction of nurses will increases.

The innovation also enhances the organization’s image as it offers holistic care to both

the children who receive direct service and their families. Alleviating distress of

parents regarding immunization also increases compliance of parents to adhere to

immunization schedule and willingness of parents to let their children receive multiple

vaccination in a single visit. On one hand, it safeguards the health of the public. On

the other hand, it reduces work stress of nurses as it helps reduce caseload of the

target setting as well as reduces resource for tracing defaulter of immunization. Thus,

staff morale and staff retention will be enhanced.

3.3.3 Risk and cost of maintaining current practice

Maintaining current practice without scientifically proven pain management advice

keeps children and parents uncooperative during vaccination. Children may develop

needle phobia in the future, parents will not adhere to the immunization schedule and

separate visit will be needed for catching up the immunization schedule of the same

children. Workload of nurses may thus increase.

29

3.3.4 Cost of the innovation

The material cost of the innovation is the production of evidence-based practice

guideline, pamphlet, video and evaluation form. The non-material cost comes from

time educating parents regarding the scientifically proven pain management described

in the pamphlet and video. Based on the information given by Civil Service Bureau

(2015), the mean monthly salary of a registered nurse in DH at Master Pay Scale point

19 is $32560 per month. It is estimated that the total material and non-material cost of

the innovation is $19707 per 1000 subjects per month (Appendix H). Financial

support will be granted from DH.

3.3.5 Cost of not implementing the innovation

Through it is observed that only 2% of parents prefer to spread immunization of their

children in a separate visit, additional visit of the same children puts a great burden to

the target MCHC. Extra 20 minutes and 5 minutes are needed for interviewing parents

and vaccinating children respectively for a repeated visit. Although the estimated cost

of repeated visit is far less than the implementation of the innovation (Appendix F),

the repeated visit will occupy the vacancy of booking, delaying the immunization

schedule of another child as there is quota system to control the clients being served

in the target setting. To minimise the risk of delaying immunization, additional quotas

are added for those who are on time for immunization, increasing workload as well as

reducing morale of nurses.

Since the benefits of the innovation outweigh its cost, it is valuable to implement the

30

innovation.

3.4 Evidence-Based Practice Guideline

Since the proposed innovation is transferable, feasible and cost effective, an evidence-

based practice guideline should be set up to facilitate implementation and

communication.

The recommendations of the guideline are based on the five reviewed research. A

grade is given to each recommendation so to determine the strength of evidence. The

grade is based on the Grades of Recommendation suggested by SIGN (2014)

(Appendix J).

The guideline with title “An evidence-based parent-directed education program in

increasing knowledge and utilization of pain management during childhood

immunization” is set up. It is targeted to be used by all nurses responsible for

interviewing parents before childhood immunization. The target group is the parents

of children below six years of age receiving immunization in the target setting. The

ultimate goal of the guideline is to increase parents’ knowledge and utilization of

scientifically proven pain management during childhood immunization. The full

version of the guideline is shown in Appendix K.

31

Chapter 4: Implementation Plan

Though the implementation potential of the proposed parent-directed education

program is affirmed with the evidence-based practice guideline being developed, a

detailed implementation plan, including communication plan for convincing the

stakeholders, pilot study for testing the feasibility of the innovation and plan for

evaluating the success of the innovation, is needed for action.

4.1 Communication Plan

4.1.1 The stakeholders

Stakeholders are those people or organization who have vested interests in the process

and outcome of the proposed innovation (Centers for Disease Control and Prevention,

2012; Schmeer, 1999). Identifying stakeholders is the fundamental step of proposing

any innovation as knowing the interests and concerns of each party helps developing

communication plan in promoting support and minimising opposition from them.

Three levels of stakeholders are identified in the proposed innovation. Approval

should be granted from the higher level of an organization before the implementation

of any new ideas. Gaining support from the administrative level of FHS, including the

Senior Nursing Officer (SNO) of New Territories West Cluster II, Chief Nursing

Officer (CNO) and Principle Nursing Officer (PNO), helps getting both material and

non-material support which facilitate the implementation of the innovation.

The innovation is carried out by frontline staff. Therefore, motivating the people at

clinical level to participate actively is essential. The first step is proposing the idea to

32

the NOIC of the target MCHC as she is the leader of the clinic. She helps conveying

the message to the administrative level for approval. She also supervises the overall

operation of the innovation and makes appropriate adjustment between the innovation

and routine functioning of the clinic. Frontline nurses are the actual users of the

guideline. Getting their support and cooperation makes the implementation of the

innovation much easier.

Parents of the children who receive immunization in the designated clinic are the

actual recipients of the innovation. Communicating with them helps understanding the

effectiveness of the innovation.

4.1.2 The process of communication

The communication process should be started by approaching the NOIC. Discussing

the observed problem and the need for change of current practice arouse her interest

of the innovation. Informing the benefits and evidence behind the innovation

increases her understanding. Indicating the aim of the innovation makes her with a

clearer idea on how to accomplish the goal.

When NOIC agrees for the innovation, a working group will be set up to prepare

proposal for approval from administrative level, develop the guideline, prepare

necessary equipment for the innovation and design timeline to guide the change. The

working group will consist of one Nursing Officer (NO) and two Registered Nurses

including the subject nurse of immunization in the target clinic. These three members

will share the responsibility and reach consensus regarding the details of the education

33

program. Bi-weekly meetings in two-month time in the preparatory phase will be

necessary to come to a unanimous decision of the innovation.

The proposal will be presented to the SNO to gain her approval and support next.

With the help of NOIC and NO in the working group, SNO will be invited to attend a

one-hour meeting regarding the innovation in the clinic. Other than the proposal, the

cost and benefit of the innovation will be emphasised so that she will have a clearer

picture of the benefit of the innovation as it will be launched in the other MCHCs if

the innovation is successful in the target clinic. Higher level of approval from CNO

and PNO should be gained through SNO. It is estimated the process will take three

months to be completed.

After gaining approval from the administrative level, launching of the education

program should be disseminated to frontline staff during clinic meeting. Informing the

staff the reason behind the innovation increases their awareness and acceptance of

teaching parents pain management during immunization. Persuading them with the

benefits from implementing the new idea reduces their resistance. Introducing the

guideline, education materials and logistic of the innovation smoothens the process of

the implementation. Encouraging staff to express their concerns, questions and

opinion helps revise the guidelines before implementation. Two clinic meetings will

be held for this purpose with each meeting last for one hour.

