Virtual Reality Before Pediatric Endoscopy

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

Completed

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Key information

Conditions

Pediatric Anxiety Disorders Anxiety Disorders Mental Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl Üniversity

Van, 65000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Reduction in Anxiety Levels in Pediatric Patients

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

The Impact of Virtual Reality Application Before Endoscopy on Anxiety and Vital Signs in Children

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 13, 2025
Registry last updated: Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed