Using music therapy to reduce pain from leg ulcer care
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
NA · University Hospital Center of Martinique · NCT06153589
This study tests if music therapy can help reduce pain for adults getting treatment for leg ulcers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Center of Martinique (other) |
| Locations | 1 site (Fort-de-France) |
| Trial ID | NCT06153589 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of music therapy in alleviating pain associated with the care of venous leg ulcers, particularly during the debridement process. The intervention employs a standardized U-shaped music therapy method, which has previously shown promise in reducing pain and anxiety in various medical settings. Participants will be adult patients requiring debridement for venous or arterial ulcers at the M@diCICAT healing center, and their pain levels will be assessed before and after the intervention. The study aims to improve the quality of life for patients suffering from chronic venous disease and its complications.
Who should consider this trial
Good fit: Ideal candidates are adults requiring debridement for venous or arterial ulcers who can communicate their pain levels.
Not a fit: Patients with diabetic foot, infected ulcers, critical ischemia, hearing problems, cognitive disorders, or those under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall experience of patients undergoing leg ulcer care.
How similar studies have performed: Previous studies have shown success with music therapy in various medical fields, suggesting potential effectiveness in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fort-de-France
- University Hospital Center of Martinique — Fort-de-France, France (RECRUITING)
Study contacts
- Principal investigator: Emmanuelle Guitteaud — University Hospital Center of Martinique
- Study coordinator: Emmanuelle Guitteaud
- Email: emmanuelle.guitteaud@chu-martinique.fr
- Phone: 05 96 55 35 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Debridement Care, Leg Ulcer, Leg Ulcers Venous, Pain, Debridement, Venous leg ulcer