The effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery

ISRCTN ISRCTN11421435
DOI https://doi.org/10.1186/ISRCTN11421435
Secondary identifying numbers NMRC/NIG/1056/2011
Submission date
10/10/2014
Registration date
23/10/2014
Last edited
29/03/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 child’s 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 child’s 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

Contact information

Dr Hong-Gu He
Scientific

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

Phone +65 (0) 6516 7448
Email nurhhg@nus.edu.sg

Study information

Study designRandomized controlled two-group pretest and repeated post-tests single-blind experimental design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: a randomized control trial
Study objectives1. 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 child’s operation) than those in the control group
3. There will be significantly positive correlation among children’s anxiety level, emotional manifestation, and postoperative pain
4. There will be significantly positive correlation between children’s and their parents’ anxiety level
Ethics approval(s)SingHealth Centralized Institutional Review Board (CIRB), ref: 2011/734/A
Health condition(s) or problem(s) studiedPerioperative care
InterventionEligible 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 Children’s 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 typeProcedure/Surgery
Primary outcome measure1. Children’s 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 Children’s 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 measuresParents’ 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 study start date01/11/2011
Completion date30/10/2014

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants106 pairs of parents and their 6-14-year-old children who undergo inpatient elective surgery
Key inclusion criteriaChildren:
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
Key exclusion criteriaChildren:
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
Date of first enrolment01/11/2011
Date of final enrolment30/10/2014

Locations

Countries of recruitment

  • Singapore

Study participating centre

National University of Singapore
Singapore
117597
Singapore

Sponsor information

Ministry of Health (Singapore)
Government

11 Biopolis Way Helios
#09-10/11
Singapore
138667
Singapore

Phone +65 (0) 6325 8130
Email moh_nmrc@moh.gov.sg
Website http://www.nmrc.gov.sg/content/nmrc_internet/home.html
ROR logo "ROR" https://ror.org/00mrhvv69

Funders

Funder type

Government

Ministry of Health, National Medical Research Council New Investigator Grant 2011 (Singapore) (Award No.: NMRC/NIG/1056/2011)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/02/2014 Yes No
Results article results 01/05/2015 Yes No
Results article results 01/07/2015 Yes No

Editorial Notes

29/03/2016: Publication reference added.