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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN11421435
• Date of registration: 23/10/2014
• Prospective Registration: No
• Primary sponsor: Ministry of Health (Singapore)
• Public title: The effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery
• Scientific title: The effectiveness of therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: a randomized control trial
• Date of first enrolment: 01/11/2011
• Target sample size: 106
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11421435
• Study type: Interventional
• Study design: Randomized controlled two-group pretest and repeated post-tests single-blind experimental design (Treatment)
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Hong-Gu He

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Perioperative care
Surgery

Intervention(s)

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 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.

Primary Outcome(s)

1. 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(s)

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

Secondary ID(s)

NMRC/NIG/1056/2011

Source(s) of Monetary Support

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