Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Pain relief during local care with music or not.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
control group
Coutrol group
Intervention: no music (Other)
Music therapy group
Local care with music
Intervention: Music (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Quantification in equivalent morphine of the analgesic prescription at the seventh day(7 days)