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Pain and Music Therapy in Patients Suffering Arteritis

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01323504
Acronym
Musicthérapy
Enrollment
25
Registered
2011-03-25
Start date
2011-06-15
Completion date
2015-12-12
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteritis

Keywords

Stage 5 arteritis, Stage 6 arteritis, rutherford classification

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.

Interventions

OTHERMusic

Patient are listen music during their local care

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain relief during local care with music or not.7 daysDifferent 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

MeasureTime frameDescription
Quantification in equivalent morphine of the analgesic prescription at the seventh day7 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarc LASKAR, MD

University Hospital, Limoges

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026