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

Primary Purpose

Vaso-occlusive Crisis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music therapy program MUSIC CARE® + standard care
standard care of vaso-occlusive crises
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaso-occlusive Crisis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Avicenne University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

non interventional arm

interventional arm

Arm Description

Standard Of Care

Standard of Care + music therapy program MUSIC CARE®

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2018
Last Updated
October 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03639805
Brief Title
Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis
Acronym
MUSICODREP
Official Title
Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
April 28, 2020 (Anticipated)
Study Completion Date
April 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaso-occlusive Crisis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non interventional arm
Arm Type
Active Comparator
Arm Description
Standard Of Care
Arm Title
interventional arm
Arm Type
Experimental
Arm Description
Standard of Care + music therapy program MUSIC CARE®
Intervention Type
Other
Intervention Name(s)
Music therapy program MUSIC CARE® + standard care
Intervention Description
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
Intervention Name(s)
standard care of vaso-occlusive crises
Intervention Description
administration of standard care only
Primary Outcome Measure Information:
Title
Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises
Description
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.
Time Frame
End of the third day of hospitalization for severe vaso-occlusive crises

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain LE JEUNE, Dr
Phone
0148955149
Ext
33
Email
sylvain.le-jeune@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Mourad, Pr
Phone
0148955141
Ext
33
Email
jean-jacques.mourad@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain LE JEUNE, Dr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avicenne University Hospital
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain LE JEUNE, Dr

12. IPD Sharing Statement

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Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

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