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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

NCT ID: NCT04756375

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2021-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaso-occlusive Crisis Sickle Cell Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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INTERVENTION

Use of virtual reality in the management of sickle cell patients with VOS

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

Use of virtual reality in the management of sickle cell patients with VOS

NO INTERVENTION

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual management of sickle cell patients with VOS

Interventions

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Virtual Reality

Use of virtual reality in the management of sickle cell patients with VOS

Intervention Type DEVICE

Usual Care

Usual management of sickle cell patients with VOS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène GOULET, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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HOPITAL TENON Service des urgences

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB2020-A00599-30

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190729

Identifier Type: -

Identifier Source: org_study_id