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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osmaniye Korkut Ata University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Pediatric Nursing

Clinical Trials on Entering the free play area

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings