CoPainHell: The Analgesic Effect of Alcohol and Music
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- pain responsiveness
研究概览
简要总结
The study is a 2x2 randomized crossover study. Participants are randomized to listen to one of two music tracks: "Orinoco Flow" by Enya or "Raining Blood" by Slayer. Prior to the intervention, participants' breath alcohol levels are measured through a breathalyzer test. The intervention involves a cold water test, where the participant's dominant hand is submerged in water at 4-5 degrees Celsius. Participants are instructed to keep their hand in the water until the pain becomes too intense, but no longer than 5 minutes.
Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than they did during the first test. Participants receive no instructions on how to behave during the 2-hour interval.
The experiment takes place during the music festival CopenHell (June 19-22, 2024), provided that there is approval from relevant authorities.
Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than in the first test. Participants are given no instructions on how to behave during the 2-hour interval.
详细描述
This study is a 2x2 factorial randomized cross-over study investigating the effect of alcohol and music on analgesia. Enrollment will be at the Festival Site of Copenhell, Refshalevej 185, 1432 København K, Denmark. Participants meeting inclusion criteria will be enrolled.
Following the written and oral informed consent to participate in the trial, participants will fill out a questionnaire of demographics information.
When performing the intervention, participants will initially have their blood alcohol content measured with a breath analyzer measuring Breath Alcohol Content (BrAC). After BrAC measurement, the study participants will undergo ''cold pressor test'' (CPT) pain stimulation on their dominant arm:
Prior to the CPT, the participants will be randomized to either listening to the calm and relaxing song "Orinoco Flow" by Enya or the song "Raining Blood" by Slayer, considered one of the most iconic heavy-metal music numbers, during the test.
After the pain stimulation test the participants will undergo a wash out period lasting at least 2 hours where participants enjoy the festival on their own without any instructions.
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)
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
- •Participants ≥ 18 years old
- •Informed consent
- •Breath alcohol concentration ranging from 0.0 to 1.5 permille and deemed fit by the investigator at the time of giving informed consent
排除标准
- •Wounds on dominant arm
- •Current illness (a flu, cold etc.)
- •Persons with diabetes because of the risk of peripheral neuropathies or other know peripheral sensibility paresthesia
- •Circulation issues (especially Raynaud's syndrome)
- •Pregnancy
- •Pull-out criteria
- •Breath alcohol concentration > 2.5 permille and/or deemed unfit to participate by the investigator at the second pain test
结局指标
主要结局
pain responsiveness
时间窗: 300 seconds
Pain responsiveness will be measured on the VAS, where an investigator will ask the participants to rate their experienced pain from 1-10. The VAS will be rated at the start of CPT + 30 seconds, 60 seconds, 90, 120, 180, 240 and 300 seconds or when reaching the pain tolerance (up to 5 minutes), where the test will end whichever comes first. VAS: Visuel Analog Scale. Values 0-10, where 0 is no pain at al and 10 is the worst pain imaginable
次要结局
- pain threshold and pain tolerance(five minutes)
研究者
Eske Kvanner Aasvang
Professor
Rigshospitalet, Denmark