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临床试验/NCT07249359
NCT07249359已完成不适用

Effect of Virtual Reality on Dental Anxiety in Children With Mild Intellectual Disability: A Randomized Controlled Trial

Oasi Research Institute-IRCCS2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Treatment success

研究概览

简要总结

Virtual reality (VR) is a promising non-pharmacological approach to reduce dental anxiety in children with neurodevelopmental disorders. This randomized controlled trial compared a VR-based distraction intervention with conventional monitor-based distraction in children aged 11-15 years with mild intellectual disability and moderate dental anxiety undergoing conservative dental treatment.

研究设计

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

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 11-15; diagnosis of mild intellectual disability (DSM-5)
  • Moderate anxiety (Corah DAS 9-12)
  • ≥1 decayed tooth requiring conservative treatment under local anesthesia
  • Informed consent from parents/legal guardians

排除标准

  • no or slight anxiety
  • high or severe anxiety
  • visual disorders
  • neuromuscular comorbidities interfering with cooperation

结局指标

主要结局

Treatment success

时间窗: Duration of procedure

Number of patients with completion of restorative dental procedure under local anesthesia within 50 minutes and positive overall treatment experience (dichotomous: success vs. failure)

Treatment success

时间窗: Duration of procedure

Number of patients with completion of restorative dental procedure under local anesthesia within 50 minutes and positive overall treatment experience (dichotomous: success vs. failure)

次要结局

未报告次要终点

研究者

发起方
Oasi Research Institute-IRCCS
申办方类型
Other
责任方
Sponsor

研究点 (2)

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