Pain and Music Therapy in Patients Suffering Arteritis

Study Overview
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Brief Summary
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It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD), of whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation, the patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is generally associated with increasing pain. Pain relief may be challenging in spite of major analgesics. Several studies in this country and elsewhere assessed the usefulness of music for chronic or acute pain relief during care. However, no data are published regarding the interest of music therapy for pain relief during local care in PAD patients.

Official Title
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Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.

Conditions
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Arteritis

Intervention / Treatment
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* Other: Music
* Other: no music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, aged at least 18 years, affiliated to the health insurance scheme. Patients affected by arteritis of stage 5 or 6 at Limoges University Hospital in department cardiovascular Surgery. Patients requiring a daily repair of bandage, not exceeding fifteen minutes and provoking a pain Initial pain equal to three during local care in the digital scale. Having given their enlightened consent writes Exclusion Criteria: Bypass and / or angioplasty lower than one week Diabetic neuropathy Patient who is going to undergo a surgery of amputation Patients affected by demented pathologies or by confusion Pregnant or breast-feeding women or without effective contraception Patients being the object of a saving of justice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy group<br>Local care with music | Other: Music<br>* Patient are listen music during their local care<br>|
| No Intervention: control group<br>Local care without music | Other: no music<br>* There are no music during the local care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief during local care with music or not. | Different level of pain front-counterpart realization of the bandage which will be compared between both groups of patients in the seventh day after implementation of the procedure. The level of pain will be measured by a digital scale from 0 to 10. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification in equivalent morphine of the analgesic prescription at the seventh day | Quantification in equivalent morphine of the analgesic prescription at the seventh day after implementation of the musicotherapy Pain intensity during the bandage at the seventh day measured by digital scale from 0 to 10. anxiety intensity at the seventh day measured by scale HAD after implementation of the musicotherapy. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage 5 arteritis, Stage 6 arteritis, rutherford classification