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临床试验/NCT00409552
NCT00409552已完成1 期

Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment

National Institute on Drug Abuse (NIDA)0 个研究点目标入组 10 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
主要终点
Pain rating reduction

研究概览

简要总结

A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.

排除标准

  • We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.

结局指标

主要结局

Pain rating reduction

时间窗: Following each trial

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

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