Clinical trial NCT06771141: Virtual Reality Before Pediatric Endoscopy
Official title: The Impact of Virtual Reality Application Before Endoscopy on Anxiety and Vital Signs in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anxiety Disorders
Keywords: Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Anxiety Levels in Pediatric Patients
timeFrame: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl Üniversity
Study officials:
References: