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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
University Hospital Center of Martinique
RECRUITING
Fort-de-france
Contact Information
Primary
Emmanuelle Guitteaud
emmanuelle.guitteaud@chu-martinique.fr
05 96 55 35 45
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2026-09-08
Participants
Target number of participants: 180
Treatments
Experimental: Musicotherapy + debridement and usual analgesic protocol
Patients in the experimental arm will receive classic debridement care and usual use of analgesic treatment, accompanied by a musicotherapy session respecting the standardized method of the U-shaped sequence.
No_intervention: Debridement and usual analgesic protocol
Patients in the experimental arm will receive classic debridement care and usual use of analgesic treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Music Care
Leads: University Hospital Center of Martinique

This content was sourced from clinicaltrials.gov