University Hospital Center of Martinique
Fort-de-France, 97261, France
Location status: Recruiting
NCT Number: NCT06153589
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Fort-de-France, 97261, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Musicotherapy will be offered to patients who meet the eligibility criteria, and have been randomized to the experimental arm.
Patients will only be seen once during the study. Patients are placed in individual rooms. Hifi audio headphones (equipped with hygienic earcups) and a tablet equipped with the Music Care application will be offered to patients in the experimental group and the investigators will help them choose the style of music, which respects the U-shaped sequence.
The Music Care application has proven that the use of headphones allows the patient to be isolated and therefore to obtain less parasitic care. He will be told at the start of the session that he can ask to interrupt it if he wishes to communicate with the team, particularly regarding possible pain.
The musicotherapy session begins before the act of debridement (10 minutes before), lasts during the act (40 minutes maximum), and continues for 10 minutes after the end of the debridement.
Time frame: 18 months
Variation in physical pain assessed by VAS (Visual Analogue Scale from 0 to 10)
Time frame: 18 months
Consumption of analgesics during and after debridement (Level 1-2 or 3, route, dosage, frequency).
Time frame: 18 months
Variation in anxiety according to the VAS anxiety scale, (VAS anxiety 10 min after debridement) - (VAS anxiety 10 min before debridement). The anxiety VAS will be collected at the two times according to the patient's assessment.
Time frame: 18 months
Blood pressure variation before and after debridement.
Time frame: 18 months
Heart rate variation before and after debridement.
Contact information is provided by the study sponsor or research team.
University Hospital Center of Martinique
Other
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
Acronym: MUS-ICAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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