RecruitingNAINTERVENTIONAL

Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

This study investigates if listening to music can reduce pain for people needing their leg ulcers cleaned. Leg ulcers, often caused by poor circulation, can be painful, especially during common procedures like debridement (removing unhealthy tissue). Current pain relief might not always be enough for this. Researchers want to see if a specific, tested music therapy method, delivered via a digital app, can make the cleaning process less painful. This study aims to fill a gap, as music therapy hasn't been specifically studied for leg ulcer debridement before. It's for adults with certain types of leg ulcers, without other complicating health issues.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Center of Martinique

Enrolment target

180

Start

08 Jan 2025

Estimated completion

08 Sep 2026

Debridement Care Leg Ulcer Leg Ulcers Venous Pain

What is this study about?

This study is exploring a way to help people with leg ulcers feel less pain during a common treatment called debridement. If you have a leg ulcer, it means you have a sore on your leg that might be caused by problems with your blood flow. These ulcers can sometimes be quite painful, and part of caring for them involves cleaning the wound and removing any unhealthy tissue. This cleaning process, called debridement, can sometimes hurt, even if you've taken pain relief beforehand.

Researchers are interested in a technique called music therapy, which uses music in a structured way to help with various conditions, including pain and anxiety. A specific method of music therapy has shown promising results in other areas, and it can now be delivered through a special app. This study wants to find out if using this music therapy during leg ulcer debridement can make the procedure more comfortable and reduce your pain.

Finding better ways to manage pain during treatments is important because it can make the experience easier for patients and improve their overall quality of life. Even though music therapy has been studied for pain in many other situations, it hasn't been specifically looked at for leg ulcer debridement, so this study aims to see if it could be a helpful option.

Key takeaways

This study explores using music to reduce pain during leg ulcer cleaning.
It uses a special music therapy app, which is a certified medical device.
The aim is to make a common, sometimes painful, procedure more comfortable.
It's for adults with certain types of leg ulcers who can talk about their pain.
Participation involves listening to music during your planned wound cleaning session.

Who may be eligible?

This study is looking for adult volunteers who have a leg ulcer and need to have it cleaned (debridement) at the M@diCICAT healing center. You must be able to talk about your pain and the cleaning session should ideally be planned for less than 40 minutes.

Some people won't be able to join the study. This includes if you have a leg ulcer due to diabetes with a loss of feeling in your feet, an infected ulcer, or severe blood flow problems in your leg. Also, if you have significant hearing problems, memory issues, or are pregnant or breastfeeding, you won't be able to take part. This ensures the study is safe and the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Do you have a leg ulcer that needs cleaning at the M@diCICAT center?
Can you clearly talk about the pain you feel?
Do you have a different type of leg ulcer than a diabetic foot ulcer or an infected ulcer?
Do you have good hearing and no memory problems?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue with your planned leg ulcer debridement (cleaning) session at the M@diCICAT healing center. During this procedure, you would listen to specific music through a special app. The researchers would then ask you about your pain levels to see if the music helped. The exact number of visits isn't specified, but it would involve participating during your scheduled debridement appointment. There are no special medications involved, just the music therapy, and the total duration of your involvement would primarily be during that one cleaning session.

Potential risks and benefits

Participating in this study might offer the benefit of reduced pain during your leg ulcer cleaning session, potentially making a necessary procedure more comfortable. While music therapy is generally considered safe, there are no notable risks mentioned beyond the standard procedure itself. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Center of Martinique
City only
Fort-de-France, France· Recruiting

Common questions

What is debridement?

Debridement is a procedure where unhealthy tissue is removed from a wound, like a leg ulcer, to help it heal better. It's a common and important part of wound care.

What is music therapy?

Music therapy uses music delivered in a structured way to help with different problems, such as reducing pain or anxiety. It's more than just casually listening to music.

Why is this study important?

Cleaning leg ulcers can sometimes be painful. This study wants to see if music therapy can safely and effectively reduce that pain, making the treatment more comfortable for patients.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. Your affiliation with a social security scheme is mainly for administrative purposes related to healthcare in general.

What if I don't like the music?

The study uses a specific, standardized music sequence designed for pain relief. While personal preference varies, the focus is on its therapeutic effect. You can always discuss any concerns with the study team.

How to find out more

Emmanuelle Guitteaud

emmanuelle.guitteaud@chu-martinique.fr 05 96 55 35 45 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.