Clinical trial NCT06153589: Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care
Official title: Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Debridement Care
Leg Ulcer
Leg Ulcers Venous
Pain
Keywords: Debridement
Venous leg ulcer
Pain
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Music Care
First posted: 2023-12-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: To evaluate the effectiveness of "U" musicotherapy in the management of pain induced by debridement in patients with chronic wounds of the lower limb
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: To evaluate the variation of blood pressure before and after debridement treatment on a chronic wound of the lower limb.
timeFrame: 18 months
measure: To evaluate the variation of heart rate before and after debridement treatment on a chronic wound of the lower limb.
timeFrame: 18 months
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: University Hospital Center of Martinique
Study officials:
affiliation: University Hospital Center of Martinique
name: Emmanuelle Guitteaud
role: PRINCIPAL_INVESTIGATOR
References: