Vaso-occlusive CrisisMUSICODREPNCT03639805
Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis
A study of Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaso-occlusive Crisis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2018to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Avicenne University Hospital
Bobigny, 93000
Sylvain LE JEUNE, Dr
About this study
Official title: Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
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.
Read the 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.
- Conditions
- Vaso-occlusive Crisis
- Being tested
- Music therapy program MUSIC CARE® + standard care, standard care of vaso-occlusive crises
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy program MUSIC CARE® + standard careOther
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 crisesOther
administration of standard care only
| Study group | Role | What they receive |
|---|---|---|
| non interventional arm | Active comparator | Standard Of Care Receives: Other: standard care of vaso-occlusive crises |
| interventional arm | Experimental | Standard of Care + music therapy program MUSIC CARE® Receives: Other: Music therapy program MUSIC CARE® + standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of the third day of hospitalization for severe vaso-occlusive crises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start28 Sep 2018
- Primary completion28 Apr 2020 (estimated)
- Study completion28 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaso-occlusive CrisisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain LE JEUNE, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639805
- Sponsor's protocol ID
- K171205J
- Acronym
- MUSICODREP
- Status last verified
- Oct 2019
- First submitted
- 17 Aug 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03639805
- Acronym / sponsor ID
- MUSICODREP / K171205J
- Conditions
- Vaso-occlusive Crisis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 28 Apr 2020 (estimated)
- Study completion
- 28 Apr 2020 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non interventional arm | Active comparator | Other: standard care of vaso-occlusive crisesStandard Of Care |
| interventional arm | Experimental | Other: Music therapy program MUSIC CARE® + standard careStandard of Care + music therapy program MUSIC CARE® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy program MUSIC CARE® + standard careAdministration 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. | Other | interventional arm |
| standard care of vaso-occlusive crisesadministration of standard care only | Other | non interventional arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Related trials for Vaso-occlusive Crisis
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Recruiting
Virtual Reality for SCD VOC
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain LE JEUNE, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain LE JEUNE, Dr (0148955149 ext. 33, sylvain.le-jeune@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.