Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808738
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-01-08
Brief Title:
The Effect of Therapeutic Play on Pain Fear and Emotional Indicator
Sponsor:
Eskisehir Osmangazi University
Organization:
Eskisehir Osmangazi University
Study Overview
Official Title:
The Effect of Therapeutic Gaming Used in Preparation for Hydrothera-py Treatment on Childrens Pain Fear and Emotional Indicators A Ran-domized Controlled Treatment Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GPower 3010 program at least 52 children in total control group 26 therapeutic play group 26 with 50 power 005 alpha margin of error 080 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
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 GPower 3010 program at least 52 children in total control group 26 therapeutic play group 26 with 50 power 005 alpha margin of error 080 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None