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

The Effect of Therapeutic Gaming Used in Preparation for Hydrothera-py Treatment on Children's Pain, Fear and Emotional Indicators: A Ran-domized, Controlled, Treatment Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hydrotherapy
• Intervention / Treatment: Behavioral: therapeutic play

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elif Nilay ak; Phone Number: 05536079124; Email: kzlynilay@hotmail.com

Study Locations

• Turkey
  • Odunpazarı
    • Eskisehir, Odunpazarı, Turkey, 26000
      • Recruiting
      • Eskisehir Osmangazi University
      • Contact: Elif Nilay ak; Phone Number: 05536079124; Email: kzlynilay@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: therapeutic game group; therapeutic play will be played 10 minutes before the hydrotherapy treatment.	Behavioral: therapeutic play; therapeutic game will be played to prepare children for hydrotherapy treatment
No Intervention: control group; No intervention was given to the children prior to hydrotherapy treatment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in children's emotional status will be evaluated by applying the Children's Emotional Indicators Scale to the children by the researcher.	therapeutic game was played for children 10 minutes before hydrotherapy treatment	Emotional indicators will be evaluated at the 10th minute of hydrotherapy treatment.

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: child; therapeutic game; hyrotherapy
• Other Study ID Numbers: DOKTORA TEZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No