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

Evaluation of the Effects of Different Therapeutic Play Methods on Pre- and Post-operative Anxiety and Acute Symptoms in School-aged Children Aged 6-12

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?"

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Preoperative Anxiety
• Intervention / Treatment: Other: Finger Puppet Play; Other: Virtual Reality Play; Other: Smartphone Game Play

Detailed Description

Psychological stress experienced by children prior to surgical intervention can increase autonomic nervous system activation, thereby affecting pain perception, nausea development, hemodynamic variability, and the recovery process during the perioperative period. Therapeutic play interventions are non-invasive interventions that support children's coping skills with the surgical process through mechanisms such as distraction, cognitive restructuring, and emotional regulation. In recent years, technology-based approaches such as virtual reality have begun to be used in pediatric surgery as an alternative or complementary component to traditional play methods. However, randomized controlled data comparing the effects of these methods on physiological and psychological responses are still limited.

This study employs an experimental design aimed at examining the capacity of different game-based interventions administered during the preoperative period to regulate children's stress response. The intervention protocols target different mechanisms, including visual-auditory stimulation, cognitive attention guidance, imaginative play, and the use of interactive digital stimuli. Physiological changes are monitored at standardized time points, and early responses of the autonomic response (heart rate, blood pressure, breathing pattern) to game-based distractions are recorded for evaluation. Psychological assessments are structured to measure the child's emotional regulation capacity, anxiety level, and behavioral responses during the surgical process in a multidimensional manner.

Additionally, the study includes an assessment of the perioperative care experience from the family perspective. This assessment aims to understand the potential indirect effects of play interventions on parent-child interaction, parental trust in healthcare, and parental involvement in the care process. The multi-arm design of the study allows for the comparison of different therapeutic play techniques and the determination of which intervention potentially has a stronger effect on specific clinical outcomes.

The data obtained in this context aims to reveal the applicability, clinical effect profiles, and potential areas of application of play-based interventions for non-pharmacological anxiety management in pediatric surgical practice.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bilecik
    • Bilecik, Bilecik, Turkey (Türkiye), 11000
      • Bilecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Maintenance; This arm includes children who did not receive any therapeutic play intervention during the preoperative period and only underwent the standard clinical preparation process.
Experimental: Finger Puppet Therapeutic Game; 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; 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.
Experimental: Virtual Reality (VR) Game; 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; 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.
Experimental: Smartphone-Based Game; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Bilecik Seyh Edebali Universitesi
• Investigators: Principal Investigator: Dilek AYGİN, PROF. DR, Sakarya University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): May 10, 2025
• Study Completion (Estimated): May 10, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; virtual reality; Pediatric surgery; play therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Postoperative Complications
• Other Study ID Numbers: E-10333602-050.04-253950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) collected as part of the study will not be shared due to the inclusion of sensitive personal health information of child participants and the risk of re-identification. Access to IPD is restricted in accordance with data confidentiality and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No