The ultimate goal is to introduce scientifically proven pain management to the parents

through the parent-directed education program. The education pamphlet will be

briefly introduced to parents by nurses while the education video will be broadcasted

34

to parents in the function room before the children receive immunization. Evaluating

outcomes in different perspective helps sustaining the change. The evaluation plan

will be discussed later in this chapter.

4.2 Pilot Study Plan

A pilot test with a small number of clients representing the target group of the

innovation should be conducted to identify possible problems and make appropriate

correction before the actual implementation (Hodges & Videto, 2011). Participants

with the same inclusion and exclusion criteria of the innovation will be recruited in

the pilot study. 17 clients will be invited to participate in the pilot study. It is expected

that the study will take one service session to be completed.

Before the pilot study, briefing session regarding the parent-directed education

program will be given to the nurses in the target MCHC. The background, evidence,

content of the education pamphlet and video, the logistic of the education program

and data collection method will be introduced. The materials, including the education

pamphlet, video, video player and all the forms for evaluation will be prepared by the

working group prior to the beginning of the pilot study.

The clients will be recruited when they approach the registration counter for

immunization service for their children. The clerk in the registration counter will ask

for verbal consent from the parents for the pilot study. If the parents agree to join the

study, explanatory notes on the purpose of the innovation, consent form and the

knowledge test (Appendix L) will be given to clients as pre-test and clients will be

35

asked to fill in the knowledge test while they are waiting for a routine nurse interview.

The interviewing nurse will collect the consent form and pre-test before the routine

interview. At the end of the interview, the interviewing nurse will distribute the

education pamphlet with brief introduction of the pamphlet to the clients. The clients

will then be arranged to watch the video in the function room of the clinic. Each video

broadcasting session will accommodate 5 to 7 clients and will take around 10 minutes

to complete. The same knowledge test will be distributed to clients as post-test after

watching the video by one of the member of the working group and will be collected

before the children proceed to treatment room for immunization. A self-developed

satisfactory questionnaire will be distributed to clients before they leave the function

room and they will be reminded to fill in the questionnaire after immunization.

Another member of the working group will observe the behaviour of the parents

during childhood immunization in the treatment room using a standardised

observation form (Appendix M). The observation will start when the injection nurse

askes the client to prepare a child for immunization and will end when the client

leaves the room. The clients need to hand in the self-developed satisfactory

questionnaire (Appendix N) to the booking counter when they book the next

appointment before leaving the clinic.

The recruitment of clients will start at the second time slot of the service so the

routine service will not be interrupted. The three members of the working group will

take turns in the position of video broadcasting, observation of parents’ behaviour in

the treatment room and supporting the other staff so they can discuss the obstacles

each of the members have in different positions for refining the logistic. Feedback

36

from the staff involved in the pilot study, including the clerk, interviewing nurse and

injection nurse, will be collected in the clinic meeting after the pilot study.

Modification of the process of the innovation will be made accordingly before the full

implementation.

4.3 Evaluation Plan

Evaluation should be done to determine the success of the innovation and make

appropriate modifications for sustaining the change (Centres for Disease Control and

Prevention, 2012). Identifying the outcomes to be achieved, estimating sufficient

sample size to achieve statistical power, collecting data at an appropriate time and

analysing the data with correct method ensure the reliability of the results.

4.3.1 Outcomes to be achieved

Outcomes can be classified as three aspect, client outcome, staff outcome and system

outcome.

The primary outcome of client is to increase their level of knowledge of scientifically

proven pain management. The secondary outcome is to increase the use of

scientifically proven pain management during childhood immunization. The

knowledge test adopted by Taddio et al. (2014a) and Taddio et al. (2014c) is used to

assess the level of knowledge of clients. It is a valid tool as it is specifically designed

to assess the changes in knowledge uptake regarding the scientifically proven pain

relieving interventions based on the Help Eliminate Pain in KIDS clinical practice

37

guideline which summarises various scientifically proven pain relieving strategies

during childhood immunization (Taddio et al.,2014a; Taddio et al., 2014c). It consists

of 10 true or false question originally. Modification is made with the elimination of

the question regarding the use of topical analgesia which is not included in the

proposed innovation. Thus, the knowledge test composes of 9 questions to suit the

need of the innovation. It is expected that the level of knowledge related to

scientifically proven pain management will be increased by one level after receiving

the education program.

Observation of the use of scientifically proven pain management measure will be used

to assess the secondary outcome of client. Observation is chosen as the measuring tool

since three out of five of the selected articles observe the utilization of pain

management (Busto et al., 2008; Cohen et al., 2015; Taddio et al., 2015). It is much

more objective than self-report used by Taddio et al. (2014a) and Taddio et al. (2014c)

as parents may forget or not aware of the strategies that they have used. Clear

definition of use of each scientifically proven pain management is prepared before the

launching of the innovation. Thus, it will reduce the bias of inconsistency between

different observers. It is expected that the clients will use one or more scientifically

proven pain management, including sugar water, breastfeeding or bottle feeding and

holding child without instruction from the injection nurse, at the right time during

childhood immunization after the education program (Appendix M). These pain

management strategies are chosen since they are effective in relieving pain in infant

and children but uncommonly used (Taddio et al., 2015), which is the same

phenomenon observed in the target MCHC. They are also easily identified by the

observer of the working group during the vaccination.

38

For staff outcome, it is expected that frontline nurses will have positive attitude

towards the evidence-based parent-directed education program. A semi-structured

evaluation meeting with staff will be held to assess this outcome (Appendix O).

For the organization outcome, the reputation of the service will increase as the clients

will be more satisfied with the service. Self-developed satisfaction questionnaire

(Appendix N) is used to analysis the satisfactory level of client. It consists of 6 items

regarding the content of both pamphlet and video, whether the program increases

clients’ level of understanding and competence in managing childhood immunization

pain and the supportiveness of the staff. It is expected that the clients will have high

satisfactory level regarding the innovation.

4.3.2 Nature and number of clients involved

Since majority of the population in the target MCHC are Hong Kong Chinese, the

knowledge test and self-developed satisfactory questionnaire will be translated to

Chinese. Parents accompanying child for immunization in the target clinic who are

proficient in written Chinese and spoken Cantonese will be included. Parents of at risk

case, that is either parent with mental illness or substance abuser and teenage mother,

or parents of preterm baby are excluded.

