Pain and Music Therapy in Patients Suffering Arteritis (Musicthérapy)

March 24, 2011 updated by: University Hospital, Limoges

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music therapy group
Local care with music
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Marc LASKAR, MD, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2011

Last Update Submitted That Met QC Criteria

March 24, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I09022 / musicthérapy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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