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

Primary Purpose

Anxiety, Fear

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapeutic play
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Fear, Hospitalized Child, Dressings, Play, Operation

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Celal Bayar University Hafsa Sultan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

A therapeutic play will be played for 20 minutes after the warm-up play for 10 minutes before the first surgical dressing to be applied after the surgery with children in the 7-12 age groups. There will be 46 children in the intervention group.

Therapeutic play will be not played for 20 minutes after the 10-minute warm-up game before the first surgical dressing to be applied after the surgery with children in the 7-12 age group. The routine procedure applied in the service before the dressing process will be applied. There will be 46 children in the control group.

Outcomes

Primary Outcome Measures

Child Anxiety Scale-State Scale
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.
Child Anxiety Scale-State Scale
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.
Child Anxiety Scale-State Scale
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.
Child fear scale
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 fear scale
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 fear scale
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.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
April 29, 2023
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05790005
Brief Title
The Effect of Therapeutic Play Before Dressing on Anxiety and Fear in Children
Official Title
The Effect of the Therapeutic Play Applied Before Surgical Dressing on Anxiety and Fear in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear
Keywords
Anxiety, Fear, Hospitalized Child, Dressings, Play, Operation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups, the Intervention group and the control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
A therapeutic play will be played for 20 minutes after the warm-up play for 10 minutes before the first surgical dressing to be applied after the surgery with children in the 7-12 age groups. There will be 46 children in the intervention group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Therapeutic play will be not played for 20 minutes after the 10-minute warm-up game before the first surgical dressing to be applied after the surgery with children in the 7-12 age group. The routine procedure applied in the service before the dressing process will be applied. There will be 46 children in the control group.
Intervention Type
Other
Intervention Name(s)
therapeutic play
Intervention Description
2 days after the operation, 1 hour before the dressing, a warm-up game will be played with the child in the playroom of the pediatric surgery service, aiming to put the organs prepared by the researcher in their correct places on the picture for the first 10 minutes. Then, the teddy bear, which is given the appearance of an operation area by sewing a zipper on his stomach, will be given to the child and he will be asked to make the first dressing of the teddy bear. therapeutic game, in which the dramatization method is used, will last 20 minutes. During the 30-minute play practice, the child's questions will be answered.
Primary Outcome Measure Information:
Title
Child Anxiety Scale-State Scale
Description
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.
Time Frame
two hours before the surgical dressing
Title
Child Anxiety Scale-State Scale
Description
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.
Time Frame
fifteen minutes before the surgical dressing
Title
Child Anxiety Scale-State Scale
Description
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.
Time Frame
immediately after the surgical dressing
Title
Child fear scale
Description
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.
Time Frame
two hours before the surgical dressing
Title
Child fear scale
Description
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.
Time Frame
fifteen minutes before the surgical dressing
Title
Child fear scale
Description
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.
Time Frame
immediately after the surgical dressing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeliz Özer, Student
Phone
05530927438
Email
2122100303@stu.adu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Hüsniye Çalışır, Prof. Dr.
Phone
05056807219
Email
hcalisir@adu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hüsniye Çalışır, Prof. Dr.
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Celal Bayar University Hafsa Sultan Hospital
City
Manisa
State/Province
Uncubozköy
ZIP/Postal Code
45010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeliz Özer, Student
Phone
05530927438
Email
2122100303@stu.adu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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