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

Hydrotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808738
• Other study ID #: DOKTORA TEZ
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Eskisehir Osmangazi University
• Contact: Elif nilay Ak
• Phone: 05536079124
• Email: kzlynilay[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrotherapy

Intervention

Behavioral:
• therapeutic play
therapeutic game will be played to prepare children for hydrotherapy treatment

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.