Clinical trial NCT04756375: Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaso-occlusive Crisis
Sickle Cell Disease
Keywords: Virtual reality
Vaso occlusive seizure
Sickle Cell Disease
Emergency Room
Pain
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total dose of morphine
timeFrame: up to 48 hours
Secondary outcomes:
measure: Feasibility of implementing the scheme
timeFrame: up to 48 hours
measure: Tolerance
timeFrame: up to 48 hours
measure: Acceptability
timeFrame: up to 48 hours
measure: Pain Efficiency
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: HOPITAL TENON Service des urgences
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hélène GOULET, MD
role: PRINCIPAL_INVESTIGATOR
References: