NCT07353697

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Bilecik Seyh Edebali Universitesi · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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?"

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.

Conditions

• Preoperative Anxiety
• Postoperative Complications

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2024-05-10
• Primary completion: 2025-05-10
• Completion: 2026-05-10
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Turkey (Türkiye)