Pain and Music Therapy in Patients Suffering Arteritis
Musicthérapy
Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
1 other identifier
interventional
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 25, 2011
March 1, 2011
1.5 years
March 15, 2011
March 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief during local care with music or not.
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.
7 days
Secondary Outcomes (1)
Quantification in equivalent morphine of the analgesic prescription at the seventh day
7 days
Study Arms (2)
Music therapy group
EXPERIMENTALLocal care with music
control group
NO INTERVENTIONLocal care without music
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc LASKAR, MD
University Hospital, Limoges
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 25, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
March 25, 2011
Record last verified: 2011-03