Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

NCT ID: NCT03639805

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2020-04-28

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.

Conditions

Vaso-occlusive Crisis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non interventional arm

Standard Of Care

Group Type: ACTIVE_COMPARATOR

standard care of vaso-occlusive crises

Intervention Type: OTHER

administration of standard care only

interventional arm

Standard of Care + music therapy program MUSIC CARE®

Group Type: EXPERIMENTAL

Music therapy program MUSIC CARE® + standard care

Intervention Type: 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.

Interventions

Music 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.

Intervention Type: OTHER

standard care of vaso-occlusive crises

administration of standard care only

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain LE JEUNE, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Avicenne University Hospital

Bobigny, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sylvain LE JEUNE, Dr

Role: CONTACT

sylvain.le-jeune@aphp.fr

0148955149 ext. 33

Jean-Jacques Mourad, Pr

Role: CONTACT

jean-jacques.mourad@aphp.fr

0148955141 ext. 33

Facility Contacts

Sylvain LE JEUNE, Dr

Role: primary

Other Identifiers

K171205J

Identifier Type: -

Identifier Source: org_study_id