Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471985
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Brief Title:
CoPainHell The Analgesic Effect of Alcohol and Music
Sponsor:
Eske Kvanner Aasvang
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
CoPainHell The Analgesic Effect of Alcohol and Music
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPH
Brief 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 The intervention involves a cold water test where the participants 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
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 higherlower 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
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 higherlower 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None