Reducing Fear and Anxiety in Children Through Free Play

January 1, 2026 updated by: Mustafa KARA, Osmaniye Korkut Ata University

Free Play Surgery The Effects of Children's Fear and Anxiety and Parental Anxiety During the Intervention Process

The aim of this study is to determine the effect of free play activities fear levels, and parental anxiety experienced before and after surgical intervention in children aged 4-10 years. The research is planned as a randomized controlled trial. The study population consists of children aged 4-10 years and their parents who will undergo planned surgical procedures in the pediatric surgery department of a university hospital. The sample will be selected using a convenience sampling method and will consist of individuals who volunteer to participate in the study. The data collection process in the study was planned in two stages, with experimental and control groups: pre-test and post-test. Tests for both groups will be administered prior to the planned surgical operation. A pre-test for the children and their parents in the experimental group will be administered approximately 2 hours before the surgical procedure, just before the start of the free play intervention. At this stage, baseline data will be obtained by measuring the children's fear and anxiety levels and the parents' anxiety levels. Following this, the children will be given approximately 30 minutes of free play. A post-test will be administered immediately after the play intervention, approximately 45 minutes before surgery. This measurement, along with the effect of free play on the dependent variables, will be used to evaluate the results. In the control group, no intervention will be applied, and routine procedures will continue. This group will also be assessed with a pre-test approximately 2 hours before surgery and a post-test approximately 30-60 minutes before surgery to evaluate their levels of fear and anxiety. This will allow for a comparison of any significant differences between the two groups. This timing aims to assess the children's anxiety and fear during the period when they experience the most intense anxiety and fear before surgery, and to validly measure the effectiveness of free play. Study Population: The study population consists of children aged 4-10 years who will undergo surgical intervention and their parents. Study Sample: The study will include children aged 4-10 years who require surgical intervention and their mothers and/or fathers. Participants will be randomly assigned to experimental and control groups. A review of similar studies in the literature shows that Sert (2023) worked with 70 people (35 experimental, 35 control group). Tuncay and Tüfekçi (2019) completed their research with 60 people, and Scarano et al. with 50 people. Similar to these studies, this study is planned to be completed with 70 people, 35 in the experimental group and 35 in the control group.

The hypotheses of the study are: H0.1: Free play has no significant effect on the fear and anxiety levels of children undergoing surgery. H1.1: The pre-operative fear and anxiety levels of children who underwent free play differ significantly from those in the control group. H0.2: Free play has no significant effect on the situational anxiety levels of parents whose children are undergoing surgery. H1.2: Free play has a significant effect on the situational anxiety levels of parents whose children are undergoing surgery. H0.3: There is no significant relationship between the mother's situational anxiety level and the child's fear and anxiety levels. H1.3: There is a significant relationship/difference between the mother's situational anxiety level and the child's fear and anxiety levels.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

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 Contact

Study Locations

  • Turkey (Türkiye)
      • Osmaniye, Turkey (Türkiye), 80010
        • Recruiting
        • Osmaniye Korkut Ata University

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:

  • The participant's age must be between 4-10 age range.
  • The child's parent must agree to participate in the study voluntarily.

Exclusion Criteria:

  • The participant's age must be outside the 4-10 age range.
  • Having a chronic disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental : Intervention group
Children taken to the playground
Other: Entering the free play area
playing in the free play area before surgery
No Intervention: Other: Game interference
Allowing patients in the intervention group to spend approximately 45 minutes in a free play area before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's State Anxiety Scale (CSA) score (0-10)
Time Frame: Baseline (preoperative, immediately before surgery)
Children's State Anxiety (CSA) is a visual, thermometer-like self-report scale for children aged 4-10 years. The child is asked to mark how anxious/nervous they feel 'right now'. Scores range from 0 to 10. The child's mark is read using 0.5-point increments and then rounded to the nearest whole number; higher scores indicate greater state anxiety
Baseline (preoperative, immediately before surgery)
Children's Fear Scale (CFS) score (0-4)
Time Frame: Baseline (preoperative, immediately before surgery)
Children's Fear Scale (CFS) is a single-item faces scale consisting of five drawn facial expressions ranging from 0 (no anxiety/fear; neutral face) to 4 (severe anxiety/fear; frightened face). The scale will be completed independently by the child, the parent/caregiver, and a trained researcher. Scores range from 0 to 4; higher scores indicate greater fear/anxiety
Baseline (preoperative, immediately before surgery)
Parental anxiety assessed by Visual Analog Scale (VAS, 0-100)
Time Frame: Baseline (preoperative, immediately before surgery)
Parental anxiety is rated using a 0-100 mm Visual Analog Scale (VAS), where 0 indicates no anxiety and 100 indicates the worst imaginable anxiety
Baseline (preoperative, immediately before surgery)

Collaborators and Investigators

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

Sponsor

Osmaniye Korkut Ata University

Investigators

  • Principal Investigator: Mustafa KARA, PhD, Osmaniye Korkut Ata 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)

June 1, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E.229701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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