Musicthérapy: Pain and Music Therapy in Patients Suffering Arteritis

Sponsor
University Hospital, Limoges (Other)
Overall Status
Unknown status
CT.gov ID
NCT01323504
Collaborator
(none)
58
2
20

Study Details

Study Description

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
  • Other: Music
  • Other: no music
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2011
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pain relief during local care with music or not. [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

  • Principal Investigator: Marc LASKAR, MD, University Hospital, Limoges

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01323504
Other Study ID Numbers:
  • I09022 / musicthérapy
First Posted:
Mar 25, 2011
Last Update Posted:
Mar 25, 2011
Last Verified:
Mar 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2011