Virtual Reality Before Pediatric Endoscopy

Not Applicable

Completed

• Conditions: Pediatric Anxiety Disorders

• Registration Number: NCT06771141
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

Brief Summary: Clinical Study

The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. This study aims to answer the following key questions:

Does the VR application reduce pre-endoscopy anxiety in children? Does the VR application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children?

Researchers will compare the effects of the VR application with standard care to assess its effectiveness.

Participants:

The experimental group will undergo a 15-minute VR session before the endoscopy.

The control group will receive standard care without VR. Anxiety levels and vital signs will be measured throughout the study.

This study aims to explore whether VR technology can serve as an effective stress management tool during pediatric medical procedure

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-29
• Primary Completion: 2024-11-26
• Study Completion: 2024-12-15
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children aged 8 to 17 years.
• Scheduled to undergo an endoscopy procedure.
• Able to provide assent, and their parents or legal guardians provide written informed consent.
• No prior exposure to virtual reality applications.
• Willing to participate in the study.

Exclusion Criteria

• Presence of a chronic medical condition affecting cardiovascular or respiratory systems.
• Diagnosed with a severe psychiatric disorder.
• Known visual or auditory impairments that could prevent participation in a virtual reality session.
• History of seizures or epilepsy.
• Unwillingness to participate or inability to comply with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Anxiety Levels in Pediatric Patients	Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.	The primary outcome measure is the change in anxiety levels among pediatric patients undergoing endoscopy. Anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children (STAIC), a validated tool for measuring anxiety in children. Scores will be measured before and after the intervention to determine the effectiveness of the virtual reality (VR) application compared to the control group receiving standard care.

Trial Locations

Locations (1)

Van Yüzüncü Yıl Üniversity; 🇹🇷 Van, Turkey