Free play to reduce pre-surgery fear and anxiety in children
Free Play Surgery The Effects of Children's Fear and Anxiety and Parental Anxiety During the Intervention Process
This trial will try free play activities to see if they lower fear in children aged 4–10 and reduce their parents' anxiety before planned surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Osmaniye Korkut Ata University Academic / other |
| Locations | 1 site (Osmaniye) |
| Trial ID | NCT07335458 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial conducted in the pediatric surgery department of a university hospital that compares a free play intervention to usual care in children scheduled for elective surgery. Children aged 4–10 and their parents will be recruited by convenience sampling and randomly assigned to experimental or control groups. Baseline measures will be taken before the operation, with the experimental group receiving a free play session about two hours before surgery and both groups assessed again after the intervention. The primary outcomes are child fear levels and parental anxiety measured pre- and post-intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 4–10 undergoing planned (elective) surgical procedures at the study hospital whose parent or guardian agrees to participate.
Not a fit: Children outside the 4–10 age range, those with chronic diseases, or those undergoing emergency procedures are not expected to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, the free play approach could reduce children's preoperative fear and lower parental anxiety, making the surgical experience less stressful and easier to manage.
How similar studies have performed: Previous research on play-based and distraction interventions has often shown reductions in preoperative anxiety in children, although methods and effect sizes have varied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Osmaniye
- Osmaniye Korkut Ata University — Osmaniye, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Mustafa KARA, PhD — Osmaniye Korkut Ata University
- Study coordinator: Mustafa KARA, Phd
- Email: mustafaakara@hotmail.com
- Phone: +905059777429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.