跳至主要内容
临床试验/NCT04287491
NCT04287491撤回不适用

Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

University of Miami2 个研究点 分布在 1 个国家开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in maximum pain level as assessed by 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

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.

结局指标

主要结局

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.

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadar Lev-Tov

Professor

University of Miami

研究点 (2)

Loading locations...

相似试验

Use Of Virtual Reality For Pain Control in... | 临床试验