Evaluation of Therapeutic Play Methods on Preoperative Anxiety and Acute Postoperative Symptoms in School-Age Children

NCT07353697 | Active Not Recruiting

• 1 other identifier: E-10333602-050.04-253950
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of different therapeutic play methods (finger puppet play, virtual reality glasses, and smartphone games) applied to children aged 6-12 years during the preoperative period on their anxiety levels and postoperative acute symptoms. The study has a randomized controlled design conducted in a pediatric surgery clinic. The research seeks to answer the following question: "Are different therapeutic play methods effective in reducing anxiety, fear, pain, and other acute symptoms in children during the surgical process?"

Conditions

Postoperative Complications; Preoperative Anxiety

Keywords

Pediatric surgery; play therapy; virtual reality; anxiety

Outcome Measures

Primary Outcomes (1)

• Changes in State Anxiety Scores in Children During the Preoperative Period

  Anxiety level is assessed using the State Anxiety Inventory for Children, which consists of 20 items with total scores ranging from 20 to 60. Higher scores indicate higher levels of anxiety, whereas lower scores indicate lower levels of anxiety. Anxiety assessments are conducted at four time points: preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); and approximately 30 minutes before discharge (Day 1).

  Preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); approximately 30 minutes before discharge (Day 1)

Study Arms (4)

Standard Maintenance

NO INTERVENTION

This arm includes children who did not receive any therapeutic play intervention during the preoperative period and only underwent the standard clinical preparation process.

Finger Puppet Therapeutic Game

EXPERIMENTAL

This arm includes children who participated in the structured finger puppet therapeutic play activity administered by the researcher during the preoperative period. The intervention involves interaction with age-appropriate puppets and guided play-based distraction techniques.

Other: Finger Puppet Play

Virtual Reality (VR) Game

EXPERIMENTAL

This arm includes children who participated in an interactive VR game experience using virtual reality goggles during the preoperative period. The intervention is based on visual and auditory stimuli aimed at distracting the child's attention from the surgical process.

Other: Virtual Reality Play

Smartphone-Based Game

EXPERIMENTAL

This arm includes children who experience distraction and game-focused interaction guided by an age-appropriate smartphone game during the preoperative period.

Other: Smartphone Game Play

Interventions

Finger Puppet Play OTHER

Finger Puppet Play - Intervention Description This intervention is a guided therapeutic play activity that involves the child interacting with age-appropriate finger puppets during the preoperative period. The application is conducted by the researcher according to a standard protocol and combines imaginative play with attention-focused play techniques. The intervention aims to regulate the child's emotions, divert their attention away from the surgical process, and create a relaxing play environment through puppet characters.

Finger Puppet Therapeutic Game

Virtual Reality Play OTHER

Virtual Reality Play - Intervention Description This intervention involves directing the child to an age-appropriate visual-auditory gaming experience through virtual reality goggles. VR content provides interactive environments designed to distract the child's attention away from the surgical process. The application is carried out for a fixed period of time and according to a standardized protocol. The intervention is a technology-based distraction technique that aims to reduce anxiety and tension by providing multi-sensory stimulation.

Virtual Reality (VR) Game

Smartphone Game Play OTHER

Smartphone Game Play - Intervention Description This intervention is based on the child playing an age-appropriate smartphone game selected by the researcher during the preoperative period. The application uses one-way or interactive game content and is carried out for a standard period of time. The intervention is designed as an easily accessible digital distraction method and aims to divert the child's cognitive focus away from the surgical process.

Smartphone-Based Game

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 12 years
• Hospitalized at Bilecik Training and Research Hospital, Department of Pediatric Surgery, for an elective surgical procedure
• Able to read and write
• Able to communicate in Turkish
• No visual, hearing, or speech impairments
• No intellectual disability or physical or surgical condition that would interfere with participation
• Voluntary participation with written informed consent obtained from the child and the parent or legal guardian

You may not qualify if:

• Children referred to the intensive care unit
• Children requiring repeat surgical intervention
• Children with a hospital stay of two days or longer
• Children with severe psychiatric disorders

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Training and Research Hospital

Bilecik, Bilecik, 11000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Dilek AYGİN, PROF. DR

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: May 10, 2024
• Primary Completion: May 10, 2025
• Study Completion (Estimated): May 10, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)