RESEARCH PROTOCOL

A randomized controlled trial of the effectiveness of a therapeutic

play intervention on outcomes of children undergoing inpatient
elective surgery: study protocol
Hong Gu He, Lixia Zhu, Ho Cheung William Li, Wenru Wang, Katri Vehvilainen-Julkunen &
Sally Wai Chi Chan
Accepted for publication 27 July 2013

Correspondence to H.G. He:

e-mail: nurhhg@nus.edu.sg
Hong Gu He MD PhD RN
Assistant Professor
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore
Lixia Zhu PhD RN
Research Assistant and Project Manager
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore
Ho Cheung William Li PhD RN
Assistant Professor
School of Nursing, The University of Hong
Kong, China
Wenru Wang PhD RN
Assistant Professor
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore
Katri Vehvil
ainen-Julkunen PhD RN MW
Professor
Department of Nursing Science, Faculty of
Health Sciences, University of Eastern
Finland, Kuopio, Finland
Sally Wai Chi Chan PhD RN
Professor
Alice Lee Centre for Nursing Studies, Yong
Loo Lin School of Medicine, National
University of Singapore, Singapore

2013 John Wiley & Sons Ltd

NEN-JULKUNEN K & CHAN

H E H . G . , Z H U L , L I H C W , W A N G W , V E H V I L AI
S . W . C ( 2 0 1 4 ) A randomized controlled trial of the effectiveness of a therapeutic
play intervention on outcomes of children undergoing inpatient elective surgery:
study protocol. Journal of Advanced Nursing 70(2), 431442.
doi: 10.1111/jan.12234

Abstract
Aim. To report a trial protocol to determine if a therapeutic play intervention
leads to significant reduction in perioperative anxiety, negative emotional
manifestations and postoperative pain of children undergoing inpatient elective
surgery and in their parents perioperative anxiety.
Background. Children undergoing surgery often experience anxiety, exhibit
negative emotional manifestations pre-operatively and postoperative pain. Previous
studies report that therapeutic play intervention has positive effects on anxiety
reduction, while few studies have examined the effects of such intervention on
children undergoing major elective surgery.
Design. Randomized controlled trial with repeated measures is proposed.
Methods. This study will recruit 106 pairs of 614-year-old children undergoing
elective surgery in a Singaporean public hospital and their parents (protocol
approved in October 2011). Eligible participants will be randomly allocated to
either a control group (receiving routine care) or an experimental group (receiving
1-hour therapeutic play intervention plus routine care). Outcome measures include
childrens anxiety, emotional manifestation and postoperative pain, their parents
anxiety and process evaluation. Data will be collected at baseline (37 days before
the operation), on the day of surgery and around 24 hours after the surgery.
Discussion. This study will identify a clinically useful and potentially effective
approach to prepare children for surgery by reducing anxiety of both children
and their parents during the perioperative period. The reduction of anxiety may
lead to reduction of postoperative pain, which will eventually improve the
physical and psychological well-being of children. This study was funded by the
National Medical Research Council in Singapore.
Keywords: anxiety, children, emotional manifestation, nursing, postoperative
pain, therapeutic play intervention
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H.G. He et al.

Why is this research or review needed?

Children undergoing surgery often experience significant stress
and anxiety, which affect their ability to cope with surgery,
hinder them from cooperating with healthcare providers and
inhibit their postoperative recovery.

Previous studies report that therapeutic play intervention has

anxiety when their children undergo surgery (Hug et al.

2005). A childs level of anxiety is positively and significantly correlated with his/her parents level of anxiety
(LaMontagne et al. 2001, Li & Lam 2003). Thus, intervention to reduce both children and their parents anxiety level
and help them cope with the stress of surgery is necessary
and important.

positive effects on anxiety reduction, while few studies have

examined the effects of such intervention on children undergoing major elective surgery.

What are the key findings?

This is the first randomized controlled trial examining the
effectiveness of therapeutic play on school-age childrens perioperative anxiety, pre-operative negative emotional behaviours and postoperative pain as well as their parents anxiety.

This study has developed a standardized therapeutic play

intervention protocol and detailed study procedure, which
provide the possibility for other researchers to duplicate the
study in other countries.

How should the findings be used to influence policy/

practice/research/education?
To provide evidence of a clinically useful and potentially
effective approach, therapeutic play intervention, to prepare
children for surgery by reducing the perioperative anxiety of
both children and their parents.

