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Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)

U

University of Limoges (UL)

Status and phase

Unknown
Phase 3

Conditions

Arteritis

Treatments

Other: Music
Other: no music

Study type

Interventional

Funder types

Other

Identifiers

NCT01323504
I09022 / musicthérapy

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

58 participants in 2 patient groups

Music therapy group
Experimental group
Description:
Local care with music
Treatment:
Other: Music
control group
No Intervention group
Description:
Local care without music
Treatment:
Other: no music

Trial contacts and locations

0

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Central trial contact

Marc LASKAR, MD

Data sourced from clinicaltrials.gov

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