Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

NCT ID: NCT06153589

Last Updated: 2025-03-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-09-08

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.

Conditions

Debridement Care; Leg Ulcer; Leg Ulcers Venous; Pain

Keywords

Debridement; Venous leg ulcer; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Musicotherapy

Intervention Type: OTHER

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.

Debridement and usual analgesic protocol

Patients in the experimental arm will receive classic debridement care and usual use of analgesic treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Musicotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Music Care

UNKNOWN

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle Guitteaud

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Martinique

Locations

University Hospital Center of Martinique

Fort-de-France, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emmanuelle Guitteaud

Role: CONTACT

Phone: 05 96 55 35 45

Email: emmanuelle.guitteaud@chu-martinique.fr

Facility Contacts

Yann Mopsus, MSc

Role: primary

Other Identifiers

23_RIPH2-10

Identifier Type: -

Identifier Source: org_study_id