It is necessary to determine the benefits of therapeutic play, in

terms of both human outcomes and economics, before recommending it as a suitable approach to be used in the health service.

Introduction
Children undergoing inpatient elective surgeries commonly
experience significant stress and anxiety (Li & Lam 2003,
Justus et al. 2006, Kain et al. 2006, Li et al. 2007b). Excessive anxiety affects childrens ability to cope with surgery,
hinders them from cooperating with healthcare providers
and inhibits their postoperative recovery (Lizasoain & Polaino 1995, Becher & Sing 1997). Children exhibit negative
emotional behaviours such as crying and verbal protest
during anaesthesia induction when they are anxious
(Kain et al. 1996, Justus et al. 2006). Postoperative pain
is another common symptom experienced by children
undergoing surgery. Pain and anxiety are intrinsically
related and they have superimposed effects on each other
(Gillies 1993, Kain et al. 2006, Vaughn et al. 2007, Chieng
et al. 2013a,b). Parents also face a considerable amount of
432

Background
Surgery can be a very stressful experience for children in
that it can have a profound effect on both children and
their parents (OConner-Von 2000, Li & Lam 2003, Spencer & Franck 2005). Among numerous negative responses
induced by surgery, anxiety is most prominent in children
(Li & Lopez 2004a). Kain et al. (2006) reported that there
were more than five million cases of paediatric surgery
annually in the USA and up to 50% of them develop preoperative anxiety. Excessive pre-operative anxiety can affect
their physical and psychological health, hinder their ability
to cope with surgery, display negative behaviour and inhibit
their postoperative recovery (Lizasoain & Polaino 1995, Becher & Sing 1997). Children who are more anxious preoperatively are less cooperative (Li & Lopez 2005b) and
consume more analgesics during their hospitalization and
also exhibit more emotional disturbances (Kain et al.
2006).
Postoperative pain management in children has been a
challenge (Hamers & Abu-Saad 2002, Li & Lam 2003,
Twycross 2007). Previous studies suggest that childrens
postoperative pain is often poorly managed (He et al. 2007,
Sutters et al. 2007, Twycross 2007). Walding (1991) has
highlighted that both pain and anxiety work by a similar
mechanism. When a child is anxious, there is an increase in
the sympathetic responses to pain stimuli thus making them
more aware of the pain signal (Arntz et al. 1994). This
increase in awareness of pain will reduce pain thresholds,
therefore increasing the pain experienced (Linton & Linton
2005). Previous studies have also reported that pain and
anxiety are interrelated and they have the ability to influence each other (Gillies 1993, LaMontagne et al. 2001,
Kain et al. 2006, Vaughn et al. 2007).
Apart from children, parents also experience anxiety,
stress and feelings of helplessness when their children
undergo surgery (Hug et al. 2005, Li et al. 2007b). Scrimin
et al. (2009) suggested that pre-operative anxiety level is
significantly higher in parents whose children undergo
major surgery compared with those whose children undergo
day surgery. Childrens anxiety level is positively correlated
with their parents anxiety level (LaMontagne et al. 2001,
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Li & Lam 2003). Children of highly anxious parents are

often more frightened, anxious or uncooperative after surgery. This suggests that parents anxiety has an impact on
their childrens pre-operative anxiety (LaMontagne et al.
2001).
Nurses play a vital role in helping children to cope with
the stress of surgery (Broome 1990, Ziegler & Prior 1994).
However, pre-operative psychological preparation for children remains inadequate (OConner-Von 2000). During the
past decade, there has been an increase in the use of therapeutic play intervention to help children cope with the
stress of hospitalization. Erickson (1958), a pioneer in the
study of therapeutic play with hospitalized children, demonstrated the benefits of using play intervention and dolls to
prepare preschool hospitalized children for intrusive medical procedures. Since then, numerous case studies have
described the benefits of therapeutic play in hospitalized
children (Armstrong 2000, OConnor & Drennan 2003,
Wang & Lo 2006, Li & Lopez 2008), especially for those
who receive medically invasive procedures (Wolfer & Visintainer 1975). Zahr (1998) found that preschool children
who received therapeutic play interventions pre-operatively
were significantly calmer, reported lower mean blood
pressures and pulse rates, took less time to void and experienced fewer adverse behavioural changes postoperatively,
than those who received routine care. Li et al. (2007a)
reported that therapeutic play can reduce pre-operative and
postoperative state anxiety with school-age children who
undergo minor day surgery. However, childrens postoperative pain was similar whether they received therapeutic play
intervention or not (Li et al. 2007a). Li et al.s study did
not control the effects of types of surgery on childrens outcomes. Different types of surgery involving different body
organ systems may have very different impacts on children
with regard to their anxiety, emotional responses and postoperative pain. Since 1996, therapeutic play has been used
to prepare children for medical procedures such as intravenous infusion, blood drawing and surgery in a hospital in
Singapore (Woon 2004). However, the outcomes of therapeutic play have not been well evaluated.
Most previous studies of therapeutic play were conducted
with preschool children who received medically invasive
procedures and only a few with school-age children who
received minor day surgery. The benefits of therapeutic play
for school-age and older children and for those who receive
elective major and more invasive surgery remain unknown.
In addition, most of the studies are conducted in western
countries (Armstrong 2000, OConnor & Drennan 2003)
with limited studies in Asian regions (Li et al. 2007a) and
none in Singapore. Anxiety and pain are both subjective
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Study protocol of therapeutic play for children

