Pain and Music Therapy in Patients Suffering Arteritis

Arteritis Clinical Trial

— Musicthérapy  

Official title:

Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01323504
• Other study ID #: I09022 / musicthérapy
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 15, 2011
• Last updated: March 24, 2011
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2011
• Source: University Hospital, Limoges
• Contact: Marc LASKAR, MD
• Phone: 0555056385
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arteritis

Intervention

Other:
• Music
Patient are listen music during their local care
• no music
There are no music during the local care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quantification in equivalent morphine of the analgesic prescription at the seventh day	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.	7 days	No