Vaso-occlusive Crisis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMusic therapy program MUSIC CARE® + standard care
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.
OTHERstandard care of vaso-occlusive crises
administration of standard care only
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * patients with homozygous Sickle Cell Disease (HbSS,or HbSß0) confirmed by laboratory center * hospitalized for severe vaso-occlusive crisis * Visual Analogic Scale≥6 at entry * able to speak and write French * Patient in physical and clinical capacity of consent (signature of the informed consent of the patient or in the presence of a third party) * affiliated to a social insurance; not subject to a legal protection
Exclusion criteria
* other hemoglobinopathy * pregnancy or post-scriptum (40 days after labor) * antecedent of Reflex Epilepsies * major hypoacusia * Patients already engaged in a therapeutic protocol or in the period of exclusion after a previous interventional research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises | End of the third day 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. |
Countries
France
Contacts
Primary ContactSylvain LE JEUNE, Dr
Backup ContactJean-Jacques Mourad, Pr
Outcome results
None listed