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

NCT04756375 | Completed

• 2 other identifiers: APHP190729IDRCB2020-A00599-30
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaso-occlusive Crisis; Sickle Cell Disease

Keywords

Virtual reality; Vaso occlusive seizure; Sickle Cell Disease; Emergency Room; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Feasibility of implementing the scheme

  up to 48 hours

• Tolerance

  up to 48 hours

• Acceptability

  up to 48 hours

• Pain Efficiency

  up to 48 hours

Study Arms (2)

INTERVENTION

EXPERIMENTAL

Use of virtual reality in the management of sickle cell patients with VOS

Device: Virtual Reality

NO INTERVENTION

OTHER

Other: Usual Care

Interventions

Virtual Reality DEVICE

Use of virtual reality in the management of sickle cell patients with VOS

INTERVENTION

Usual Care OTHER

Usual management of sickle cell patients with VOS

NO INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• sickle cell patient consulting in the emergency room for VOS
• Signature free and informed consent

You may not qualify if:

• Emergency room consultation more than 12 times in the previous year
• History of epilepsy
• A visually impaired or hard of hearing patient
• Pregnant patient

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

HOPITAL TENON Service des urgences

Paris, 75020, France

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises; Anemia, Sickle Cell; Emergencies; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hélène GOULET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: March 4, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

FR (1)