MUSICODREP: Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT03639805

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Sep 28, 2018

Anticipated Primary Completion Date :

Apr 28, 2020

Anticipated Study Completion Date :

Apr 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.

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

Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Avicenne University Hospital	Bobigny		France	93000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT03639805

Other Study ID Numbers:

K171205J

First Posted:

Aug 21, 2018

Last Update Posted:

Oct 21, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of Oct 21, 2019