Pain and Music Therapy in Patients Suffering Arteritis

NCT ID: NCT01323504

Last Updated: 2011-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Arteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Music therapy group

Local care with music

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Patient are listen music during their local care

control group

Local care without music

Group Type NO_INTERVENTION

no music

Intervention Type OTHER

There are no music during the local care

Interventions

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Music

Patient are listen music during their local care

Intervention Type OTHER

no music

There are no music during the local care

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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CHU de Limoges

Principal Investigators

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Marc LASKAR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Central Contacts

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Marc LASKAR, MD

Role: CONTACT

0555056385

Other Identifiers

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I09022 / musicthérapy

Identifier Type: -

Identifier Source: org_study_id

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