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AI-Generated Video Distraction Via Virtual Reality for Fear and Pain During Pediatric Circumcision

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Start date: Oct 17, 2025 to Jun 1, 2026
    • Primary completion date: May 5, 2026 to Sep 23, 2026
    • Study completion date: Aug 11, 2026 to Sep 23, 2026
    • Eligibility criteria expanded, about 19 words
  2. Secondary endpoints expanded, about 16 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Children in the intervention group received AI-generated video distraction via virtual reality, whereas children in the control group received routine care. Pain and emotional responses were assessed from the perspectives of the child, parent, and nurse. Physiological parameters were also measured before and after the procedure. The study aimed to determine whether AI-generated video distraction delivered via virtual reality reduces procedural fear and pain during pediatric circumcision.
Trial Details
NCT Number NCT07824427
Lead Sponsor Yuzuncu Yil University
Conditions
(from sponsor)		 Procedural Pain Relief, Virtual Reality, Fear, Child, Digital Health, Generative Artificial Intelligence, Artificial Intelligence (AI), Circumcision, Male
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov