Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Center of Martinique

About this trial

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 criteria

Qualifiers

Adult patient,

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.

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Musicotherapy

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University Hospital Center of MartiniqueRecruiting97261, Fort-de-FranceFranceFrance

Sponsors and collaborators