Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153589
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-11-13
Brief Title:
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care
Sponsor:
University Hospital Center of Martinique
Organization:
University Hospital Center of Martinique
Study Overview
Official Title:
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care a Randomized Controlled Open-label Parallel-arm Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
MUS-ICAT
Brief Summary:
Venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency The problems caused by venous disease are initially minor and often neglected but can impact the quality of life of patients
The prevalence of leg ulcers is estimated at 1 of the general population and 3 to 5 of subjects over 65 years old Its prevalence increases with age in both men and women
Managing chronic ulcers requires a certain number of care procedures including debridement
The act of treatment by mechanical debridement is little relieved by the analgesics given beforehand and can be painful with risks of bleeding
Musicotherapy particularly the U-shaped method has shown its effectiveness in the treatment of pain and anxiety in several areas geriatrics intensive care rheumatology oncology etc
The standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 Pr Jacques Touchon Dr Stéphane Guétin
Following the publication of numerous controlled randomized studies presenting results on the effectiveness in the treatment of pain and anxiety a digital application was developed in order to standardize the method The Music Care health application is now a Class 1 Medical Device with CE marking obtained
This U-shaped sequence is standardized and has been clinically validated which makes Music Care a unique tool available for pain relief
No studies have been found in the literature regarding the use of music therapy during debridement care
The prevalence of leg ulcers is estimated at 1 of the general population and 3 to 5 of subjects over 65 years old Its prevalence increases with age in both men and women
Managing chronic ulcers requires a certain number of care procedures including debridement
The act of treatment by mechanical debridement is little relieved by the analgesics given beforehand and can be painful with risks of bleeding
Musicotherapy particularly the U-shaped method has shown its effectiveness in the treatment of pain and anxiety in several areas geriatrics intensive care rheumatology oncology etc
The standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 Pr Jacques Touchon Dr Stéphane Guétin
Following the publication of numerous controlled randomized studies presenting results on the effectiveness in the treatment of pain and anxiety a digital application was developed in order to standardize the method The Music Care health application is now a Class 1 Medical Device with CE marking obtained
This U-shaped sequence is standardized and has been clinically validated which makes Music Care a unique tool available for pain relief
No studies have been found in the literature regarding the use of music therapy during debridement care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None