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Completed

NCT Number: NCT07824427

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

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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Key information

Age range

4 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl University Dursun Odabaş Medical Center

Van, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children who did not meet the study inclusion criteria.

Treatment and study plan

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.

Primary outcomes

  1. Pain Scores at the Post-Test Assessment

    Time frame: Immediately after the circumcision procedure

    Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Pain will be rated independently by the child, parent, and nurse.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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