Sample size calculation will be based on the primary outcome for estimation. Since

the standard deviation of change in knowledge is 3 in the selected studies, using one-

sample t-test with power of 0.8 and significance level of 0.05, 73 subjects will be

necessary for the evaluation of meaningful difference in knowledge level. Considering

39

an attribute rate of 10%, 82 subjects will be needed for the innovation. Convenient

sampling method will be used to recruit clients in 5 service sessions.

4.3.3 Time to take measurement

For both the primary, secondary and organization outcomes, the measurement will be

taken on the day when the clients agree for participating in the innovation. Knowledge

test will be given to clients prior to receiving any education materials regarding the

scientifically proven pain management as the pre-test on the day of receiving the

immunization service. After clients receives all the education material, the same

knowledge test will be given as post-test to determine the level of knowledge change.

A member of the working group will observe the use of scientifically proven pain

management during childhood immunization on the same day of receiving

intervention to determine the use of pain management. Clients need to fill in the

satisfactory questionnaire before leaving the clinic the same day for system outcome.

The semi-structured meeting for evaluating the staff outcome will be held in the

weekly clinic meeting one week after the implementation of the innovation to collect

feedback from nurses.

4.3.4 Data analysis

The data collected will be analysed by Statistical Package for Social Science (version

22) for Windows. For client outcome, one sample t-test will be used to analysis the

difference between the pre-test and post-test knowledge level. Logistic regression will

40

be used to analysis the use of scientifically proven pain management by clients as the

clients either use or no use of the pain management, a dichotomous variable. For staff

outcome, feedback in the semi-structured meeting will be summed up for evaluation.

Independent t-test will be used to analysis the satisfactory level of client for system

outcome. The demographic data of clients will be analysed by descriptive statistics.

It is estimated that the process of data analysis will take 4 weeks to be completed.

Evaluation of the whole implementation process will be finished within two weeks.

The whole process will take eight weeks to complete.

4.4 Basis for Implementation

For client outcome, based on the selected studies, it is found that the minimum

increase in knowledge is by mean of one after receiving the education program.

According to Taddio et al. (2014a), at least 10.5% of participants increase in level of

knowledge after the intervention. It is expected that 10.5% of parents with mean score

of the knowledge test increased by 1, the innovation is regarded as successful. The

innovation will be more persuasive if the secondary outcome is also achieved, that is

either 80% of parents use one or more pain management during immunization as the

result of Taddio et al. (2015).

The staff outcome is achieved if the nurses verbalise the innovation has positive

impact in their daily work, they have control over the innovation with the difficulties

can be overcome with minimal barriers during the semi-structured meeting. For the

41

system outcome, if more than 70% of parents report “strongly agree” or “agree” for

all items in the satisfactory questionnaire.

If the outcomes of the above three aspects are met, the implementation of innovation

in the target MCHC is regarded as successfully. The innovation will be fully

implemented in all the MCHCs in Hong Kong, providing benefits to more parents,

children, staff and the whole department.

42

Chapter 5: Conclusion

Immunization is a powerful strategy in reducing VPDs. The low level of notifications

of VPDs in infants and children is achieved by adherence to the Hong Kong

Childhood Immunisation Programme. Majority of infants and children are vaccinated

in MCHCs. To maintain the satisfactory level of protection, infants and children may

need to receive more than one injection in a single visit. The pain induced by

vaccination leads to distress in children, parents and health care providers. The

immunization-induced pain makes the children uncooperative during vaccination and

it may lead to needle phobia when they grow up. The unrelieved pain is a contributing

factor for nonadherence to immunization schedule as parents are stressful when they

witness their children suffer from immunization-induced pain. The uncooperative

behaviours of children or parents during vaccination increase the work stress of nurses

in MCHCs.

Although scientifically proven pain management are available, they are seldom used.

The reason behind is that there is no education intervention regarding pain

management during childhood immunization available in current practice of MCHCs.

Thus, parents do not know that an effective strategy can help their children to relieve

pain during vaccination. Through there are researches showing parent-directed

education program which can increase parents’ knowledge and utilization of pain

management during childhood immunization, there is no systematic review on this

area.

In this translational nursing research, five current literatures are reviewed

43

systematically. After determining the implementation potential of the innovation, an

evidence-based practice guideline is developed. It is target to be used by all nurses

interviewing parents of children receiving immunization in a target MCHC. The

printed and video-audio educational materials are offered to parents on the day of

childhood immunization to obtain the best result. A communication plan is contrived

to gain support from all the stakeholders. A pilot study and evaluation plan are

planned carefully before the actual implementation of the innovation. It is believed

that the guideline can increase parents’ knowledge and the use of scientifically proven

pain management during childhood immunization. Thus, the quality of life of both

parents and children as well as the quality of service of MCHCs will be improved.

Total Words: 9742

44

Appendix A

Hong Kong Childhood Immunisation Programme

Age Immunisation RECOMMENDED for infants and children below six

Newborn B.C G. Vaccine

Hepatitis B Vaccine – First dose

1 month Hepatitis B Vaccine – Second dose

2 month DTaP-IPV Vaccine – First dose

PCV – First Dose

4 month DTaP-IPV Vaccine – Second dose

PCV – Second dose

6 month Hepatitis B Vaccine – Third dose

DTaP-IPV Vaccine – Third dose

PCV – Third Dose

12 month MMR Vaccine – First dose

PCV – Booster dose

Varicella Vaccine – First dose

18 month DTaP-IPV Vaccine – Booster dose

B. C. G. = Bacille Calmette-Guerin;

DTaP-IPV = Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliovirus;

PCV = Pneumococcal Vaccine;

MMR = Measles, Mumps & Rubella

(FHS, 2014)

45

Appendix B Levels of Evidence

Levels of Evidence Description

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case report, case series

4 Expert opinion

(SIGN, 2014)

46

Appendix C PRISMA 2009 Flow Diagram

Iden

tifi

cati

on

Record identified

through database

searching in PubMed

on 9/12/2015

(n=36)

Record identified

through database

searching in ISI Web of

Science on 9/12/2015

(n=18)

Record identified

through database

searching in British

Nursing Index on

21/11/2015

(n=1)

↓ ↓ ↓

Scr

eenin

g

Records after duplicates removed

(n= 44)

↓

Records screened

(n= 6)

→ Records excluded

(n=38)

↓

Eli

gib

ilit

y

Full-text articles assessed for

eligibility

(n=5)

→ Full-text articles

excluded

(n=1)