experiences and people of different cultural backgrounds

might experience them differently. There is an imperative
need for more rigorous empirical scrutiny of the effectiveness of therapeutic play in preparing children for elective
major surgery.
Theoretical framework of the study
This study will be guided by the theoretical framework
based on Lazarus and Folkmans (1984) theory of cognitive
appraisal, psychological stress and coping. Stress is a
dynamic state of mind that is determined by the ongoing
relationship between a person and a stimulus that is perceived as threatening (Lazarus & Folkman 1984). The way
individuals cope with stress is dependent on how they
appraise it. Based on the theory, a person evaluates stress,
determines its significance and evaluates the resources
available to deal with a stressful situation. The coping
behaviours will lessen the impact of the event or make the
event more tolerable (Lazarus & Folkman 1984). Paediatric
surgical patients are surrounded by stressful events, which
subsequently cause pre-operative anxiety. Lazarus and
Folkman (1984) postulated that individuals evaluation of
stress is influenced by their perception of control over a
potential threat. Our study reasoned that if children are
able to have adequate control over their upcoming surgery,
they will perceive less threat and manifest less anxiety.
Therefore, the primary goal of the use of therapeutic play
intervention is to assist children in regaining their sense of
control to alleviate their perioperative anxiety.
Lazarus and Folkman (1984) conceptualized coping as
consisting of both problem- and emotional-focused coping.
Problem-focused coping aims to modify, avoid or minimize
the impact of the stress encountered or is an attempt to control the situation. Emotional-focused coping is based on the
elimination of undesirable emotions that result from the
stress experience. Our therapeutic play intervention aims to
facilitate both problem- and emotional-focused coping skills
of children. First, strategies facilitating childrens problemfocused coping skills included the procedural and sensory
information provided through the use of videos and photos
of the actual operating theatre environment and doll demonstration of the use of equipments, such as blood pressure
machine and anaesthesia mask. Hence, this would help
children cope or eliminate their fear of loss of control over
the upcoming surgery, unfamiliar environment and fear of
the unknown. Second, strategies facilitating childrens
emotional-focused coping skills included childrens return
demonstration of anaesthesia induction, when they could
express anxiety and act out their fear of pain and the unpleasant experiences they perceive of anaesthesia induction.
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H.G. He et al.

Childrens ability to cope with stress would, in turn,

reduce their perioperative anxiety. Parents who participate
in the therapeutic play intervention would also be able to
enhance their problem-focused coping through procedural
and sensory information provided and hence reduce their
perioperative anxiety and also, in turn, reduce their childs
perioperative anxiety (Li & Lam 2003). Eventually,
childrens postoperative pain is expected to be reduced
through the reduction of perioperative anxiety (Kain et al.
2006). Figure 1 outlines the theoretical framework of this
study.

Hypotheses

The study

Aim
This study aims to determine the effectiveness of the therapeutic play intervention on outcomes (perioperative anxiety,
emotional manifestations and postoperative pain) of children undergoing inpatient elective surgery and their parents
(perioperative anxiety).

Objectives

To determine the effectiveness of the therapeutic play

intervention on childrens perioperative anxiety, emotional manifestations before the anaesthesia induction
and postoperative pain, as well as their parents perioperative anxiety.
To determine the correlation among childrens perioperative anxiety, emotional manifestation and postoperative pain and between childrens and their parents
anxiety level.

To explore children and their parents opinion on the

benefits of the intervention and suggestions for
improvement.

