Debridement CareMUS-ICATNCT06153589
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care
A study testing Musicotherapy in people with Debridement Care and Leg Ulcer, run by University Hospital Center of Martinique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Debridement Care, Leg Ulcer, Leg Ulcers Venous
- What is being tested?
- Musicotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Center of Martinique
Fort-de-France, 97261
Yann Mopsus, MSc, yann.mopsus@chu-martinique.fr
About this study
Official title: Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
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.
Read more
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
- Being tested
- Musicotherapy
- Keywords
- Debridement, Venous leg ulcer, Pain
- Medical subject headings
- Leg Ulcer, Varicose Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Consumption of analgesics during and after debridement (Level 1-2 or 3, route, dosage, frequency).
Measured: 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.
Variation in anxiety according to the VAS anxiety scale, (VAS anxiety 10 min after debridement) - (VAS anxiety 10 min before debridement). The anxiety VAS will be collected at the two times according to the patient's assessment.
Measured: 18 months
To evaluate the variation of blood pressure before and after debridement treatment on a chronic wound of the lower limb.
Blood pressure variation before and after debridement.
Measured: 18 months
To evaluate the variation of heart rate before and after debridement treatment on a chronic wound of the lower limb.
Heart rate variation before and after debridement.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start8 Jan 2025
- Primary completion8 Jul 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Debridement CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Music Care
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Guitteaud, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153589
- Sponsor's protocol ID
- 23_RIPH2-10
- Acronym
- MUS-ICAT
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2023
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study
- ClinicalTrials.gov ID
- NCT06153589
- Acronym / sponsor ID
- MUS-ICAT / 23_RIPH2-10
- Conditions
- Debridement Care, Leg Ulcer, Leg Ulcers Venous, Pain
- Keywords
- Debridement, Venous leg ulcer, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Music Care
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 8 Jul 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Musicotherapy + debridement and usual analgesic protocol | Experimental | Other: MusicotherapyPatients 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. |
| Debridement and usual analgesic protocol | No intervention | –Patients in the experimental arm will receive classic debridement care and usual use of analgesic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient,
- Patient followed at the M@diCICAT healing center requiring wound debridement :
- Patient affiliated to or beneficiary of a social security scheme,
- Patient having given free, informed and express consent.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicotherapyMusicotherapy 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. | Other | Musicotherapy + debridement and usual analgesic protocol |
Primary outcome
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
Variation in physical pain assessed by VAS (Visual Analogue Scale from 0 to 10)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuelle Guitteaud principal investigator
University Hospital Center of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musicotherapy in people with Debridement Care and Leg Ulcer, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle Guitteaud (05 96 55 35 45 ext. +596, emmanuelle.guitteaud@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2025.