Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT03639805
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], 'ancestors': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises', 'timeFrame': 'End of the third day of hospitalization for severe vaso-occlusive crises', 'description': 'The total morphine consumption will be calculated for the first 3 days of hospitalization by a doctor, and a mean daily consumption will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaso-occlusive Crisis']}, 'descriptionModule': {'briefSummary': 'Treatment of painful vaso-occlusive crises, the most common manifestation of sickle cell disease, is notoriously limited. vaso-occlusive crises pain is multifactorial with a psychological component. The hypothesis is that the music therapy program MUSIC CARE® can help alleviate severe vaso-occlusive crises pain in synergy with traditional treatment in sickle cell disease patients. The main objective of this prospective, randomized, open label study is to test the effect of the music therapy program MUSIC CARE® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises.', 'detailedDescription': 'Sickle cell disease, the most frequent monogenic disease in France and in the world, is induced by a mutation in the β-globin chain of hemoglobin with production of hemoglobin S. The course of the disease is characterized by very painful, for which treatment is notoriously limited. vaso-occlusive crises pain is multifactorial with biological and psychological components. A few studies suggest a beneficial effect of relaxation techniques in the management of Sickle cell disease pain. MUSIC CARE® is a novative music therapy program which proved efficient in different models of acute or chronic pain. the hypothesis is that this program can help alleviate severe pain in synergy with traditional treatment in SS Sickle cell disease patients, via a dual biological and psychological effect. The main objective of this prospective, randomized, open label study is to test the effect of the music therapy program MUSIC CARE® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises in adult SS Sickle cell disease patients. Secondary outcomes will include mean daily Visual Analogic Scale during the first 3 days of hospitalization for severe vaso-occlusive crises, acute complications of vaso-occlusive crises, duration of severe vaso-occlusive crises and of hospitalization, Hospital Anxiety and Depression Scale.\n\n20 patients will be included in each group for this pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years\n* patients with homozygous Sickle Cell Disease (HbSS,or HbSß0) confirmed by laboratory center\n* hospitalized for severe vaso-occlusive crisis\n* Visual Analogic Scale≥6 at entry\n* able to speak and write French\n* Patient in physical and clinical capacity of consent (signature of the informed consent of the patient or in the presence of a third party)\n* affiliated to a social insurance; not subject to a legal protection\n\nExclusion Criteria:\n\n* other hemoglobinopathy\n* pregnancy or post-scriptum (40 days after labor)\n* antecedent of Reflex Epilepsies\n* major hypoacusia\n* Patients already engaged in a therapeutic protocol or in the period of exclusion after a previous interventional research.'}, 'identificationModule': {'nctId': 'NCT03639805', 'acronym': 'MUSICODREP', 'briefTitle': 'Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study', 'orgStudyIdInfo': {'id': 'K171205J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non interventional arm', 'description': 'Standard Of Care', 'interventionNames': ['Other: standard care of vaso-occlusive crises']}, {'type': 'EXPERIMENTAL', 'label': 'interventional arm', 'description': 'Standard of Care + music therapy program MUSIC CARE®', 'interventionNames': ['Other: Music therapy program MUSIC CARE® + standard care']}], 'interventions': [{'name': 'Music therapy program MUSIC CARE® + standard care', 'type': 'OTHER', 'description': 'Administration of a specific music therapy program (U method) delivered through headphones from an iPad, under the direction of trained nurses. The program will be proposed 3 times a day and will last 20 minutes at each session.', 'armGroupLabels': ['interventional arm']}, {'name': 'standard care of vaso-occlusive crises', 'type': 'OTHER', 'description': 'administration of standard care only', 'armGroupLabels': ['non interventional arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain LE JEUNE, Dr', 'role': 'CONTACT'}], 'facility': 'Avicenne University Hospital', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'centralContacts': [{'name': 'Sylvain LE JEUNE, Dr', 'role': 'CONTACT', 'email': 'sylvain.le-jeune@aphp.fr', 'phone': '0148955149', 'phoneExt': '33'}, {'name': 'Jean-Jacques Mourad, Pr', 'role': 'CONTACT', 'email': 'jean-jacques.mourad@aphp.fr', 'phone': '0148955141', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Sylvain LE JEUNE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}