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NCT Number: NCT07335458

Reducing Fear and Anxiety in Children Through Free Play

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.

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Key information

Conditions

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osmaniye Korkut Ata University

Osmaniye, 80010, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entering the free play area

Other

playing in the free play area before surgery

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa KARA, Phd

CONTACT

[email protected]

+905059777429

Sponsors and collaborators

Lead sponsor

Osmaniye Korkut Ata University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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