Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01323504
Status:
UNKNOWN
Last Update Posted:
2011-03-25
First Post:
2011-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain and Music Therapy in Patients Suffering Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001167', 'term': 'Arteritis'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-24', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief during local care with music or not.', 'timeFrame': '7 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Quantification in equivalent morphine of the analgesic prescription at the seventh day', 'timeFrame': '7 days', 'description': '* Quantification in equivalent morphine of the analgesic prescription at the seventh day after implementation of the musicotherapy\n* Pain intensity during the bandage at the seventh day measured by digital scale from 0 to 10.\n* anxiety intensity at the seventh day measured by scale HAD after implementation of the musicotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stage 5 arteritis', 'Stage 6 arteritis', 'rutherford classification'], 'conditions': ['Arteritis']}, 'descriptionModule': {'briefSummary': '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.\n\nSeveral 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, aged at least 18 years, affiliated to the health insurance scheme.\n* Patients affected by arteritis of stage 5 or 6 at Limoges University Hospital in department cardiovascular Surgery.\n* Patients requiring a daily repair of bandage, not exceeding fifteen minutes and provoking a pain\n* Initial pain equal to three during local care in the digital scale.\n* Having given their enlightened consent writes\n\nExclusion Criteria:\n\n* Bypass and / or angioplasty lower than one week\n* Diabetic neuropathy\n* Patient who is going to undergo a surgery of amputation\n* Patients affected by demented pathologies or by confusion\n* Pregnant or breast-feeding women or without effective contraception\n* Patients being the object of a saving of justice'}, 'identificationModule': {'nctId': 'NCT01323504', 'acronym': 'Musicthérapy', 'briefTitle': 'Pain and Music Therapy in Patients Suffering Arteritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.', 'orgStudyIdInfo': {'id': 'I09022 / musicthérapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music therapy group', 'description': 'Local care with music', 'interventionNames': ['Other: Music']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Local care without music', 'interventionNames': ['Other: no music']}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'description': 'Patient are listen music during their local care', 'armGroupLabels': ['Music therapy group']}, {'name': 'no music', 'type': 'OTHER', 'description': 'There are no music during the local care', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marc LASKAR, MD', 'role': 'CONTACT', 'phone': '0555056385'}], 'overallOfficials': [{'name': 'Marc LASKAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marc LASKAR', 'oldOrganization': 'CHU de Limoges'}}}}