Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Limoges.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01323504
First received: March 15, 2011
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Arteritis
Other: Music
Other: no music
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Pain relief during local care with music or not. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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:
  • Quantification in equivalent morphine of the analgesic prescription at the seventh day [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 58
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323504

Contacts
Contact: Marc LASKAR, MD 0555056385

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

No publications provided

Responsible Party: Marc LASKAR, CHU de Limoges
ClinicalTrials.gov Identifier: NCT01323504     History of Changes
Other Study ID Numbers: I09022 / musicthérapy
Study First Received: March 15, 2011
Last Updated: March 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Arteritis
Stress, Psychological
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 31, 2014