Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)
Recruitment status was: Not yet recruiting
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.
|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.|
- 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.
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323504
|Principal Investigator:||Marc LASKAR, MD||University Hospital, Limoges|