Sickle Cell Disease, Vaso-occlusive Crisis
Conditions
Keywords
Virtual reality, Vaso occlusive seizure, Sickle Cell Disease, Emergency Room, Pain
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.
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.
Interventions
DEVICEVirtual Reality
Use of virtual reality in the management of sickle cell patients with VOS
OTHERUsual Care
Usual management of sickle cell patients with VOS
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of morphine | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of implementing the scheme | 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. |
| Tolerance | up to 48 hours | Side effects such as headache, nausea, eye pain or dizziness |
| Acceptability | up to 48 hours | Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction |
| Pain Efficiency | up to 48 hours | Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality |
Countries
France
Outcome results
None listed