The Effect of Therapeutic Play on Pain, Fear and Emotional Indicator

Not Applicable

Recruiting

• Conditions: Hydrotherapy
• Interventions: Behavioral: therapeutic play

• Registration Number: NCT05808738
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

This study was planned to determine the effect of therapeutic play and preparation for hydrotherapy treatment on pain, fear and emotional indicator levels in children with burn injuries.

It is an experimental randomized controlled study. The population of the research will be children between the ages of 3-6 who are hospitalized in the Pediatric Burn Intensive Care Unit. As a result of the power analysis using the G\*Power 3.0.10 program, at least 52 children in total (control group 26, therapeutic play group 26) with 50% power, 0.05 alpha margin of error, 0.80 beta margin of error and 20% effect size. was determined to be included in the study. However, considering the case losses, the number of children to be included in the study was determined as 64 by increasing the sample size by 20%. The data will be collected between the dates to be determined by the researcher after obtaining the ethics committee approval and written permission from the institution where the research will be conducted. Introductory information form, FLACC Pain Scale, Child Fear Scale and Child Emotional Indicators Scale will be used to collect research data.

The research will be conducted with the children of parents who agreed to participate in the study. There are two groups, the control group and the experimental group. While the routine practice of the clinic will be applied to the control group, creative therapeutic games will be played to the experimental group together with the routine practice. Children will be stratified according to their pain scores, fear scores and burn depth (degree) and will be assigned to an equal number of children in each group using the blocking method. Before the procedure, the introductory information form will be filled in by the researcher in line with the patient file and parent information. After parents are informed about which group the child is in, their written consent will be obtained.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Study Start: 2024-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• The child is between 3-6 years old
• The child is receiving the first hydrotherapy treatment in the clinic.
• Presence of second and/or third degree superficial and/or deep burns
• Volunteering of the child and family to participate in the research
• The child was given analgesics half an hour before the procedure.
• No simultaneous debridement during hydrotherapy
• Burn width between 20%-70%

Exclusion Criteria

• The child is younger than 3 years old, over 6 years old
• Presence of any other chronic disease other than burns
• The child is receiving mechanical ventilator support.
• Having a trecheostomy done to the child
• The child has been given sedative medication in the last 8 hours.
• Having a companion other than mother or father
• Hydrotherapy treatment takes less than 30 minutes, more than 45 minutes
• The child does not want to play

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
therapeutic game group	therapeutic play	therapeutic play will be played 10 minutes before the hydrotherapy treatment.

Primary Outcome Measures

Name	Time	Method
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.	Pain assessment will be done 30 minutes after hydrotherapy treatment.	therapeutic game was played for children 10 minutes before hydrotherapy treatment

Secondary Outcome Measures

Name	Time	Method
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.	Fear assessment will be done 30 minutes after hydrotherapy treatment.	therapeutic game was played for children 10 minutes before hydrotherapy treatment

Trial Locations

Locations (1)

Eskisehir Osmangazi University; 🇹🇷 Eskisehir, Odunpazarı, Turkey