Evaluating the usability

of an educational

pamphlet and video

↓

Incl

uded

Studies included in

qualitative synthesis

(n=5)

(Mocher et al., 2009)

47

Appendix D Table of Evidence

Citation / Design

(Study quality)

Sample

Characteristics

Intervention

Group

Control

Group

Outcome measure

(Assessment time)

Effect Size

(Intervention –Control)

Bustos, Jaaniste,

Salmon &

Champion (2008)

RCT (1+)

Parents of 6-

month-old

children for

immunization at

clinic

1. 40 mothers

(80%)

Pamphlet on

coping-promoting

behavior

N=30

Standard Care

N=32

1. Utilization

- CAMPIS-Rª

- Immediate before

vaccination

Immediate before vaccination 1. Mean of coping-promoting statements

= 2.32 (p<0.01)

Cohen et al. (2015)

RCT (1++)

Parents of 4- to

6-year-old

children for

immunization at

clinic

1. Mean age: 38yrs

2. 78 mothers

(86.7%)

10-minute

animated

computer training

program

N=30

Standard Care

N=30

1. Knowledge

- Parent Procedural Behavior

Test

- VASs

- Immediate post-vaccination

- Three months later

2. Utilization

- Behavioral coding scales*

Immediate post-vaccination 1. Mean of Reassuring =31.36 (p<0.05)

Mean of Providing information = 18.93 (p<0.05) Mean of Apologizing = 15.09 (p<0.05)

2. Mean of Distracting = 0.1 (p<0.05) Mean of Deep breathing = 0.02(p<0.05) Mean of Reassuring = -0.07(p<0.05) Three months later

1. Mean of Providing information = 13.65 (p<0.05) Mean of Apologizing = 15.76 (p<0.05)

Taddio et al.

(2014a)

Controlled before-

and-after study (1-)

Mothers just

given birth to

infants in

postnatal ward

1. Mean age

(I) 30-32 years

(C) 33 years

Black and white

pain management

pamphlet without

special attention

drawn to mothers

N=220

Standard Care

N=220

1. Knowledge

- Knowledge test

- After next vaccination

2. Utilization

- Self report

- After next vaccination

After next vaccination

1. Mean = 0.4 (p=0.115)

2. Mean =0.2 (p=0.935)

For mothers who had read the pamphlet

in invention site

1. Mean = 1.0 (p=0.023)

2. Mean = 0.2 (p=0.294)

48

CAMPIS-R: Child-Adult Medical Procedure Interaction Scale-Revised; VASs: Visual analog scale; (I): Intervention group; (C): Control group;

ªThe use of statements were recorded for 30 seconds before the vaccination

*Observation by video recording for the parents’ behavior 3 minutes before cleaning the skin till 3 minutes following removal of needle/ parents left treatment room

** Observation by video recording. Use of one or more evidence-based pain management strategy at the right time for optimal analgesia was recorded

For study done by Cohen et al. (2015), the intervention group is compared to the control group which is related to the research topic, the distraction only group was ignored

For study done by Taddio et al. (2014c), the whole intervention group (the pamphlet only group and pamphlet with pretest group) is compared to the whole control group

(control group and control with pretest group)

Taddio et al.

(2014c)

Solomon 4-group

RCT (1++)

Mothers just

given birth to

infants in

postnatal ward

1. Mean age

(I) 32.2 years

(C) 33.9 years

Pain management

pamphlet and

pain management

pamphlet with

pretest

N=60

Factsheet on

normal growth

and factsheet on

normal growth

with pretest

N=60

1. Knowledge

- Knowledge test

- Immediate post

intervention

- After next vaccination

2. Utilization

- Self-report

- After next vaccination

Immediate post-intervention

1. Mean = 5.9 (p<0.05)

After next vaccination

1. Mean = 0.2 (p=0.27)

2. Mean = 0.1 (p=0.89)

Taddio et al. (2015)

Cluster RCT(1++)

Parents of 2- or

4-month-old

infants for

immunization at

clinic

1. Mean Age:

(I) 33.2 years

(C) 32.8

Pain management

pamphlet, video

and poster

N= 80

Standard Care

N=80

1. Utilization

- Observation**

- Immediate post-vaccination

Immediate post-vaccination

1. Mean = 43 (p<0.001)

49

Appendix E

Checklist of SIGN

Bustos, T., Jaaniste, T., Salmon, K., & Champion, G. D. (2008). Evaluation of a brief parent

intervention teaching coping-promoting behavior for the infant immunization context: A randomized

controlled trial. Behavior Modification, 31(4), 450-467.

Section 1: Internal Validity

In a well conducted RCT study …

1.1 The study addresses an appropriate and

clearly focused question Yes

PICO is clearly stated

1.2 The assignment of subjects to treatment

groups is randomised Yes By computer-generated random

numbers table

1.3 An adequate concealment method is used Can’t say Outcome assessor is not

aware of the condition which the parent-

infant pairs are assigned but method of

concealment is not mentioned

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation Yes

Outcome assessor is kept blinded

1.5 The treatment and control groups are similar

at the start of the trial Can’t say Though there is no

significant different in terms of gender, age

and gestational age of the infants, the

characteristic of parents have not been

described adequately

1.6 The only difference between groups is the

treatment under investigation Yes The only difference between the

group is the recipient of information sheet

on coping-promoting behavior

1.7 All relevant outcomes are measured in a

standard, valid and reliable way Yes Parents’ behavior is coded by the

Child-Adult Medical Procedure Interaction

Scale-Revised.

1.8 What percentage of the individuals or

clusters recruited into each treatment arm of

the study dropped out before the study was

completed?

0%

1.9 All the subjects are analysed in the groups

to which they were randomly allocated

(often referred to as intention to treat

analysis)

No

No drop out

1.10 Where the study is carried out at more than

one site, results are comparable for all sites

Does not apply

Study is done in a clinic

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimise

bias?

Code as follows:

Acceptable (+)

2,2 Taking into account clinical considerations,

your evaluation of the methodology used,

and the statistical power of the study, are

you certain that the overall effect is due to

the study intervention?

Yes

The recruited sample is enough to detect a

significant effect

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

50

Cohen, L. L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E., McGrath, P.

J., & Cousins, L. A. (2015). Automated parent-training for pre-schooler immunization pain relief: A

randomized controlled trial. Journal of Pediatric Psychology, 40(5), 526-534.

