An interventional study of Virtual Reality Video Session in Pediatric Anxiety Disorders, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Supportive care
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
4,874 studies on the registry are indexed under Anxiety Disorders; 1,394 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 4,180 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
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.
Time frame: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yıl University