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

NCT07824427 — Not applicable, Completed, 80 participants, Yuzuncu Yil University

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AI-Generated Video Distraction Via Virtual Reality for Procedural Fear and Pain in Pediatric Circumcision: A Randomized Controlled Trial

Registry	NCT07824427
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	80 (Actual)
Sponsor	Yuzuncu Yil University (Other)
Conditions	Procedural Pain Relief, Virtual Reality, Fear, Child, Digital Health, Generative Artificial Intelligence, Artificial Intelligence (AI), Circumcision, Male
Interventions	AI-Generated Video Distraction via Virtual Reality (Behavioral)
Dates	start 2026-06-01, primary completion 2026-09-23, completion 2026-09-23, first posted 2026-09-17, last updated 2026-10-09
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
AI-Generated Video Distraction via Virtual Reality	Experimental	Behavioral: AI-Generated Video Distraction via Virtual Reality	Children in the intervention group watched a 3-minute artificial intelligence-generated video through a virtual reality headset before circumcision, in addition to routine care.
Control Group	No intervention		Children in the control group received routine care without the virtual reality video intervention.

AI-Generated Video Distraction via Virtual Reality (Behavioral): Artificial intelligence-generated video content is presented through a virtual reality headset as a distraction intervention for children undergoing circumcision. The intervention is intended to reduce procedural fear and pain.

+Outcome measures

Primary outcomes

Pain Scores at the Post-Test Assessment [1 hour after circumcision.]: Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity. The child, parent, and nurse independently rated the child's pain. Baseline pain was also assessed 30 minutes before circumcision in both groups.

Secondary outcomes

Preoperative Fear Scores [Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.]: Child-reported fear was assessed using the six-face Scary Scale, with scores ranging from 0 to 10. Higher scores indicate greater fear. Separate parent and nurse ratings of the child's fear were also recorded.
Preoperative State Anxiety Scores [Immediately before and immediately after the 3-minute preoperative video in the intervention group. Once at the corresponding baseline time point in the control group.]: Child-reported state anxiety was assessed using the Children's Anxiety Meter-State, a thermometer-like scale ranging from 0 to 10. Higher scores indicate greater anxiety. Separate parent and nurse ratings of the child's anxiety were also recorded.
Heart Rate [30 minutes before circumcision and 1 hour after circumcision in both groups.]: Heart rate was measured in beats per minute in both groups.
Body Temperature [30 minutes before circumcision and 1 hour after circumcision in both groups.]: Body temperature was measured in degrees Celsius in both groups.
Peripheral Oxygen Saturation [30 minutes before circumcision and 1 hour after circumcision in both groups.]: Peripheral oxygen saturation (SpO2) was measured as a percentage in both groups.
Respiratory Rate [30 minutes before circumcision and 1 hour after circumcision in both groups.]: Respiratory rate was measured in breaths per minute in both groups.

+Eligibility

Sex: Male, ages: 4 Years to 12 Years, accepts healthy volunteers

Inclusion Criteria:

* Male children aged 4 to 12 years.
* Children scheduled to undergo circumcision.
* Participation in the study with parental consent.

Exclusion Criteria:

* Presence of a neurodevelopmental disorder.
* Visual or hearing impairment that prevents viewing the video or completing the scales.
* History of epilepsy.
* History of motion sickness.

+Locations (1)

Facility	City	Country	Status
Van Yüzüncü Yıl University Dursun Odabaş Medical Center	Van, Van	Turkey (Türkiye)