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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Vaso-occlusive Crisis; Sickle Cell Disease

Treatments: Device: Virtual Reality; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04756375

APHP190729

IDRCB2020-A00599-30 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

INTERVENTION

Experimental group

Description:

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

Treatment:

Device: Virtual Reality

NO INTERVENTION

Other group

Treatment:

Other: Usual Care