Section 1: Internal Validity

In a well conducted RCT study …

1.1 The study addresses an appropriate and

clearly focused question Yes

PICO is clearly stated

1.2 The assignment of subjects to treatment

groups is randomised Yes By computer-generated random

number table

1.3 An adequate concealment method is used Yes Concealed in a binder and is only

revealed when the participants agree to join

the study

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation Yes Nurse who administers the

vaccine is blinded to the study

1.5 The treatment and control groups are similar

at the start of the trial Yes No significant difference in race,

gender, marital status, income, education

level and number of injections between the

groups

1.6 The only difference between groups is the

treatment under investigation Yes No other information regarding

pain relief measures is provided

1.7 All relevant outcomes are measured in a

standard, valid and reliable way Yes Visual analog scale, which is

commonly used in pediatric procedural

distress studies, is used for assessing

parental knowledge

Standardized behavioral coding scale is used

to code the parental and child behavior

during the procedure

1.8 What percentage of the individuals or

clusters recruited into each treatment arm of

the study dropped out before the study was

completed?

No No mention regarding the

participants drop out from the study at the

phase of follow up 90 days later after the

intervention

1.9 All the subjects are analysed in the groups

to which they were randomly allocated

(often referred to as intention to treat

analysis)

No

Follow up data are not included if the

participants cannot be reached at the 90 days

follow up

1.10 Where the study is carried out at more than

one site, results are comparable for all sites

Does not apply

In only one site

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++)

2,2 Taking into account clinical considerations,

your evaluation of the methodology used,

and the statistical power of the study, are

you certain that the overall effect is due to

the study intervention?

Yes. RCT is used to determine whether the

intervention is useful for parents in

engaging evidence-based pain relief

measure during preschoolers’ vaccination.

Sample size is carefully calculated based on

previous study. Enough participates are

recruited in each arm of the study. It is

certain that the overall effect is due to the

study intervention.

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

51

Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah, V. (2014a).

Impact of a parent-directed pamphlet about pain management during infant vaccinations on maternal

knowledge and behaviour. Neonatal Network, 33(2), 74-82.

Section 1: Internal Validity

In a well conducted RCT study …

1.1 The study addresses an appropriate and

clearly focused question Yes

PICO is clearly stated

1.2 The assignment of subjects to treatment

groups is randomised No

It is not a RCT

1.3 An adequate concealment method is used No It is not a RCT

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation. Yes Participants and outcome

assessors are blinded to the study.

1.5 The treatment and control groups are similar

at the start of the trial Yes No significant difference in the

marital status, education level and age of

mothers and the mode of delivery, maturity

and age of vaccination of infants between

control and intervention group

1.6 The only difference between groups is the

treatment under investigation Yes Various methods are used to

reduce the potential bias of the study. For

example, participants are not told the nature

of the research so to reduce the risk of

participants finding the information

regarding the research topic

1.7 All relevant outcomes are measured in a

standard, valid and reliable way. Yes Standardized survey and

knowledge test is used

1.8 What percentage of the individuals or

clusters recruited into each treatment arm of

the study dropped out before the study was

completed?

Overall = 19.5%

Intervention group = 18.2%

Control group = 20.9%

1.9 All the subjects are analysed in the groups

to which they were randomly allocated

(often referred to as intention to treat

analysis)

No

No ITT is mentioned

1.10 Where the study is carried out at more than

one site, results are comparable for all sites.

Yes No marked difference between

the intervention and external control sites in

terms of number of delivery per years, nurse

to mother-infant dyads ration, treatment

after delivery and knowledge and use of

pain management at the before

implementation phase

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimise

bias?

Code as follows:

Acceptable (+)

2,2 Taking into account clinical considerations,

your evaluation of the methodology used,

and the statistical power of the study, are

you certain that the overall effect is due to

the study intervention?

Yes. The authors minimize the bias of the

study by blinding the participants and

outcome assessors of the natural and using

valid standardized survey for assessing

participants’ knowledge. The rate of

response is also high.

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

52

Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V. (2014c). Teaching

parents to manage pain during infant immunizations. Laying the foundation for better pain

management practices. Clin J Pain, 30(11), 987-994.

Section 1: Internal Validity

In a well conducted RCT study …

1.1 The study addresses an appropriate and

clearly focused question Yes

PICO is clearly addressed

1.2 The assignment of subjects to treatment

groups is randomised Yes By off-site computer random

numbers table.

1.3 An adequate concealment method is used Yes By sequentially numbered

opaque sealed envelopes

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation. Yes Outcome assessor who

conducted the interview is kept blinded

1.5 The treatment and control groups are similar

at the start of the trial Yes No significant difference in the

maternal age, parity, marital status and

maternal feeling towards immunization,

gestational age, mode of delivery and birth

weight of infants between the four groups.

1.6 The only difference between groups is the

treatment under investigation Yes No important differences

between the control and intervention groups.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way Yes Outcome measures are clearly

stated as knowledge test with 5-point Likert

scale. The knowledge test has been used to

assess knowledge of mothers in previous

study. For answer in the knowledge to be

scored, participants need to answer the

question correctly with indication of “very

sure” to that answer.

1.8 What percentage of the individuals or

clusters recruited into each treatment arm of

the study dropped out before the study was

completed?

Overall = 31.7%

Intervention group = 26.7%

Control group = 35%

1.9 All the subjects are analysed in the groups

to which they were randomly allocated

(often referred to as intention to treat

analysis)

Yes

ITT is used

1.10 Where the study is carried out at more than

one site, results are comparable for all sites.

Does not apply

The study is taken place at a perinatal

hospital in Canada

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++)

2,2 Taking into account clinical considerations,

your evaluation of the methodology used,

and the statistical power of the study, are

you certain that the overall effect is due to

the study intervention?

Yes. Rigorous randomised controlled trial

and validated outcome measurements are

used. Through 31.7% of participants drop

out from the study, there is no significantly

difference in the characteristics between

those who can be contacted and those who

cannot. Nonresponse bias dose not affect the

observed results on follow up.

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

53

Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H., Habtom, E., Ilersich, A. F., Riddell, R. P., &

Shah, V. (2015). Impact of parent-directed education on parental use of pain treatments during

routine infant vaccinations: a cluster randomized trial. Pain, 156(1), 185-191.

