Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Musicotherapy.
- Who it may be relevant to
- Registry conditions: Debridement Care, Leg Ulcer, Leg Ulcers Venous, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
Overview
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.
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
Primary outcome measures
- To evaluate the effectiveness of "U" musicotherapy in the management of pain induced by debridement in patients with chronic wounds of the lower limb [Time frame: 18 months]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 18 months]
- To evaluate the variation of blood pressure before and after debridement treatment on a chronic wound of the lower limb. [Time frame: 18 months]
- To evaluate the variation of heart rate before and after debridement treatment on a chronic wound of the lower limb. [Time frame: 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- University Hospital Center of Martinique — Fort-de-France
Identifiers
NCT: NCT06153589 · 23_RIPH2-10