Children in the experimental group will report

significantly lower levels of pre- and postoperative anxiety, fewer negative emotion manifestations before the
anaesthesia induction and less postoperative pain than
those in the control group.
Parents with a child in the experimental group will report
significantly lower levels of anxiety (before and after
their childs operation) than those in the control group.
There will be significantly positive correlation among
childrens anxiety level, emotional manifestation and
postoperative pain.
There will be significantly positive correlation between
childrens and their parents anxiety level.

Design/Methodology
A randomized controlled trial with repeated measures study
design will be used. Eligible participants will be randomly
assigned into either a control group (receiving routine care)
or an experimental group (receiving 1-hour therapeutic play
intervention plus routine care) by the Research Randomizer
(2010). A single-blind technique will be adopted, where a
research assistant, who will be responsible for data collection (e.g. observation of emotional behaviours by Childrens
Emotional Manifestation Scale), will be not aware of the
treatment allocation of the participants. Both outcome and
process evaluation will be conducted.

Therapeutic play intervention

Problem-focused coping
Procedural and sensory information
Through virtual tour of OT and doll
demonstration

Fear of unknown
Fear of environment
Fear of loss of control

Parents perioperative anxiety

Emotional-focused coping
Help act out unpleasant feelings through
return demonstration

Stress

Fear of pain
Fear of unpleasant experiences

Childrens perioperative anxiety

Childrens postoperative pain

Figure 1 Theoretical framework of this

study.

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Participants
Participants will be recruited from a public hospital in Singapore. The inclusion criteria for children include: (1) age
between 614 years; (2) undergoing an inpatient elective surgery; (3) ability to communicate verbally and be literate in
either English or Chinese; and (4) being accompanied by their
parents (either mother or father or both) during the perioperative period. The exclusion criteria for children include: (1)
having past experience of surgery; (2) having cognitive and
learning disabilities identified from their medical records; and
(3) having a long-term illness and/or pain that requires special medical care. The inclusion criteria for parents include:
(1) main caregiver of the child who meets the inclusion criteria; and (2) ability to communicate verbally and be literate in
either English or Chinese. The exclusion criteria for parents
are (1) guardians of the child; and (2) those who have past
experiences of their child undergoing surgery.
Sample size determination
Sample size calculation is based on the expected differences
between groups from a previous similar study (Li et al.
2007a), which suggests (0.60) effect sizes. In this study, a
repeated measures analysis of covariance will be used to
test for differences between (two groups), within (3 time
points) and interaction (group 9 time) effects. We expect a
medium effect size (0.60), the required sample for each
group will be around 44 (total = 88) and this can achieve
80% power at a 5% level of significance (two-tailed)
(Hintze 2007). Taking into consideration 20% dropout rate
in this study, the total sample size will be 106 pairs of children and their parents (53 pairs in each group).
Regarding the process evaluation, a purposive sample
(n = 15) from the experimental group, which indicates different levels of outcomes, will be selected to participate in a
semi-structured interview. Children with significant positive
changes in pre- and postanxiety levels (n = 5), those without significant changes (n = 5) and those with negative
changes (n = 5) in anxiety levels will be invited to participate in the interview together with their parents to obtain
their opinions about the therapeutic play intervention.
Randomization
A total of 106 pairs of children and their parents who meet
with the eligible criteria during the data collection period
will be enrolled in this study. A list of 106 random numbers
will be generated by the Research Randomizer (2010) and
the Randomizer will randomly generate a set of 53 unique,
non-duplicating numbers from 1106. Each participant will
be randomly given a number from 1106. Participants
whose given number matches a number in the set list of 53
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Study protocol of therapeutic play for children

unique numbers will be allocated into the experimental

group; otherwise, into the control group.
Intervention
Control group. Children and their parents in the control
group will receive routine preparation (routine care,
including a video titled Preparing for your operation at the
participating hospital given to children and parents as a
pre-operative preparation for the child) before surgery.
Experimental group. In addition to the routine care, children and their parents in the experimental group will receive
the therapeutic play intervention at approximately 37 days
before their scheduled surgery (Brewer et al. 2006). The
therapeutic play intervention will be implemented to individual child and his/her parents. The childs parent (the
main caregiver) will also be invited to participate in the
intervention. The intervention will be conducted in a specially prepared room in the outpatient clinic of the participating hospital or at the patients preferred place (e.g. at his/
her home) based on his/her availability. The contents of the
therapeutic play intervention include watching a video entitled Preparing for your operation at the participating hospital, viewing photographs of operating theatre environment
and equipment, doll demonstration of pre-operation procedures as well as anaesthesia induction to the child and his/
her parent (e.g. obtaining vital signs, cardiac monitoring,
anaesthesia and intravenous therapy) and returned demonstration. The standardized therapeutic play intervention protocol is shown in Table 1. The whole therapeutic play
intervention will be standardized and last for approximately
1 hour. The researcher who will conduct the therapeutic
play will receive training from one of the collaborators, who
has received training by a research team on how to implement therapeutic play interventions for hospitalized children
in Hong Kong (Li et al. 2007a).
Outcome measures
The outcome measures include childrens and their parents
state anxiety, childrens emotional manifestation and postoperative pain. The state anxiety scale for children (SAS-C),
which is the short form of state-trait anxiety inventory for
children (Spielberger 1983), will be used to measure childrens anxiety level in this study. It is a frequently used
instrument with high validity and reliability (Spielberger
1983, Li & Lopez 2005a). The original version of SAS-C
was translated into Chinese by Li and Lopez (2004a).
Psychometric properties of the Chinese version have been
tested on children who have similar characteristics as the
children included in this study and showed high internal
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H.G. He et al.

Table 1 Standardized therapeutic play intervention protocol.

Time

Activity

Content

00:00

Virtual tour
(Video and photo file)

00:15

Doll Demonstration

00:30

Return Demonstration

00:45

Questions and Answers

Researcher dressed in operating theatre attire meets the children and their
parents at the childrens surgical clinic or at a childs home
(if the intervention is delivered at the childs home)
Watching of video clip entitled Preparing for your Operation at the Hospital
showing sequence of events the child
will go through on admission for elective surgery
Viewing of Photo File of operating theatre environment and equipment, including
operating table, anaesthetic and monitoring machines and operating lamp
Doll demonstration on obtaining vital signs for the child
Apply ECG electrodes on dolls upper chest and lower trunk
Place a pulse oximeter on the dolls finger
Attach a blood pressure cuff to the dolls arm
Apply a stethoscope to the dolls chest and explain how the doctors and
nurses will use it to listen to the childs heart and lungs
Doll demonstration on receiving oxygen and anaesthesia gas therapy
Explain the purpose of oxygen mask and anaesthesia gas
Apply the anaesthetic mask on the doll
Give the children the mask and ask them to try it on
Doll demonstration on Intravenous Therapy
Explain purpose of setting up an infusion line
Show them the soft catheter and demonstrate how this soft catheter
will be put into the dolls forearm
Encourage each child to return-demonstrate the procedure on the doll
with supervision and guidance
Clarify any misconceptions and queries
Reassure the children that they will be asleep during the whole surgical
procedure and will only wake up after the surgery

01:00

End of Therapeutic Play Intervention

consistency, concurrent validity and reliability (Li & Lopez

2004b). The content validity index (CVI) of the scale is 95%
(Li & Lopez 2004b). Testretest reliability coefficients of the
scale are 0.79 and the internal consistencies of the scale ranged from 0.730.92 (Li & Lopez 2004b). Chieng et al.
(2013a,b) had used SAS-C to measure 614-year-old childrens pre-operative anxiety in Singapore with Cronbachs
alpha of 0.88. Both the English and Chinese versions of SASC scale consist of 10 items (five items assessed for negative
feelings and five items assessed for positive feelings), each of
which is scored from 13. Thus, the lowest possible score is
10 and highest possible score is 30, with increasing scores
indicating increasing anxiety levels. In this study, participants can select either English or Chinese version of SAS-C
to measure their anxiety level at each time point.
Childrens Emotional Manifestation Scale (CEMS) will be
adopted in this study to measure childrens emotional
behaviour before the induction of anaesthesia. The CEMS
provides an objective method for nurses to assess childrens
emotional behaviour when they undergo stressful medical
procedures, such as surgery (Li & Lopez 2005a). As
436

