Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

NCT06153589 | Recruiting DMC

• 1 other identifier: 23_RIPH2-10
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of "U" musicotherapy in the management of pain induced by debridement in patients with chronic wounds of the lower limb

  Variation in physical pain assessed by VAS (Visual Analogue Scale from 0 to 10)

  18 months

Secondary Outcomes (4)

• To evaluate the effectiveness of "U" music therapy in reducing the consumption of analgesics during and after debridement treatment on a chronic wound of the lower limb.

  18 months

• To evaluate the effectiveness of "U" music therapy in the variation of anxiety induced by debridement in patients with chronic wounds of the lower limb.

  18 months

• To evaluate the variation of blood pressure before and after debridement treatment on a chronic wound of the lower limb.

  18 months

• To evaluate the variation of heart rate before and after debridement treatment on a chronic wound of the lower limb.

  18 months

Study Arms (2)

Musicotherapy + debridement and usual analgesic protocol

EXPERIMENTAL

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.

Other: Musicotherapy

Debridement and usual analgesic protocol

NO INTERVENTION

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

Interventions

Musicotherapy 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.

Musicotherapy + debridement and usual analgesic protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Music Care: collaborator

Study Sites (1)

University Hospital Center of Martinique

Fort-de-France, 97261, France

RECRUITING

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer; Pain

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuelle Guitteaud

  University Hospital Center of Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle Guitteaud

CONTACT

05 96 55 35 45; emmanuelle.guitteaud@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 1, 2023
• Study Start: January 8, 2025
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: March 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)