Acute PainCPHNCT06471985
CoPainHell: The Analgesic Effect of Alcohol and Music
A study testing Music and pain in people with Acute Pain, run by Eske Kvanner Aasvang at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Music and pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Pain
- Being tested
- Music and pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and painCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Enya + Pain test | Active comparator | In this arm, participants will listen to Enya in headphones while being exposed to the Cold Pressor Test. Receives: Combination Product: Music and pain |
| Slayer + Pain test | Active comparator | In this arm, participants will listen to Slayer in headphones while being exposed to the Cold Pressor Test. Receives: Combination Product: Music and pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 300 seconds
Secondary outcomes (1)
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".
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start19 Jun 2024
- Primary completion22 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471985
- Sponsor's protocol ID
- CPH_2024
- Acronym
- CPH
- Status last verified
- Apr 2025
- First submitted
- 18 Jun 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoPainHell: The Analgesic Effect of Alcohol and Music
- ClinicalTrials.gov ID
- NCT06471985
- Acronym / sponsor ID
- CPH / CPH_2024
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enya + Pain test | Active comparator | Combination Product: Music and painIn this arm, participants will listen to Enya in headphones while being exposed to the Cold Pressor Test. |
| Slayer + Pain test | Active comparator | Combination Product: Music and painIn this arm, participants will listen to Slayer in headphones while being exposed to the Cold Pressor Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and painIn 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 | Combination product | Enya + Pain test, Slayer + Pain test |
Primary outcome
pain responsiveness
Time frame: 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
1 secondary outcome
pain threshold and pain tolerance
Time frame: five minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske K Aasvang principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and pain in people with Acute Pain, run by Eske Kvanner Aasvang at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain responsiveness (time frame: 300 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.