NCT06245395招募中不适用
Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures
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
- 是
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
研究点 (2)
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