Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

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

Interventions

OTHER

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.

Sponsors & Collaborators

• Music Care

  collaborator UNKNOWN

• University Hospital Center of Martinique

  lead OTHER

Principal Investigators

• Emmanuelle Guitteaud · University Hospital Center of Martinique

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-08

Primary Completion

2026-07-08

Completion

2026-09-08

Countries

• France