NCT05130307已完成不适用
Virtual Reality Analgesia for Brief Thermal Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Worst pain, baseline, participant's rating of "worst pain" during baseline measure
研究概览
简要总结
Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.
详细描述
This study will use Quantitative Sensory Testing (computer-controlled brief 10 second thermal pain stimuli) in healthy college students.
The primary aim is to conduct a randomized, controlled study with healthy volunteers to explore whether interacting with virtual objects in VR via a highly immersive VR system makes VR significantly more effective/powerful compared to a less immersive VR system, vs. No VR, for reducing pain during quantitative sensory testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Although no deception is involved, participants who receive VR will remain unaware of the immersiveness of the VR systems they are receiving.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- •Able to read, write and comprehend English
- •Able to complete study measures
- •Willing to follow our UW approved instructions
- •18 years of age or older
- •Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- •Able to read, write and comprehend English
- •Able to complete study measures
- •Willing to follow our UW approved instructions
- •18 years of age or older The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.
- •COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).
- •All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.
- •If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study (non-vaccinated students need a recent negative COVID-19 test from the UW before participating in the non-VR educational materials option.
排除标准
- •People how have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.
- •Not enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- •Not be able to read, write and comprehend English
- •Younger than 18 years of age.
- •Not capable of completing measures
- •Not capable of indicating pain intensity,
- •Not capable of filling out study measures,
- •Extreme susceptibility to motion sickness,
- •Seizure history,
- •Unusual sensitivity or lack of sensitivity to pain,
- •Sensitive skin,
- •Sensitive feet
- •Migraines
- •The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.
- •COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).
- •All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.
- •If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study.
结局指标
主要结局
Worst pain, baseline, participant's rating of "worst pain" during baseline measure
时间窗: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Baseline, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
participant's rating of "worst pain" during test phase
时间窗: Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)
Test phase, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
次要结局
- Baseline, participants rating of "Fun" during baseline(Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim))
- Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuli(Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim))
- Baseline, participants rating of "time spent thinking about pain"(Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim))
- Test phase, participants rating of "pain unpleasantness" during test phase(Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating))
- Test Phase, participants rating of "time spent thinking about pain" during test phase(Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating))
- Test Phase, participants ratings of "Fun" during test phase(Immediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating))
- Baseline, participants rating of "pain unpleasantness"(Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim))
- Accuracy on the odd number task during No VR, Low tech VR and High tech VR(No pain during this measure, measured within 10 minutes after the QST measures are completed.)
研究者
Hunter Hoffman
Affiliate Assistant Professor, Psychology
University of Washington
研究点 (2)
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