Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis
MUSICODREP
Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2020
CompletedOctober 21, 2019
October 1, 2019
1.6 years
August 17, 2018
October 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
non interventional arm
ACTIVE COMPARATORStandard Of Care
interventional arm
EXPERIMENTALStandard of Care + music therapy program MUSIC CARE®
Interventions
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.
administration of standard care only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- other hemoglobinopathy
- pregnancy or post-scriptum (40 days after labor)
- antecedent of Reflex Epilepsies
- major hypoacusia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Avicenne University Hospital
Bobigny, 93000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvain LE JEUNE, Dr
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
September 28, 2018
Primary Completion
April 28, 2020
Study Completion
April 28, 2020
Last Updated
October 21, 2019
Record last verified: 2019-10