Virtual Reality Before Pediatric Endoscopy

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

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

Study Overview

• Status: Completed
• Conditions: Pediatric Anxiety Disorders
• Intervention / Treatment: Behavioral: Virtual Reality Video Session

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65000
    • Van Yuzuncu Yıl University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Intervention Group; 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; 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.
No Intervention: Standard Care Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Actual): November 26, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2024/07-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared to prioritize the privacy and confidentiality of participants. Additionally, it has been specified in the ethical approval that the data will only be used for the purposes of this study and will not be shared with third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No