Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
研究概览
简要总结
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.
详细描述
This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and females between the age of 18 and 60 years
- •Ability to communicate orally
- •Ability to read and understand English
- •Body Mass Index between 20-35
排除标准
- •Women who are pregnant, trying to become pregnant, or who are breastfeeding
- •History of alcohol or substance abuse
- •Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
- •Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
- •Predisposition to severe motion sickness
- •Unusual sensitivity or lack of sensitivity to pain
- •Urine toxicology positive for opioids or benzodiazepines
研究组 & 干预措施
Low-dose pain medication
80min IV infusion of a low-dose pain medication
干预措施: Low-dose pain medication (Ketalar) and saline placebo (Drug)
saline placebo
80min IV infusion of a saline placebo
干预措施: Low-dose pain medication (Ketalar) and saline placebo (Drug)
结局指标
主要结局
Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
时间窗: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.
次要结局
未报告次要终点
研究者
Sam Sharar
Study Principal Investigator
University of Washington