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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.
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.
20 patients will be included in each group for this pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non interventional arm | Active Comparator | Standard Of Care |
|
| interventional arm | Experimental | Standard of Care + music therapy program MUSIC CARE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy program MUSIC CARE® + standard care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises | 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. | End of the third day of hospitalization for severe vaso-occlusive crises |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvain LE JEUNE, Dr | Contact | 0148955149 | 33 | sylvain.le-jeune@aphp.fr |
| Jean-Jacques Mourad, Pr | Contact | 0148955141 | 33 | jean-jacques.mourad@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvain LE JEUNE, Dr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avicenne University Hospital | Recruiting | Bobigny | 93000 | France |
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| ID | Term |
|---|---|
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| standard care of vaso-occlusive crises | Other | administration of standard care only |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |