Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis (MUSICODREP)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Vaso-occlusive Crisis

Treatments: Other: standard care of vaso-occlusive crises; Other: Music therapy program MUSIC CARE® + standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03639805

K171205J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

non interventional arm

Active Comparator group

Description:

Standard Of Care

Treatment:

Other: standard care of vaso-occlusive crises

interventional arm

Experimental group

Description:

Standard of Care + music therapy program MUSIC CARE®

Treatment:

Other: Music therapy program MUSIC CARE® + standard care