Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756375
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2021-02-15
Brief Title:
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReVCVO
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB2020-A00599-30 | OTHER | ANSM | None |