ArteritisMusicthérapyNCT01323504
Pain and Music Therapy in Patients Suffering Arteritis
A study testing Music in people with Arteritis, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteritis
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2011to 12 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arteritis
- Being tested
- Music
- Keywords
- Stage 5 arteritis, Stage 6 arteritis, rutherford classification
- Medical subject headings
- Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Patient are listen music during their local care
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | Local care with music Receives: Other: Music |
| control group | No intervention | Coutrol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study start15 Jun 2011
- Primary completion6 Aug 2014
- Study completion12 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LASKAR, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323504
- Sponsor's protocol ID
- I09022 / musicthérapy
- Acronym
- Musicthérapy
- Status last verified
- Jun 2016
- First submitted
- 15 Mar 2011
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
- ClinicalTrials.gov ID
- NCT01323504
- Acronym / sponsor ID
- Musicthérapy / I09022 / musicthérapy
- Conditions
- Arteritis
- Keywords
- Stage 5 arteritis, Stage 6 arteritis, rutherford classification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 15 Jun 2011 (actual)
- Primary completion
- 6 Aug 2014 (actual)
- Study completion
- 12 Dec 2015 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Other: MusicLocal care with music |
| control group | No intervention | –Coutrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicPatient are listen music during their local care | Other | Music therapy group |
Primary outcome
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.
1 secondary outcome
Quantification in equivalent morphine of the analgesic prescription at the seventh day
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
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Reducing Arterial Inflammation Using Eplerenone and Statins in HIV
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The Applanation Tonometry in GCA Pilot
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc LASKAR, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Arteritis, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief during local care with music or not. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.