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

• ClinicalTrials.gov Identifier: NCT03639805
• Recruitment Status: Unknown
• First Posted: August 21, 2018
• Last Update Posted: October 21, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vaso-occlusive Crisis	Other: Music therapy program MUSIC CARE® + standard care; Other: standard care of vaso-occlusive crises	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
• Actual Study Start Date: September 28, 2018
• Estimated Primary Completion Date: April 28, 2020
• Estimated Study Completion Date: April 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: non interventional arm; Standard Of Care	Other: standard care of vaso-occlusive crises; administration of standard care only
Experimental: interventional arm; Standard of Care + music therapy program MUSIC CARE®	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Sylvain LE JEUNE, Dr; 0148955149 ext 33; sylvain.le-jeune@aphp.fr

Contact: Jean-Jacques Mourad, Pr; 0148955141 ext 33; jean-jacques.mourad@aphp.fr

Locations

France

Avicenne University Hospital; Recruiting

Bobigny, France, 93000

Contact: Sylvain LE JEUNE, Dr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Sylvain LE JEUNE, Dr; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03639805
• Other Study ID Numbers: K171205J
• First Posted: August 21, 2018
• Last Update Posted: October 21, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn