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Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)

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ClinicalTrials.gov Identifier: NCT01323504
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Limoges.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
Information provided by:
University Hospital, Limoges

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Arteritis Other: Music Other: no music Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
Study Start Date : April 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Music therapy group
Local care with music
Other: Music
Patient are listen music during their local care
No Intervention: control group
Local care without music
Other: no music
There are no music during the local care

Primary Outcome Measures :
  1. Pain relief during local care with music or not. [ Time Frame: 7 days ]
    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.

Secondary Outcome Measures :
  1. Quantification in equivalent morphine of the analgesic prescription at the seventh day [ Time Frame: 7 days ]
    • 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323504

Contact: Marc LASKAR, MD 0555056385

Sponsors and Collaborators
University Hospital, Limoges
Principal Investigator: Marc LASKAR, MD University Hospital, Limoges

Responsible Party: Marc LASKAR, CHU de Limoges
ClinicalTrials.gov Identifier: NCT01323504     History of Changes
Other Study ID Numbers: I09022 / musicthérapy
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011

Keywords provided by University Hospital, Limoges:
Stage 5 arteritis
Stage 6 arteritis
rutherford classification

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases