NCT01323504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2015

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2016

Enrollment Period

3.1 years

First QC Date

March 15, 2011

Last Update Submit

June 23, 2026

Conditions

Arteritis

Keywords

Stage 5 arteritisStage 6 arteritisrutherford classification

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quantification in equivalent morphine of the analgesic prescription at the seventh day

    7 days

Study Arms (2)

Music therapy group

EXPERIMENTAL

Local care with music

Other: Music

control group

NO INTERVENTION

Coutrol group

Interventions

MusicOTHER

Patient are listen music during their local care

Music therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Limoges

Limoges, France, 87 042, France

Location

MeSH Terms

Conditions

Arteritis

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marc LASKAR, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 25, 2011

Study Start

June 15, 2011

Primary Completion

August 6, 2014

Study Completion

December 12, 2015

Last Updated

June 24, 2026

Record last verified: 2016-06

Locations

FR(1)