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Clinical Trials/NCT05790005
NCT05790005
Completed
N/A

The Effect of the Therapeutic Play Applied Before Surgical Dressing on Anxiety and Fear in Children

Aydin Adnan Menderes University1 site in 1 country92 target enrollmentApril 7, 2023
ConditionsAnxietyFear

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Aydin Adnan Menderes University
Enrollment
92
Locations
1
Primary Endpoint
Child fear scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this experimental study is to determine the effect of therapeutic play method applied to hospitalized children aged 7-12 before the first surgical dressing attempt, on anxiety and fear. Researcher will compare the study and control groups to see if therapeutic play has an effect on anxiety and fear.

Detailed Description

G-Power 3.1.9.4 package program was used for sample size calculation in the study. Children will be assigned to the study and control groups using the www.randomizer.org program with a simple randomization method to ensure homogeneity between the study and control groups. Before dressing, a warm-up play will be played for 10 minutes with the study group, followed by a 20-minute therapeutic game in which the dramatization method will be used. The children in the control group will be subjected to the routine dressing procedure. The data of the research will be collected using the Child and Parent Information Form, Child Anxiety Scale-State Scale and Child Fear Scale. During the evaluation of the data, the sociodemographic characteristics of the groups participating in the study will be stated as numbers and percentages, and the normal distribution of the anxiety scale and fear scale scores before the play, after the play and after the dressing process in the Intervention and control groups will be determined by looking at the skewness coefficients. The Factorial Anova Test will be used for mixed measurements in order to examine the anxiety and fear changes of the children in the Intervention and control groups before the play, after the play and after the dressing process. In addition, since this test does not measure the different changes between the groups, the Anova Test in Repeated Measurements will be used to compare the anxiety and fear scores of only the Intervention group and only the control group before the play, after the play and after the dressing process. If the data do not have a normal distribution, the Friedman Test, which is a nonparametric test, will be used.

Registry
clinicaltrials.gov
Start Date
April 7, 2023
End Date
December 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

Yeliz Ozer

Principal Investigator

Aydin Adnan Menderes University

Eligibility Criteria

Inclusion Criteria

  • Children in the 7-12 age group
  • Children who speak and understand Turkish
  • Children whose first dressing will be done in the service on the second day after the operation

Exclusion Criteria

  • Children with hearing, vision and speech problems in themselves or their parents
  • Children with a mental disorder in themselves or in their parents
  • Children who had circumcision surgery (because the primary dressing was removed and crystallin spray was sprayed on the surgical area and the area was left open)
  • Children who should not move before dressing (having hypospadias surgery)
  • Children still in the intensive care unit at the time of the first surgical dressing
  • Children whose dressing had to be changed before the second postoperative day (wetting, bleeding, opening, etc.)
  • Children with previous play therapy experience

Outcomes

Primary Outcomes

Child fear scale

Time Frame: immediately after the surgical dressing

The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

Child Anxiety Scale-State Scale

Time Frame: immediately after the surgical dressing

The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

Study Sites (1)

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