Section 1: Internal Validity

In a well conducted RCT study …

1.1 The study addresses an appropriate and

clearly focused question Yes

PICO is clearly addressed

1.2 The assignment of subjects to treatment

groups is randomised Yes By off-site computer random

number generator

1.3 An adequate concealment method is used Yes It is a cluster RCT

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation Yes Participants and outcome

assessors are kept blinded

1.5 The treatment and control groups are similar

at the start of the trial Yes No statistically significant

differences between the intervention and

control groups in terms of maternal

characteristics, ethnicity, parity and number

of children of participants and infant

characteristics

1.6 The only difference between groups is the

treatment under investigation Yes Standardized study procedures

are used to minimize bias as nurses who

administering vaccine work in multiple

clinics

1.7 All relevant outcomes are measured in a

standard, valid and reliable way Yes Numerical rating scale, Modified

Behavioral Pain Scale and crying duration

are used as outcomes measures

1.8 What percentage of the individuals or

clusters recruited into each treatment arm of

the study dropped out before the study was

completed?

Overall = 21.3%

Intervention group = 25%

Control group = 14%

1.9 All the subjects are analysed in the groups

to which they were randomly allocated

(often referred to as intention to treat

analysis)

Can’t say

Modified intention-to-treat is used without

explanation

1.10 Where the study is carried out at more than

one site, results are comparable for all sites.

Yes No difference between the sites in

terms of usual practice of vaccination

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++)

2.2 Taking into account clinical considerations,

your evaluation of the methodology used,

and the statistical power of the study, are

you certain that the overall effect is due to

the study intervention?

Yes. Cluster randomization design is used to

minimize bias. Standardized study

procedures and data collection method are

used to minimize contamination between the

intervention and control groups. Though

21.3% of drop-out rate is observed, it is

typical in the study setting as the study

setting is a temporary measure after infant

birth. It is also common a high drop out rate

observed in studies conducted over a long

period of time. So the authors account for

10% loss during calculating the sample size

to increase the number of participants in

order to reduce the bias of the study.

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

54

Appendix F

Time Schedule for Implementation Process of the Innovation

Task Month 1 2 3 4 5 6 7 8 9 10 11 12

Preparation of proposal & guideline by working group

Approval of proposal by the administrative level of DH

Preparation of equipment

Staff training

Pilot testing, evaluation of pilot test and refining guideline

Formal implementation of innovation

Data analysis and evaluation

55

Appendix G

Content of the Pamphlet and Video

A) Pharmacological Strategies

i) Sugar Water

Give baby sugar water to drink right before the injection

Prepare sugar water by mixing 1 teaspoon of sugar with 2 teaspoons of water

B) Physical Strategies

i) Hold Upright

Hold baby close during injection, in a hug or on your lap.

ii) Breastfeeding

Breastfeed baby before, during and after injection

If baby cannot be breastfeed, offer a bottle or pacifier instead

C) Psychological Strategies

i) Deep Breathing

Breath so the stomach expands, not the chest

For parents

Stay calm and deep breath. This helps your child stay calm as he/ she looks to parents

for how to act and feel

If parents are nervous, take a few slow deep breaths to calm yourself down before and

during the injection

For child 3 years old or above

Teach child how to breath slow and deep

ii) Distraction

Methods which keep baby’s attention away from the injection:

Rocking, cuddling, singing, sucking (breastfeeding or pacifier), toys

Coping-promoting talk

a) Humor or Praise

“This is a Super Baby’s job”

b) Non-procedural Talk

“We’re going to watch movie later on”

c) Prompt to use a coping strategy

“Look at Mami/ Daddy”

(Bustos et al.,2008; Cohen et al. (2015); Taddio et al., 2014a;

Taddio et al., 2014c; Taddio et al. ,2015)

56

Appendix H

Costs of the Innovation

Material Cost per 1000 subjects

Item Budget Estimation

(HKD)

Cost

(HKD)

Guideline for Nurses ( 3 pages) $0.5/page x 3 x 1000 $1500

Education pamphlet(1 page) $0.5/page x 1 x 1000 $500

Evaluation form (1 page) $0.5/page x1 x 1000 $500

Video production $11000 $11000

DVD production (2 copies) $20/copy x 2 $40

Subtotal $13540

Non material cost per 1000 subjects

Additional time for brief introduction of

pamphlet (2 minute)

$185 x 2 /60 x 1000 $6167

Subtotal $6167

Grand total $19707

The mean monthly salary of registered nurse in DH at Master Pay Scale point 19 is

$32560 per month. Having to work 44 hours per week and 4 weeks per month, the

hourly salary for registered nurse in MCHC is $32560/44/4 = $185 per hour (Civil

Service Bureau, 2015)

57

Appendix I

Cost of Not Implementing the Innovation

Non material cost per 20 repeated visit

Item Budget Estimation (HKD) Cost (HKD)

Nurse interview (20 minutes) $185 x 25/60 x20 $1542

Vaccination (5 minutes)

Grand Total $1542

2% of parents prefer spread immunization into two separate visit. For each 1000

children, there are 20 children revisit the designated MCHC for immunization

The mean monthly salary of registered nurse in DH at Master Pay Scale point 19 is

$32560 per month. Having to work 44 hours per week and 4 weeks per month, the

hourly salary for registered nurse in MCHC is $32560/44/4 = $185 per hour (Civil

Service Bureau, 2015)

58

Appendix J

Grades of Recommendations

Grade Statements

A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating

overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall

consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency

of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2++

(Scottish Intercollegiate Guidelines Network, 2014)

59

Appendix K

Evidence-based Practice Guideline

Background: Immunization is the most effective way in controlling, reducing and

eliminating infectious disease. However, immunization-induced pain leads to distress

to children, parents and health care provider, including needle phobia, nonadherence

to immunization schedule and conflict between parents and health care provider.

Through lots of scientifically proven pain management available, they are seldom

used as parents do not know them.

Clinical issue: To educate parents regarding the scientifically proven pain

management in order to empower parents managing immunization-induced pain

Title: An evidence-based parent-directed education program

Target users: All nurses responsible for interviewing parents before childhood

immunization in MCHC

Target group: Parents of children below 6 years old receiving immunization in

MCHC

Aim: To increase parents’ knowledge and utilization of scientifically proven pain

management during childhood immunization

Objectives:

1) To summarize the best available evidence on parental educational intervention

regarding pain management during childhood immunization.

2) To formulate clinical guideline in educating parents regarding pain management

strategy based on the best available evidence.

3) To standardize the process of educating parents regarding pain management

during childhood immunization in MCHC.

Evidence based recommendations

Recommendation 1

The education intervention should be delivered on the day of childhood

immunization.

