Virtual Reality Before Pediatric Endoscopy

Yuzuncu Yıl University

Status: Completed

Conditions: Pediatric Anxiety Disorders

Treatments: Behavioral: Virtual Reality Video Session

Study type: Interventional

Funder types: Other

Identifiers

NCT06771141

2024/07-25

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Virtual Reality Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Reality Video Session

Standard Care Control Group

No Intervention group

Description:

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.