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CompletedNCT01323504MusicthérapyUpdated Jun 24, 2026

Pain and Music Therapy in Patients Suffering Arteritis

An interventional study of Music in Arteritis, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arteritis

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Keywords

  • Stage 5 arteritis
  • Stage 6 arteritis
  • rutherford classification
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Music therapy group

    Local care with music

    Other: Music

  • No intervention
    control group

    Coutrol group

Interventions

  • OtherMusic

    Patient are listen music during their local care

05

What researchers measure

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.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 7 days

06

Study locations

1 site
  • CHU Limoges
    Limoges, France 87 042, France
07

Registry details

Key details

Study ID
NCT01323504
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Mar 25, 2011
Start date
Jun 15, 2011
Primary completion
Aug 6, 2014
Completion
Dec 12, 2015
Last update
Jun 24, 2026

Study contacts

Marc LASKAR, MD
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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