reported, the internal consistency of the scale is high with

alpha coefficients of 0.92 and the CVI is 96% (Li & Lopez
2005a). There are five categories of emotional behaviours,
including facial expression, vocalization, activity, interaction and level of cooperation. Each category is scored from
15. Thus, the CEMS yields a minimum score of 5 and
maximum score of 25. The higher scores indicate more negative emotional manifestations displayed by the child,
which indicate higher levels of pre-operative anxiety.
Anxiety levels of parents will be measured using the State
Anxiety Scale for Adults (SAS-A). This scale contains 20
items (10 items assessed for negative feelings and 10 items
assessed for positive feelings), each of which is scored from
14. The lowest possible score is 20 and highest possible
score is 80, with higher scores indicating higher anxiety
levels. Psychometric properties were tested for both the
English and Chinese-translated versions (Spielberger 1983,
Shek 1988) with evidence showing high internal consistency, validity and reliability. In this study, participants can
select either English or Chinese version of SAS-C to measure their anxiety level at each time point.
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The Numeric Rating Scale (NRS) is a widely used instrument to assess the pain scores of children aged 6 and older
without difficulty in ranking (He et al. 2005). Children
were asked to rate their pain score from 0 (no pain at all)
10 (the worst ever pain). The psychometric properties tested
showed good reliability, validity and sensitivity (Farrar
et al. 2008, Hawker et al. 2011). The 2-week testretest
reliability analysis showed an interclass correlation coefficient of 0.83 (Farrar et al. 2008). The NRS demonstrated
high correlation with the visual analogue scale (VAS) (Hawker et al. 2011). In this study, NRS will be used to measure
childrens postoperative pain around 24 hours after surgery.
Demographic data, including age, gender, ethnicity and
nationality of children and their parents and marital status,
number of children, level of education, level of income and
occupation of parents, will be collected. Medical records of
all participants will be reviewed to obtain information on
the childs body weight, type of surgery, type of anaesthesia, anaesthetics used during the operation, duration of surgery, pain assessment conducted and pain medication used
within 24 hours after the operation, the length of hospital
stay and the history of previous hospitalization.
Process evaluation
Process evaluation will be used to identify the feasibility and
acceptability, strengths and weaknesses of the therapeutic
play intervention and the recommendation for the improvement of the intervention from the children and their parents perspectives according to an interview guide through
semi-structured interviews. It consists of a visual analogue
scale on satisfaction with the intervention in the postassessment and individual face-to-face interview with children
and their parents before discharge. Each interview will last
2030 minutes. All interviews will be audio-recorded.
Study procedure
Once Research Ethics Committee approval is granted by
the study hospital, the principal investigator and team will
liaise with the Nurse Managers of the participating hospital to ask for permission to gain access to the medical
records of children who are scheduled for surgery. An
invitation letter will be sent to all possible eligible parents
of children according to the medical records around
1 month before the operation, followed by phone call to
invite them to participate in this study. At the same time,
a researcher will stay at the clinic to recruit all possible
eligible children and their parents according to the selection criteria. All children and their parents who meet the
selection criteria will be invited to participate in the study.
The details of the study and the risks and benefits of par 2013 John Wiley & Sons Ltd

Study protocol of therapeutic play for children

ticipating in the study will be explained to all parents and

their children by using a participant information sheet.
Any questions from the parents and their children related
to the study will be adequately answered. Children and
their parents who agree to participate in this study will be
asked to sign the written assent and consent forms respectively. They will be randomly allocated to either the experimental or control group and will receive the interventions
accordingly.
Outcome will be measured at three time points: at baseline (37 days before the operation), on the day of surgery
and around 24 hours after the operation. When we first
contact the child and his/her parents, around 37 days
before the operation, their demographic data will be collected. Children and their parents will then be asked to
respond to the SAS-C or SAS-A respectively (baseline data).
Around 1 hour before the surgery, children and their parents will be asked to respond to the SAS-C and SAS-A,
respectively, again (postintervention 1 data, pre-operation).
In the holding area of the operating theatre, the research
assistant, who is unaware of the group assignment of the
children, will use CEMS to document emotional behaviours
of the children before anaesthesia induction. Around
24 hours after the operation or before discharge if the child
stays in the hospital less than 24 hours, childrens and their
parents state of anxiety and childrens postoperative pain
will be assessed using SAS-C, SAS-A and NRC respectively
(postintervention 2 data, postoperation). At the time when
pain is assessed, childrens blood pressures, pulse rates and
respiratory rates will also be recorded to ensure concurrent
validity. Process evaluation will be conducted immediately
after the postintervention 2 data collection is completed.
Medical records of all children participating in this study
will be reviewed at the end of the whole data collection
process to obtain their clinical data. Figure 2 presents the
CONSORT diagram of the study.
Data analysis
All quantitative data will be analysed using IBM SPSS
20.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics
will be used to summarize the demographic and clinical
data, the anxiety levels of children and their parents at
each time point, as well as childrens emotional manifestation and postoperative pain intensity. Both childrens
and their parents baseline anxiety scores in both groups
will be normalized using percentage change to ensure that
children and their parents in both the experimental and
control groups start at the same baseline zero. Percentage
change from baseline will be used for analysis by
repeated measures ANOVA adjusted for childrens demo437

H.G. He et al.

