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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB2020-A00599-30 | Other Identifier | ANSM |
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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.
It will be a Before-after study: this study will be conducted in 2 phases in the emergency department
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION | Experimental | Use of virtual reality in the management of sickle cell patients with VOS |
|
| NO INTERVENTION | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Use of virtual reality in the management of sickle cell patients with VOS |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène GOULET, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPITAL TENON Service des urgences | Paris | 75020 | France |
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| Usual Care | Other | Usual management of sickle cell patients with VOS |
|
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 |
| ID | Term |
|---|---|
| D000098644 | Vaso-Occlusive Crises |
| D000755 | Anemia, Sickle Cell |
| D004630 | Emergencies |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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