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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease; Vaso-occlusive Crisis
• Intervention / Treatment: Device: Virtual Reality; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • HOPITAL TENON Service des urgences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: INTERVENTION; Use of virtual reality in the management of sickle cell patients with VOS	Device: Virtual Reality; Use of virtual reality in the management of sickle cell patients with VOS
OTHER: NO INTERVENTION	Other: Usual Care; Usual management of sickle cell patients with VOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hélène GOULET, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2021
• Primary Completion (ACTUAL): September 2, 2021
• Study Completion (ACTUAL): September 2, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (ACTUAL): February 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Sickle Cell Disease; Virtual reality; Emergency Room; Vaso occlusive seizure
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Emergencies; Seizures; Anemia, Sickle Cell
• Other Study ID Numbers: APHP190729; IDRCB2020-A00599-30 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No