跳至主要内容
临床试验/NCT04545229
NCT04545229已完成不适用

Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Patient self-reported pain

研究概览

简要总结

A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.

详细描述

A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group will receive VR-PAT as a distraction tool during the dressing change procedure (active VR group) while the comparison groups will receive either a comparable passive VR distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (Control Group 1), or no distraction at all (Control Group 2).

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

盲法说明

In this pilot study, no masking was implemented.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult burn patient age 18-70
  • First admission for acute burn requiring dressing change
  • First admission for burn injury
  • Using Opioids for dressing changes
  • Burn is ≤ 4 days post burn

排除标准

  • Severe burn(s) on the face/head preventing utilization of VR
  • Cognitive/motor impairment preventing valid administration of study measures
  • Unable to communicate in English
  • Prisoners and patients who were pregnant
  • Patients admitted to the ICU

结局指标

主要结局

Patient self-reported pain

时间窗: During burn dressing changes

Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.

次要结局

  • Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.(Each day during inpatient hospital stays up to 7 days.)

研究者

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

Henry Xiang

Professor and Center Director

Nationwide Children's Hospital

研究点 (2)

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