An interventional study of Music and pain in Acute Pain, sponsored by Eske Kvanner Aasvang. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Eske Kvanner Aasvang · Not applicable, Interventional, and Basic science
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.
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.
Following the wash-out period the participants will return to another BrAC measurement followed by an identical CPT. However, this time they will listen to the opposite song than before. The investigators will expect that the participants will have a different alcohol concentration in the breath (higher/lower) for the second pain test.
The investigators will include up to 45 participants.
Explanation of Cold Pressor Test:
The CPT is performed with a cold-water bath with a temperature of 4° - 5° degrees cold circulating water. The participant will be asked to submerge their dominant hand and wrist in the cold water and a timer will be started simultaneously. Participants are asked to keep the hand in the water until pain threshold and pain tolerance is reached. Participants are allowed to move the hand or keep it still as they wish, and they are informed that there will be a time cap of 5 minutes to ensure no permanent damage.
The water will be circulated with an Eheim 1046 universal pump (Eheim, Deizisau, Germany), and temperature monitored with a Testo 925 waterproof precision thermometer (Testo, Lenzkirch, Germany). The CPT setup is identical to a prior study performed by the same author.
Prior to stimulation the participants will be thoroughly informed of the procedure by an investigator using the instructions of a previous study.
Exclusion Criteria:
Pull-out criteria
In this arm, participants will listen to Enya in headphones while being exposed to the Cold Pressor Test.
Combination Product: Music and pain
In this arm, participants will listen to Slayer in headphones while being exposed to the Cold Pressor Test.
Combination Product: Music and pain
In both arms of the study the participant will take the same pain test. They will either listen to Enya or slayer, depending on the arm
pain responsiveness
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
Time frame: 300 seconds
pain threshold and pain tolerance
Pain threshold is measured as the number of seconds passed from the beginning of the pain stimulation till the participant says "pain", when stimulus evolves from being unpleasant to painful. Pain tolerance is measured as the number of seconds passed from the beginning of pain stimulation till the participant can't bear the pain anymore and says "pain limit".
Time frame: five minutes
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Eske Kvanner Aasvang