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

Sickle Cell Disease Clinical Trial

— ReVCVO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756375
• Other study ID #: APHP190729
• Secondary ID: IDRCB2020-A00599
• Status: Completed
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: September 2, 2021

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Emergencies
• Seizures
• Sickle Cell Disease
• Vaso-occlusive Crisis

Intervention

Device:
• Virtual Reality
Use of virtual reality in the management of sickle cell patients with VOS

Other:
• Usual Care
Usual management of sickle cell patients with VOS

Locations

Country	Name	City	State
France	HOPITAL TENON Service des urgences	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tolerance	Side effects such as headache, nausea, eye pain or dizziness	up to 48 hours
Secondary	Acceptability	Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction	up to 48 hours
Secondary	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