Plain English Summary
Background and study aims
Children undergoing inpatient elective surgeries (surgery in hospital that has been arranged in advance rather than medical emergencies) often feel stressed and anxious. If the child feels very anxious, it can affect their ability to cope with surgery, make them behave uncooperatively towards healthcare providers and affect how well they recover afterwards. They can become emotional, crying and protesting loudly as they are being anaesthetised. The pain experienced after surgery can also feel worse if the child feels anxious about it. Parents can also experience a considerable amount of anxiety when their child has an operation and if a child senses a parents anxiety, it can make their own anxiety worse. It is therefore important to find a way (intervention) that will ease the anxiety felt by both the parents and the child in order to make the experience less stressful. Research has shown than therapeutic play can reduce the amount of anxiety felt by children in hospital, but there have not been many studies yet that have explored how therapeutic play might reduce anxiety in children about to have elective surgery. The results from the studies that have taken place have been inconsistent in terms of whether either the childs anxiety, behaviour and pain or their parents anxiety have been improved though therapeutic play. In addition to this, factors such as the types of surgery performed or pain medication given were not controlled in any of them. Here, we are going to perform a rigorous, experimental study to examine the effects of a therapeutic play intervention on children about to have inpatient elective surgery and their parents while controlling for possible confounding factors.
Who can participate?
Children aged between 6-14 years undergoing inpatient elective surgery in a public hospital and their parents.
What does the study involve?
Participants (child and parents) are randomly allocated into one of two groups. Those in group 1 are assigned to a control group and are given routine care. Those in group 2 are assigned to the experimental group and are given routine care and a 1 hour therapeutic play intervention. This includes watching a video, looking at photos of an operating theatre and a demonstration of what happens using a doll. For both groups, the childs feeling of anxiety, how they behave and the pain they experience after the operation is assessed 3-7 days before the operation, on the day of the surgery and around 24 hours after the operation. The parents feeling of anxiety is measured at the same time.
What are the possible benefits and risks of participating?
There is no risk to participating in this study. The only inconvenience will be the time spent filling in three questionnaire surveys and the one-hour therapeutic play intervention (experimental group only).
Where is the study run from?
KK Women and Children Hospital (Singapore)
When is the study starting and how long is it expected to run for?
November 2011 to October 2014
Who is funding the study?
Ministry of Health, National Medical Research Council New Investigator Grant 2011 (Singapore)
Who is the main contact?
Dr He Hong-Gu
nurhhg@nus.edu.sg
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hong-Gu He
ORCID ID
Contact details
Alice Lee Centre for Nursing Studies
Yong Loo Lin School of Medicine
National University of Singapore
Level 2
Clinical Research Centre
Block MD11
10 Medical Drive
Singapore
117597
Singapore
+65 (0) 6516 7448
nurhhg@nus.edu.sg
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NMRC/NIG/1056/2011
Study information
Scientific title
The effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: a randomized control trial
Acronym
Study hypothesis
1. Children in the experimental group will report significantly lower levels of pre- and post-operative anxiety, fewer negative emotion manifestations before the anesthesia induction and less postoperative pain than those in the control group
2. 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
3. There will be significantly positive correlation among childrens anxiety level, emotional manifestation, and postoperative pain
4. There will be significantly positive correlation between childrens and their parents anxiety level
Ethics approval
SingHealth Centralized Institutional Review Board (CIRB), ref: 2011/734/A
Study design
Randomized controlled two-group pretest and repeated post-tests single-blind experimental design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Perioperative care
Intervention
Eligible participants (child and his/her parent in dyad) 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. 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.
The intervention group will be provided a therapeutic play intervention which includes watching a video entitled 'Preparing for your operation' at the participating hospital, viewing photos 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.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. Childrens perioperative anxiety: measured by the State Anxiety Scale for Children (SAS-C) at baseline (3-7 days before operation), on the surgery day, and around 24 hours after the operation
2. Negative emotional manifestations: measured by the Childrens Emotional Manifestation Scale (CEMS) before the induction of anaesthesia
3. Postoperative pain: measured by the Numeric Rating Scale (NRS) around 24 hours after the operation
Secondary outcome measures
Parents perioperative anxiety: measured by the State Anxiety Scale for Adults (SAS-A) at baseline (3-7 days before operation), on the surgery day, and around 24 hours after the operation
Overall trial start date
01/11/2011
Overall trial end date
30/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children:
1. Age between 6 and 14 years old
2. Will undergo an inpatient elective surgery
3. Able to communicate verbally and be literate in either English or Chinese
4. Are accompanied by their parents (either mother or father or both) during the perioperative period
Parents:
1. Main caregiver of the child who meets the inclusion criteria
2. Able to communicate verbally and be literate in either English or Chinese
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
106 pairs of parents and their 6-14-year-old children who undergo inpatient elective surgery
Participant exclusion criteria
Children:
1. Having past experience of surgery
2. Having cognitive and learning disabilities identified from their medical records
3. Having a chronic illness and/or pain that requires special medical care
Parents:
1. Guardians of the child
2. Those who have past experiences of their child undergoing surgery
Recruitment start date
01/11/2011
Recruitment end date
30/10/2014
Locations
Countries of recruitment
Singapore
Trial participating centre
National University of Singapore
Singapore
117597
Singapore
Sponsor information
Organisation
Ministry of Health (Singapore)
Sponsor details
11 Biopolis Way Helios
#09-10/11
Singapore
138667
Singapore
+65 (0) 6325 8130
moh_nmrc@moh.gov.sg
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health, National Medical Research Council New Investigator Grant 2011 (Singapore) (Award No.: NMRC/NIG/1056/2011)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23991679
2. Wee CYH, Chan WCS, Li HCW, Liam LWJ, He HG (2014). Research in brief - A pilot study of the effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery. Singapore Nursing Journal, 41(2): 35.
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25561079
4. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25682703
Publication citations
-
Protocol
He HG, Zhu L, Li HC, Wang W, Vehviläinen-Julkunen K, Chan SW, A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol., J Adv Nurs, 2014, 70, 2, 431-442, doi: 10.1111/jan.12234.
-
Results
He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W, Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial., J Adv Nurs, 2015, 71, 5, 1032-1043 , doi: 10.1111/jan.12608.
-
Results
Wee CYH, Chan WCS, Li HCW, Liam LWJ, He HG, Research in brief - A pilot study of the effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery, Singapore Nursing Journal, 2014, 41, 2, 35.
-
Results
He HG, Zhu LX, Chan WC, Liam JL, Ko SS, Li HC, Wang W, Yobas P, A mixed-method study of effects of a therapeutic play intervention for children on parental anxiety and parents' perceptions of the intervention, J Adv Nurs, 2015 , 71, 7, 1539-1551, doi: 10.1111/jan.12623.