Screening and Recruiting

Randomisation (N = 106)
Baseline measurements (37 days before the operation):
Demographic data, SAS-C, SAS-A

Experimental group (n = 53)

Control group (n = 53)

Therapeutic play intervention +

Routine care (1 hour)

Routine care

Post-test 1data collection (Pre-operation):

Around one hour before the operation: SAS-C, SAS-A
Before the induction of anesthesia: CEMS

Post-test 2 data collection (Post-operation):

Around 24 hours after the operation: SAS-C, SAS-A, NRS, Process
Evaluation (selected participants) and Medical Record Review

Note:
SAS-C:
SAS-A:
CEMS:
NRS:

State anxiety scale for children

State-trait anxiety inventory for adults
Childrens emotional manifestation scale
Numeric rating scale

graphic and clinical data (e.g. gender, age and type of

surgery) or parents demographic data (e.g. gender, age
and ethnicity) to determine whether the intervention is
effective in reducing the anxiety levels of children or parents after the intervention respectively. Univariate analysis
of variance adjusted for childrens demographic and clinical data or parents demographic data will be used to
test the difference in percentage change in anxiety levels
of children or their parents, respectively, as well as mean
scores of childrens emotional behaviours before anaesthesia induction and mean scores of postoperative pain
between the experimental and control groups. The Pearson Product-moment Correlation Coefficient will be used
to determine the correlation among childrens perioperative anxiety levels, negative emotional behaviours and
postoperative pain and between childrens and their parents perioperative anxiety levels. The qualitative data
obtained from the interviews will be analysed by thematic
analysis (Morse & Field 1995, Lindseth & Norberg
2004).

Ethical considerations
Research Ethics Committee approval has been obtained
from the SingHealth Centralised Institutional Review Board
438

Figure 2 The CONSORT diagram of

this study.

(IRB Reference No: 2011/734/A) in October 2011. All children and their parents will be assured that all collected data
will be kept anonymous and confidential and that they can
withdraw from the study at any time without any negative
consequence. Parents written consent for their children and
their own participation in the study as well as childrens
assent will be obtained.

Validity and reliability

All data will be carefully checked immediately after the collection and problems (if any) will be corrected by the
researcher. Cross-check will be used for data verification
after the entry in SPSS. Descriptive analyses will be adopted
to identify any obvious data errors and outliers. All suspicious data will be checked with reference to the original
data sources. Related statistical assumptions will be tested
before conducting data analyses. This study is a randomized controlled trial with repeated measures study design.
All the variables including demographic and clinical data
and baseline outcome variables will be compared between
groups at the beginning to guarantee equivalence. If there
are any differences between the two groups at baseline for
outcome variables, they will be controlled statistically in
the analyses.
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JAN: RESEARCH PROTOCOL

Discussion
Interventions for reducing childrens perioperative anxiety
and postoperative pain are needed as they affect children
from different cultures undergoing surgery (e.g. He et al.
2006, Justus et al. 2006, Kain et al. 2006, Li et al. 2007b,
Vaughn et al. 2007, Kortesluoma et al. 2008, Chieng
et al. 2013a,b). Anxiety and pain can affect childrens
ability to cope with surgery and inhibit their postoperative
recovery (Lizasoain & Polaino 1995, Becher & Sing
1997). Although there are several studies exploring the
effect of feasible and effective therapeutic play on reduction in childrens perioperative anxiety and postoperative
pain around the world, similar studies are sparse in Asia.
While a study on therapeutic play intervention was conducted in Hong Kong (Li et al. 2007a, Li & Lopez 2008),
the participants were children undergoing minor day surgery. To the best of our knowledge, this study is the first
study conducted in Asia to analyse the effects of the therapeutic play on school-age children undergoing inpatient
surgical procedures.
Although the provision of pre-operative education to children undergoing selective surgery is common in many countries, most pre-operative preparations focus on procedural
information, while childrens psychological needs have seldom been taken into consideration (OConner-Von 2000,
Setoodeh et al. 2010). Literature review found only six randomized controlled or quasi-experimental studies conducted
to examine the effects of psychosocial interventions on perioperative anxiety and postoperative pain in children undergoing surgical procedures (Schafer 2004, Li et al. 2007a,
Gorayeb et al. 2009, Setoodeh et al. 2010, Wennstr
om
et al. 2011, Fincher et al. 2012). The main component of
the psychosocial interventions in these studies is the therapeutic play and almost all these studies recruited children
undergoing 1-day minor elective surgery.
However, these studies showed inconsistent conclusions in
anxiety, negative behaviour and postoperative pain, which
might be due to the heterogeneity of participants with various ages (from 212 years) (Gorayeb et al. 2009, Fincher et al.
2012), anxiety at baseline (Schafer 2004) and various sample
sizes from 20 (Gorayeb et al. 2009) to 203 (Li et al. 2007a).
Moreover, these studies did not control the effects of type of surgery and pain medication used on outcomes. Different types of
surgery and amounts of pain medication used may have different
impacts on childrens anxiety, emotional responses and postoperative pain. The present study will use randomized controlled trial
design to recruit school-age children (614 years old) undergoing
inpatient elective surgery to examine the effectiveness of the therapeutic play intervention on outcomes after controlling the effects
2013 John Wiley & Sons Ltd

