Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

Vaso-occlusive Crisis Clinical Trial

— MUSICODREP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03639805
• Other study ID #: K171205J
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: April 28, 2020

Study information

• Verified date: October 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sylvain LE JEUNE, Dr
• Phone: 0148955149
• Email: sylvain.le-jeune[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 28, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Vaso-occlusive Crisis

Intervention

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.
• standard care of vaso-occlusive crises
administration of standard care only

Locations

Country	Name	City	State
France	Avicenne University Hospital	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily mean morphine consumption during the first 3 days 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.	End of the third day of hospitalization for severe vaso-occlusive crises