Vaso-occlusive Crisis Clinical Trial
Official title:
Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
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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