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临床试验/NCT03268863
NCT03268863已完成不适用

Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy

Janet Vittone2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Pain Tolerance

研究概览

简要总结

This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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
是

入选标准

  • •Healthy adult Mayo Clinic students and employees

排除标准

  • •Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness)
  • •Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic
  • •dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain
  • •Participants that have used drugs/alcohol the day prior to the study

研究组 & 干预措施

Virtual Reality

Experimental

Google Cardboard Virtual Reality headset running an interactive game

干预措施: Virtual Reality (Device)

Virtual Reality

Experimental

Google Cardboard Virtual Reality headset running an interactive game

干预措施: Cold Pressor (Other)

Control

Sham Comparator

Powered down Google Cardboard Virtual Reality headset

干预措施: Cold Pressor (Other)

结局指标

主要结局

Pain Tolerance

时间窗: 10 minutes

Likert Scale, 0-10

次要结局

  • Pain threshold(10 minutes)
  • maximal pain(10 minutes)
  • Nausea(10 minutes)

研究者

发起方
Janet Vittone
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Janet Vittone

Consultant, General Internal Medicine

Mayo Clinic

研究点 (2)

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