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OpenTrials
Completed

NCT Number: NCT01323504

Pain and Music Therapy in Patients Suffering Arteritis

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.

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Key information

Conditions

Arteritis Cardiovascular Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Limoges

Limoges, France, 87 042

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

Patient are listen music during their local care

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: Musicthérapy

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 25, 2011
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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