Study protocol of therapeutic play for children

of type of surgery and pain medication used within 24 hours after

the surgery.
In this study, the therapeutic play intervention includes
watching video regarding the sequence of events the child
will go through on admission for elective surgery, viewing
photo file of operating theatre environment and equipment,
doll demonstration of anaesthesia induction and return demonstration for children aged 614 years . Play is an integral
part of childrens lives and it has long been recognized as a
vital element of psychological intervention to help children
overcome the stress of hospitalization (Erickson 1958). Children of different ages and development levels may have different ways to play, depending on their cognitive
development (Li et al. 2007a). Some criticized that play
might not be suitable for older children. However, previous
studies have demonstrated that older children can also benefit from tours and doll demonstrations (Smallwood 1988,
Ziegler & Prior 1994, LeRoy et al. 2003, Li et al. 2007a).
In this study, the therapeutic play intervention will be
delivered to children by two researchers who have
received training from the research team member who
has extensive experience in therapeutic play interventions
for hospitalized children. The researchers who conduct
the intervention will follow a standardized therapeutic
play intervention protocol, which will help ensure consistency. There is ongoing monitoring of the intervention by
the research team, either by discussion in the regular
monthly meetings or on-site observation of the intervention by the principal investigators. Thus, the quality of
the intervention can be guaranteed.
Previous therapeutic play study in the USA suggested that
recruitment could be low (Schafer 2004). The following
strategies would be used to enhance recruitment: (i) use
multiple recruitment methods, such as sending invitation
letter, making phone calls and face-to-face on-site recruitment; (ii) provide token of appreciation, such as a token of
S$20 (US16) voucher for the completion of three questionnaire surveys and S$30 (US$24) voucher for the return
transportation to attend the play intervention.

Limitations
Blinding of participants to the intervention is not possible as
participants in the intervention will be aware that they are
receiving play intervention provided by the researchers of
this study. The outcome variables of this study are based on
self-reports. This may be affected by social desirability, especially with regard to the level of anxiety. The use of objective
measurements, such as stress marker salivary cortisol
(Wennstr
om et al. 2011), is recommended in future studies.
439

H.G. He et al.

Conclusion
This study will identify a clinically useful and potentially
effective approach, therapeutic play intervention, to prepare
children for surgery by reducing perioperative anxiety of
children and their parents as well as childrens postoperative pain. It is imperative to conduct a randomized controlled trial to determine the benefits of the therapeutic play
intervention before recommending it as a suitable approach
to be used in the paediatric health settings.

Acknowledgements
We would like to express our deep appreciation to Ms Tan
Sok Chin, Ms Joanne Liam Li Wee, and the Nurse Managers and Clinicians of the Surgery Centre, Pediatric Clinic,
ENT Centre, Pediatric Surgical wards, Operating Theatre in
the study venue for their support to the study.

Funding
This study is funded by a grant from the National Medical
Research Council New Investigator Grant in Singapore
(NMRC Grant No.: NMRC/NIG/1056/2011).

Conflict of interest
There is no potential conflict of interest.

Author contributions
All authors have agreed on the final version and meet at
least one of the following criteria [recommended by the
ICMJE (http://www.icmje.org/ethical_1author.html)]:

substantial contributions to conception and design,

acquisition of data, or analysis and interpretation of
data;
drafting the article or revising it critically for important
intellectual content.

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