(Grade of Recommendations: A)

Available evidence

a. Offering training program when parents and children were waiting for

immunization successfully increased the parental awareness of the downside of

undesirable parent procedural behaviors (Cohen et al., 2015). (1++)

b. There was acute knowledge gain in evidence-based pain management immediately

after reading the factsheet (Taddio et al., 2014c). (1++)

c. The use of pain interventions by parents increased on the day of education (Taddio

et al., 2015). (1++)

60

Recommendation 2

Parents should be directed to read or watch the education materials.

(Grade of Recommendation: B)

Available evidence

a. The impact of an instructional pamphlet was low when it was passively distributed

to the target population and without attention was drawn on it. However, the

impact of the pamphlet on knowledge gain and utilization of effective pain

management intervention would be significant if the target population had read it

(Taddio et al., 2014a). (1-)

b. Reminder was given to the research participants to review the educational material

before childhood immunization with significant increase in the use of evidence-

based pain management (Bustos et al., 2008; Taddio et al., 2015). (1+; 1++)

Recommendation 3

One-page pamphlet with picture and word description should be disturbed to parents.

(Grade of Recommendation: B)

a. A simple, low-cost printed material was feasible and useful to educate and change

the behavior of a wide range of audience and the impact to the workload of staff

was low (Bustos et al., 2008; Taddio et al., 2014a; Taddio et al., 2014c) (1+; 1-;

1++)

Recommendation 4

Ensuring parents do not miss the important message from the pain management video

by gathering parents to watch the video in the function room before vaccination.

(Grade of Recommendation: A)

a. Method engaging parents to watch the whole video ensured them do not miss the

relevant content (Cohen et al., 2015; Taddio et al., 2015). (1++; 1++)

Recommendation 5

Incorporating both pamphlet and video on the day of immunization.

(Grade of Recommendation: A)

a. Implementing both pamphlet and video in outpatient clinic significantly increased

the use of pain management by parents during childhood immunization (Taddio et

al., 2015). (1++)

61

Reference of Guideline:

Bustos, T., Jaaniste, T., Salmon, K., & Champion, G. D. (2008). Evaluation of a brief

parent intervention teaching coping-promoting behavior for the infant

immunization context: A randomized controlled trial. Behavior Modification,

32(4), 450-467.

Cohen, L. L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E.,

McGrath, P. J., & Cousins, L. A. (2015). Automated parent-training for

preschooler immunization pain relief: A randomized controlled trial. Journal of

Pediatric Psychology, 40(5), 526-534. doi: 10.1093/jpepsy/jsu162

Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah,

V. (2014a). Impact of a parent-directed pamphlet about pain management during

infant vaccinations on maternal knowledge and behaviour. Neonatal Network,

33(2), 74-82.

Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V.

(2014c). Teaching parents to manage pain during infant immunizations. Laying

the foundation for better pain management practices. Clin J Pain, 30(11), 987-

994.

Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H., Habtom, E., Ilersich, A. F.,

Riddell, R. P., & Shah, V. (2015). Impact of parent-directed education on parental

use of pain treatments during routine infant vaccinations: a cluster randomized

trial. Pain, 156(1), 185-191.

62

Appendix L

Knowledge Test

Please circle the correct answer

Answer Correct

Answer

(will not be

shown)

1. Giving sugar water can reduce pain and distress T/F True

2. Using medicines like acetaminophen (Tylenol,

Tempra), or ibuprofen (Advil, Motrin) can reduce pain

and distress

T/F False

3. Putting ice on the skin can reduce pain and distress T/F False

4. Breastfeeding can reduce pain and distress T/F True

5. Bottle feeding can reduce pain and distress T/F True

6. Holding the baby can reduce pain and distress T/F True

7. Distracting the baby can reduce pain and distress T/F True

8. Acting calm can reduce pain and distress T/F True

9. Rubbing the skin can reduce pain and distress T/F False

(Taddio et al., 2014a ; Taddio et al., 2014c)

63

Appendix M

Observation Form of Parental use of Scientifically Proven Pain Management

during childhood immunization

Scientifically proven

pain management

Timing Tick whenever

appropriate

Sugar Water Before injection

Breastfeeding Before injection

During injection

Bottle feeding Before injection

During injection

Holding Before injection

During injection

64

Appendix N

Self-developed Satisfactory Questionnaire

Please put a tick in the appropriate boxes below to indicate your view on the following statements:

Strongly

Agree

Agree

Neutral

Disagree

Strongly

Disagree

Content of video is clear, concise and precise

Content of pamphlet is clear, concise and precise

I understand more regarding evidence based pain management during

childhood immunization

I feel more confidence to manage child’s pain during immunization after

watching the video and/or reading the pamphlet

Nurses are supportive in the way of using evidence based pain management

during childhood immunization

The innovation meets my need

Additional comment:

65

Appendix O

Outline of the Semi-structured Meeting

Aim: Providing opportunity for frontline nurses to express feeling and opinion

regarding the innovation

Participants: All front line nurses

Discussion point

1. Impact of the innovation in daily work (positively and negatively)

2. Difficulties encountered during interview and immunization process (Can they

be solved? Whether nurses have control over the implementation?)

3. Suggestion for improvement

4. Other opinion

66

Reference

Bustos, T., Jaaniste, T., Salmon, K., & Champion, G.D. (2008). Evaluation of a brief

parent intervention teaching coping-promoting behaviour for the infant

immunization context: A randomized controlled trial. Behavior Modification,

31(4), 450-467.

Centers for Disease Control and Prevention (2012). Introduction to program

evaluation for public health programs: A self-study guide. Retrieved May 2,

2016 from http://www.cdc.gov/eval/guide/step1/

Centre for Health Protection (2010, April). Child health survey 2005-2006. Retrieved

October 17, 2015, from the World Wide Web:

http://www.chp.gov.hk/files/pdf/chs_eng.pdf

Civil Service Bureau (2015). Master Pay Scale. Retrieved February 10, 2016 from

http://www.csb.gov.hk/english/admin/pay/42.html

Cohen, L., Rodrigues, N. P., Lim, C. S., Bearden, D. J., Welkom, J. S., Joffe, N. E., …

Cousins, L. A. (2015). Automated parent-training for pre-schooler immunization

pain relief: A randomized controlled trial. Journal of Pediatric Psychology,

40(5), 526-534.

