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

Study Overview
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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.

Official Title
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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

Conditions
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Vaso-occlusive Crisis, Sickle Cell Disease

Intervention / Treatment
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* Device: Virtual Reality
* Other: Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERVENTION<br>Use of virtual reality in the management of sickle cell patients with VOS | Device: Virtual Reality<br>* Use of virtual reality in the management of sickle cell patients with VOS<br>|
| Other: NO INTERVENTION<br> | Other: Usual Care<br>* Usual management of sickle cell patients with VOS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine | 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 | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of implementing the scheme | 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. | up to 48 hours | 
| Tolerance | Side effects such as headache, nausea, eye pain or dizziness | up to 48 hours | 
| Acceptability | Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction | up to 48 hours | 
| Pain Efficiency | Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Vaso occlusive seizure, Sickle Cell Disease, Emergency Room, Pain