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Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room (ReVCVO)

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ClinicalTrials.gov Identifier: NCT04756375
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel.

With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data.

Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.


Condition or disease Intervention/treatment Phase
Vaso-occlusive Crisis Sickle Cell Disease Device: Virtual Reality Other: Usual Care Not Applicable

Detailed Description:

It will be a Before-after study: this study will be conducted in 2 phases in the emergency department

  • a period of usual management of sickle cell patients with VOS
  • then a phase during which the device will be used. Each phase will last 3 months; the duration of the periods may be shorter if recruitment targets are met. Patients will be included consecutively.

The main objective of the study is to measure the impact of virtual reality on the total dose of morphine administered to the emergency room in the treatment of vaso-occlusive seizures after initial morphine titration.

The primary endpoint is the total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA (patient-controlled analgesia) and secondary titrations in the event of a recurrence of painful spikes with analog verbal scale (AVS) >7.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: INTERVENTION
Use of virtual reality in the management of sickle cell patients with VOS
Device: Virtual Reality
Use of virtual reality in the management of sickle cell patients with VOS

NO INTERVENTION Other: Usual Care
Usual management of sickle cell patients with VOS




Primary Outcome Measures :
  1. Total dose of morphine [ Time Frame: up to 48 hours ]
    Total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA and secondary titrations in case of recurrence of painful peak with AVS>7


Secondary Outcome Measures :
  1. Feasibility of implementing the scheme [ Time Frame: up to 48 hours ]
    Number of patents included in the protocol vs. number of potentially eligible patients For patients included during the VR period: the number of VR sessions performed, and the duration of these sessions.

  2. Tolerance [ Time Frame: up to 48 hours ]
    Side effects such as headache, nausea, eye pain or dizziness

  3. Acceptability [ Time Frame: up to 48 hours ]
    Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction

  4. Pain Efficiency [ Time Frame: up to 48 hours ]
    Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • sickle cell patient consulting in the emergency room for VOS
  • Signature free and informed consent

Exclusion Criteria:

  • Consultation in the ER for the same reason in the 14 days prior to inclusion (same episode)
  • Emergency room consultation more than 12 times in the previous year
  • Nausea and vomiting at the time of inclusion
  • History of epilepsy
  • A visually impaired or hard of hearing patient
  • Pregnant patient
  • Previous inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04756375


Contacts
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Contact: Hélène GOULET, MD 06 62 70 91 75 helene.goulet@aphp.fr
Contact: Evelyne DUBREUCQ, MD 06 52 09 64 28 evelyne.dubreucq@aphp.fr

Locations
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France
HOPITAL TENON Service des urgences
Paris, France, 75020
Contact: Hélène GOULET, MD    06 62 70 91 75    helene.goulet@aphp.fr   
Contact: Evelyne DUBREUCQ, MD    06 52 09 64 28    evelyne.dubreucq@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Hélène GOULET, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04756375    
Other Study ID Numbers: APHP190729
IDRCB2020-A00599-30 ( Other Identifier: ANSM )
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Virtual reality
Vaso occlusive seizure
Sickle Cell Disease
Emergency Room
Pain
Additional relevant MeSH terms:
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Seizures
Anemia, Sickle Cell
Emergencies
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn