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临床试验/NCT07824427
NCT07824427已完成不适用

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

Yuzuncu Yil University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Pain Scores at the Post-Test Assessment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • - Children who did not meet the study inclusion criteria.

研究组 & 干预措施

AI-Generated Video Distraction via Virtual Reality

Experimental

干预措施: AI-Generated Video Distraction via Virtual Reality (Behavioral)

Control Group

No Intervention

结局指标

主要结局

Pain Scores at the Post-Test Assessment

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

mehmet bulduk

Principal Investigator

Yuzuncu Yil University

研究点 (1)

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