Pediatric Anxiety Disorders
Conditions
Keywords
Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs
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
Interventions
BEHAVIORALVirtual 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.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Anxiety Levels in Pediatric Patients | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed