RecruitingNot ApplicableNCT06153589

Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study

Sponsor

University Hospital Center of Martinique

Enrollment

180 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Leg Ulcer Debridement Care Leg Ulcers Venous

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Adult patient,
Patient followed at the M@diCICAT healing center requiring wound debridement :
For a venous or arterial ulcer or necrotizing angiodermatitis of the lower limbs,
Having the ability to verbalize about their pain (communicating),
With a planned debridement time of less than 40 minutes.
Patient affiliated to or beneficiary of a social security scheme,
Patient having given free, informed and express consent.

Exclusion Criteria8

Patient with a diabetic foot (loss of sensitivity-neuropathy),
Patient not requiring a debridement session,
Patient with an infected ulcer (abscess, etc.),
Patient with critical ischemia,
Patient with hearing problems,
Patient with cognitive disorders,
Patient placed under legal protection, guardianship or curatorship,
Pregnant or breastfeeding woman.

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Interventions

OTHERMusicotherapy

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.