Pain and Music Therapy in Patients Suffering Arteritis

Phase 3

• Conditions: Arteritis
• Interventions: Other: Music; Other: no music

• Registration Number: NCT01323504
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-24
• Last Update Submitted: 2011-03-24
• Study First Posted: 2011-03-25
• Last Update Posted: 2011-03-25
• Study Start: 2011-04
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy group	Music	Local care with music
control group	no music	Local care without music

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.