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临床试验/NCT05297838
NCT05297838已完成不适用

The Utilization of a Stationary Bike During Ice Bath While Using Virtual Reality (VR) to Determine Overall Pain Reduction

Stanford University2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2022年7月25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
151
试验地点
2
主要终点
Sympathetic Activation (VR vs VR Bike)

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of different technologies, in particular Virtual Reality, inclusive of passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water while utilizing a stationary bike.

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
None

入排标准

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

入选标准

  • Greater than 18 years of age
  • English speaking
  • Hearing intact

排除标准

  • Patients who do not consent
  • Are currently taking beta blockers or other chronotropic heart medication(s)
  • Have a history of severe motion sickness
  • Currently have nausea
  • Currently experiencing seizures
  • Are clinically unstable

结局指标

主要结局

Sympathetic Activation (VR vs VR Bike)

时间窗: Duration of ice bath (approximately 0 - 4 minutes)

Assessed via the electrodermal activity (EDA biosensor), which recorded skin conductance response density (SCRD) data in 30 second epochs. SCRD was recorded for the duration of the cold pressor test and one minute before and after submersion. The same primary and secondary outcome measures were collected at identical time points during the different cold pressor challenges on each hand

Self-Reported Pain Scores (Ice Bath vs VR Bike)

时间窗: Duration of ice bath (approximately 0 - 4 minutes)

Pain Scores will be collected during ice bath (maximum of 4 minutes) every 30 seconds via numeric rating scale (NRS), 0 being no pain, 10 being worst pain imaginable

次要结局

  • Pain Tolerance (VR vs VR Bike)(Duration of ice bath (approximately 0 - 4 minutes))
  • Sympathetic Activation (Ice Bath vs VR Bike)(Duration of ice bath (approximately 0 - 4 minutes))
  • Self-Reported Pain Scores (VR vs VR Bike)(Duration of ice bath (approximately 0 - 4 minutes))
  • Pain Tolerance (Ice Bath vs VR Bike)(Duration of ice bath (approximately 0 - 4 minutes))

研究者

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

Samuel Rodriguez

Clinical Associate Professor

Stanford University

研究点 (2)

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