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临床试验/NCT00682682
NCT00682682已完成不适用

Reducing Brief Thermal and Electrical Pain (Four Study Days)

University of Washington2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Efficacy of VR distraction with and without opioid when pain stimulus is applied.

研究概览

简要总结

Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.

This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.

Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.

Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.

Subjects will participate in each of the four conditions in which the order is randomized.

  • No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction
  • No opioids + yes virtual reality Snow World distraction
  • Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality
  • Moderate dose of pain medicine + yes virtual reality Snow World distraction

It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).

详细描述

In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.

These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women 18-45 years old
  • Normal height and weight ratio

排除标准

  • women who are pregnant and nursing
  • history of substance abuse
  • access to opioids in the workplace
  • smokes cigarettes
  • history of medical problems with the following: heart, lungs, liver, kidneys, endocrine, neurologic, migraines, or psychiatric requiring medical intervention
  • chronic pain
  • allergy or hypersensitivity to opioids, velcro, or latex
  • severe motion sickness
  • unusual sensitivity or lack of sensitivity to pain
  • sensitive skin or feet

结局指标

主要结局

Efficacy of VR distraction with and without opioid when pain stimulus is applied.

时间窗: at completion of study

次要结局

未报告次要终点

研究者

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

Chris Hoffer

Research Coordinator

University of Washington

研究点 (2)

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