NCT04287491撤回不适用
Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in average pain as assessed by the visual analog scale (VAS)
研究概览
简要总结
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 13 years and older.
- •Patient (or health care proxy when applicable) must sign an ICF.
- •Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application.
- •Patients willing to participate and parents able to consent.
排除标准
- •Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions.
- •Subjects requiring procedures on the head are also excluded to the interference of the VR headset.
研究组 & 干预措施
Virtual Reality Group
Experimental
This group will receive the virtual reality intervention during out-patient bedside procedures.
干预措施: Oculus Go Virtual Reality System (Other)
结局指标
主要结局
Change in average pain as assessed by the visual analog scale (VAS)
时间窗: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Change in maximum pain level as assessed by VAS
时间窗: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
次要结局
- Change in oxygen saturation(Baseline, up to 2 hours)
- Incidence of intervention related adverse events(Baseline, up to 2 hours)
- Change in heart rate(Baseline, up to 2 hours)
研究者
Hadar Lev-Tov
Professor
University of Miami
研究点 (1)
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