The Effect of therapeutıc Game on Preschool chıldren

September 13, 2023 updated by: Filiz KARACA DEVELİ, Aydin Adnan Menderes University

The Effect of therapeutıc Game on nursıng ınıtıatıves and Fears of medıcal materıals ın Preschool chıldren

In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.

Study Overview

Status

Completed

Conditions

Detailed Description

Entrance: In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.

Aim: This study was planned to determine the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.

Method/ Data Collection Techniques:This research was planned as a quasi-experimental study with pretest-posttest and control group. The universe of the research will consist of 170 children studying in pre-school classes at the Chamber of Commerce Primary School located in the city center of Aydın. The sample size of the study was calculated using G*power analysis and it was found that a total of 70 children (study: 35 children, control: 35 children). However, considering the losses from the research and the possibility of children filling in the questionnaires incomplete or incorrectly, the number of children was increased by 10% and it was planned to complete the study with 80 (study: 40 children, control: 40 children) children. It is planned to collect the data between March 1 and June 1, 2023. The child to be included in the study and their parents will be informed about the study, verbal consent will be obtained from the children and written consent will be obtained from the parents. After obtaining parental consent about the study, the parents of the children in both the study and control groups will have to fill in the "Introductory Information Form" and the children will fill in the "Scale of Fear of Nursing Interventions and Used Materials in Children" before the therapeutic play. The therapeutic game content to be applied to the study group consists of four sessions organized by considering nursing interventions and materials used in the hospital. In each session, various game activities will be held with different materials. Therapeutic play activity will not be planned for the children in the control group. One week after the therapeutic play activities are completed, the children will have to fill out the "Scale of Fear Against Nursing Interventions and Used Materials in Children".

The data obtained in the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. In the analysis of study data, descriptive statistics, if the data show normal distribution, independent group-t-test and changes within the group repeated measurements Anova test; If it does not have a normal distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.

Expected Results: Thanks to the results obtained from this study, it is expected that the familiarity of children with nursing interventions and materials with the therapeutic play method in their own environment such as school will help them experience less fear and adapt easily during a possible hospital experience in the future.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aydın
      • Efeler, Aydın, Turkey, 09100
        • Filiz KARACA DEVELİ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Child's:

  • Between 60 months and 71 months (children over 71 months are educated in the first grade of primary education).
  • Having pre-school education
  • Absence of any mental and/or physical health problems that would prevent communication belonging to the parent. Belonging to the parent;
  • Literacy of the parents

Exclusion Criteria:

The child has any phobia or is receiving treatment for this issue.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic game to reduce fear of hospital and ambulance
therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.

  • Therapeutic play activities will not be performed with the children in the control group.
  • One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.
Experimental: Therapeutic game to reduce fear of injectors and eye drops
therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.

  • Therapeutic play activities will not be performed with the children in the control group.
  • One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.
Experimental: Therapeutic play to reduce fear of intrauterine and serum
therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.

  • Therapeutic play activities will not be performed with the children in the control group.
  • One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.
Experimental: Therapeutic play to reduce fear of EKG and EMG
therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.

  • Therapeutic play activities will not be performed with the children in the control group.
  • One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nursing interventions and fear of materials used in children scale
Time Frame: baseline and week 4
I am not afraid (1) I am extremely afraid (5). As the score increases, fear increases.
baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Filiz KARACA DEVELİ, Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AdnanMU-ÇSHH-FKD-01

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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