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Completed

NCT Number: NCT04756375

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

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.

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Key information

Conditions

Vaso-occlusive Crisis Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Emergencies Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Sickle Cell Disease Signs and Symptoms Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOPITAL TENON Service des urgences

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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

Usual Care

Other

Usual management of sickle cell patients with VOS

Primary outcomes

  1. Total dose of morphine

    Time frame: up to 48 hours

    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

Secondary outcomes

  1. Feasibility of implementing the scheme

    Time frame: up to 48 hours

    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.

  2. Tolerance

    Time frame: up to 48 hours

    Side effects such as headache, nausea, eye pain or dizziness

  3. Acceptability

    Time frame: up to 48 hours

    Patient's willingness to use VR again at future VOS Evaluation of patient satisfaction

  4. Pain Efficiency

    Time frame: up to 48 hours

    Evaluation of AVS before and after the virtual reality session Numbers of painful areas before and after virtual reality

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ReVCVO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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