Virtual Reality Before Pediatric Endoscopy

NCT06771141 | Completed

• 1 other identifier: 2024/07-25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Anxiety Disorders

Keywords

Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs

Outcome Measures

Primary Outcomes (1)

• Reduction in Anxiety Levels in Pediatric Patients

  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.

  Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.

Study Arms (2)

Virtual Reality Intervention Group

EXPERIMENTAL

This arm includes participants who will receive a 10-minute virtual reality (VR) session before their endoscopy procedure. The VR intervention aims to reduce anxiety and stabilize vital signs (e.g., systolic/diastolic blood pressure, heart rate, oxygen saturation) by providing an immersive and interactive experience designed to distract and relax the participants. Anxiety levels and vital signs will be measured pre- and post-intervention to evaluate its effectiveness.

Behavioral: Virtual Reality Video Session

Standard Care Control Group

NO INTERVENTION

Participants in this group will receive standard care prior to the endoscopy procedure, without the VR intervention. Anxiety levels and vital signs will be measured at similar intervals to compare with the experimental group.

Interventions

Virtual Reality Video Session BEHAVIORAL

This intervention involves a 10-minute virtual reality (VR) video session designed to reduce pre-procedural anxiety and promote relaxation in pediatric patients. The video immerses participants in a calming virtual environment with interactive and visually engaging content tailored for children. It is administered prior to the endoscopy procedure to help manage anxiety and stabilize vital signs, such as blood pressure, heart rate, and oxygen saturation. The VR session serves as a non-pharmacological approach to anxiety management during medical procedures.

Virtual Reality Intervention Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl Üniversity

Van, Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: his study uses a randomized controlled trial (RCT) design with a parallel assignment model. Participants are divided into two groups: the intervention group, which receives a virtual reality (VR) application before undergoing endoscopy, and the control group, which receives standard care. The study is open-label, meaning both participants and researchers are aware of the group assignments. This design allows for a direct comparison of the effects of the VR application on anxiety levels and vital signs in pediatric patients.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: July 29, 2024
• Primary Completion: November 26, 2024
• Study Completion: December 15, 2024
• Last Updated: January 14, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)