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临床试验/NCT06245395
NCT06245395招募中不适用

Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Walter Reed National Military Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Wong-Baker FACES Pain Scale

研究概览

简要总结

The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.

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
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .

排除标准

  • patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia

研究组 & 干预措施

Virtual Reality Arm

Active Comparator

Pediatric patient receiving Virtual Reality during the otologic procedure.

干预措施: Virtual Reality (Device)

Standard of Care Arm

No Intervention

结局指标

主要结局

Wong-Baker FACES Pain Scale

时间窗: during the in clinic procedure

Subjective Units of Distress Scale

时间窗: during the in clinic procedure

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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