Reducing Fear and Anxiety in Children Through Free Play

The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups. The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels. Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables. In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play. Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents. Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups. An a priori power analysis was performed using G\*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group. The hypotheses of the study were: H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores. H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group. H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores. H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group. H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores. H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group. H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.

NCT Number	NCT07335458
Lead Sponsor	Osmaniye Korkut Ata University
Conditions	Pediatric Nursing, Preoperative Anxiety, Parental Anxiety, Preoperative Fear
Enrollment	80 participants
Start Date	2025-08-01
Primary Completion	2026-02-01 (estimated)
Study Completion	2026-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-10