67

Department of Health (2015, September 30). Department of Health annual report

2011/2012. Retrieved October 17, 2015, from the World Wide Web

http://www.dh.gov.hk/english/pub_rec/pub_rec_ar/pub_rec_arpis_1112_html.htm

l

Family Health Service (2013). 80th anniversary of Family Health Service, Department

of Health. The Government of the Hong Kong Special Administrative Region:

Department of Health. Retrieved October 24, 2015, from the World Wide Web

http://www.fhs.gov.hk/english/archive/files/reports/DH_booklet_18-7-2013.pdf

Family Health Service (2014, February 24). Child Health. Retrieved October 17,

2015, from the World Wide Web:

http://www.fhs.gov.hk/english/main_ser/child_health/child_health.html

Government of Canada (2015). Immunize your child. Retrieved January 24, 2016

from http://healthycanadians.gc.ca/healthy-living-vie-saine/immunization-

immunisation/children-enfants/immunize-immuniser-eng.php#s5

Hodges, B. C., & Videto, D. M. (2011). Assessment and planning in health programs

(2nd ed.). Sudbury, MA: Jones & Bartlett Learning.

Koperski, M. (1989). Health education using video recordings in a general practice

waiting area: an evaluation. Journal of the Royal College of General

Practitioner, 39, 328-330.

68

Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., The PRISMA Group (2009).

Preferred reporting items for systematic reviews and meta analyses: The

PRISMA Statement. PLoS Med 6(6): e1000097.

doi:10.1371/journal.pmed1000097

Parvez, E., Stinson, J., Boon, H., Goldman, J., Shah, V., & Taddio, A. (2010).

Mothers’ beliefs about analgesia during childhood immunization. Paediatr Child

Health, 15(5), 289-293.

Polit, D. F., & Beck, C. T. (2012). Nursing research: Evidence for nursing practice

(9th

ed.). Philadelphia, PA: Lippincott Williams & Wilkins.

Primary Care Office (2015, June 8). Hong Kong Reference Framework for Preventive

Care for Children in Primary Care Setting. Retrieved October 18, 2015, from the

World Wide Web

http://www.pco.gov.hk/english/resource/professionals_preventive_children_pdf.h

tm

Schechter, N. L., Zempsky, W. T., Cohen, L. L., McGrath, P. J., McMurtry, C. M., &

Bright, N. S. (2007). Pain reduction during pediatric immunizations: evidence-

based review and recommendations. Pediatrics, 119(5), e1184-e1198.

Doi:10.1542/peds.2006-1107

69

Scottish Intercollegiate Guidelines Network (2012, May). Methodology checklist 2:

Controlled trials. Retrieved December 14, 2015, from

http://www.sign.ac.uk/methodology/checklists.html

Scottish Intercollegiate Guidelines Network (2014, October). SIGN 50: A guideline

developer’s handbook. Retrieved December 14, 2015 from

http://www.sign.ac.uk/pdf/sign50.pdf

Stalker, C., & Elander, J. (2015). Effects of a pain self-management intervention

combining written and video elements on high-related quality of life among

people with different level of eduvation. Journal of Pain Research, 8, 581-590.

Taddio, A., Chambers, C. T., Halperin, S. A., Ipp, M., Lockett, D., Rieder, M. J., &

Shah, V. (2009). Inadequate pain management during rountine childhood

immunizations: The nerve of it. Clinical Therapeutics, 31(Supplement B), S152-

S167.

Taddio, A., Ipp, M., Vyas, C., Parikh, C., Smart, S., Thivakaran, S., … Shah, V.

(2014c). Teaching parents to manage pain during infant immunizations. Laying

the foundation for better pain management practices. Clin J Pain, 30(11), 987-

994.

70

Taddio, A., MacDonald, N. E., Smart, S., Parikh, C., Allen, V., Halperin, B., & Shah,

V. (2014a). Impact of a parent-directed pamphlet about pain management during

infant vaccinations on maternal knowledge and behaviour. Neonatal Network,

33(2), 74-82.

Taddio, A., Manley, J., Potash, L., Ipp, M., Sgro, M., & Vibhuti, S. (2007). Routine

immunization practices: use of topical anethetic and oral analgesic. Pediatrics,

120(3), e637-643. DOI: 10.1542/peds 2006-3351.

Taddio, A., Parikh, C., Yoon, E. W., Sgro, M., Singh, H. Habtom, E., Ilersich, A. F.,

Riddell, R. P., & Shah, V. (2015). Impact of parent-directed education on parental

use of pain treatments during routine infant vaccinations: A cluster randomized

trial. Pain, 156(1), 185-191.

Taddio, A., Shah, V., Leung, E., Wang, J., Parikh, C., Smart, S., Hetherington, R., Ipp,

M., Riddell, R. P., Sgro, M. Jovicic, A., & Franck, L. (2013). Knowledge

translation of the HELPinKIDS clinical practice guideline for managing

childhood vaccination pain: usability and knowledge uptake of educational

materials directed to new parents. BMC Pediatrics, 13(23).

Taddio, A., Smart, S., Sheedy, M., Yoan, E. W., Vyas, C., Parikh, C., Riddell, R. P., &

Shah, V. (2014b). Impact of prenatal education on maternal utilization of

analgesic interventions at future infant vaccinations: a cluster randomized trial.

Pain, 155, 1288-1292.

71

Tuong, W., Larsen, E. R., & Armstrong, A. W. (2014). Video to influence: a

systematic review of effectiveness of video-based education in modifying health

behaviors. J Behav Med, 37, 218-233.

Wallace, A. S., Mantel, C., Mayers, G., Mansoor, O., Gindler, J. S., & Hyde, T. B.

(2014). Experiences with provider and parental attitudes and practices regarding

the administration of multiple injections during infant vaccination visits: Lessons

for vaccine introduction. Vaccine, 32, 5302-5310.

Waston J. (1985). Nursing the philosophy and science of caring. Boulder, Colorado:

University Press of Colorado.

Woodin, K. A., Rodewald, L. E., Humiston, S. G., Carges, M. S., Shcaffer, S. J., &

Szilagyi, P. G. (1995). Physician and parent opinions. Are children becoming

pincushions from immunizations? Arch Pediatr Adolesc Med, 149, 845-849.

World Health Organization (2013). Global vaccine action plan 2011-2020. The USA:

WHO Press. Retrieved October 15, 2015 from the World Wide Web:

http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011

_2020/en/

World Health Organization, Regional Office for Eastern Mediterranean (2013). Health

education: theoretical concepts, effective strategies, and core competencies.

Cario, Egypt: Author.