Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)
|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
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|
|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|
Experimental: Music therapy group
Local care with 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323504
|Contact: Marc LASKAR, MD||0555056385|
|Principal Investigator:||Marc LASKAR, MD||University Hospital, Limoges|