PMVOCVR: Virtual Reality Therapy for Vaso-Occlusive Crisis in Patients with Sickle Cell Disease

Virtual Reality Pain Management of Vaso-Occlusive Crisis in Children and Young Adults with Sickle Cell Disease

Category:

Sickle Cell Disease

Diseases Treated:

Sickle cell disease

Eligibility Overview:

This is a non-therapeutic clinical trial that is open only to patients at St. Jude or Methodist Healthcare.

  • Between 6 and 25 years old
  • Diagnosed with sickle cell disease
  • Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
  • Speaks English
  1. Brief Summary

    This clinical trial will evaluate the efficacy of virtual reality (VR) technology when added to standard pain management for patients with sickle cell disease experiencing acute pain crisis in the ambulatory care setting.

    Patients will be randomized to receive either standard management or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines. Pain scores and opioid requirement will be measured and compared across treatment arms, along with the outcomes of discharge from clinic versus admission to the inpatient unit.

    Primary Objective

    • To assess the efficacy of virtual reality technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease

    Secondary Objectives

    • To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms
    • To assess the efficacy of virtual reality technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completing VR during an acute vaso-occlusive crisis in patients with sickle cell disease

    Eligibility Criteria

    Inclusion criteria include:

    • Between 6 and 25 years old
    • Diagnosed with sickle cell disease
    • Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
    • Speaks English

    Exclusion Criteria include:

    • Currently enrolled on another pain management interventional trial for the presenting pain crisis
    • Prior randomization in this study
    • Mild pain (score < 4) or pain for which opioid is not indicated
    • Pain in combination with other clinical symptoms that require additional interventions
    • Developmental or psychiatric disorders that preclude use of a head-mounted device

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. About this study

    Sickle cell disease is a painful group of blood disorders that prevent normal blood flow in the body. Patients with sickle cell disease take pain medicines to treat acute and chronic pain that occurs with their disease. Some patients get complete relief from routine pain medicines. Other patients need to take medicine longer or have more doses of medicine before the pain goes away completely.

    Long-term use of pain medicines is associated with a risk for addiction or tolerance in which drugs no longer reduce pain. To reduce these risks, doctors have tried other methods to treat sickle cell disease pain. Virtual reality therapy is an option that provides a computer-generated, relaxing environment for patients. It works by distracting the patient’s attention from the pain. In this study, doctors want to see if VR therapy reduces pain in sickle cell patients experiencing an acute pain crisis.

    Purpose of this clinical trial

    The main goal of this clinical trial is to find out how well virtual reality therapy lessens acute pain in sickle cell patients. Researchers also want to see if patients use less pain medicine when they are treated with virtual reality therapy.

    Eligibility overview

    • Between 6 and 25 years old
    • Diagnosed with sickle cell disease
    • Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
    • Speaks English
  3. PMVOCVR Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT03353584
    Trial Start Date January 2018
    Estimated Enrollment 60
    Study Type Interventional
    Study Phase Phase 2
    Conditions Sickle cell disease
    Ages Between 6 and 25 years old
    Principal investigator Latika Puri, MD
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss REHASH St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Latika Puri, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.