Actively Recruiting

Phase Not Applicable
Age: 6Years - 25Years
All Genders
NCT03353584

Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease

Led by St. Jude Children's Research Hospital · Updated on 2025-09-18

76

Participants Needed

2

Research Sites

455 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only 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 by intravenous (IV) or oral route. 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 (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention. 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 (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.

CONDITIONS

Official Title

Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease

Who Can Participate

Age: 6Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must have sickle cell disease (any genotype), documented in the St. Jude medical record.
  • Participant must be seeking care for acute VOC pain at St. Jude Children's Research Hospital.
  • Participant age must be �3E�3D 6 years and �3C�3D 25 years.
  • English speaking
Not Eligible

You will not qualify if you...

  • Prior randomization in this study.
  • Patients are currently enrolled on another pain management interventional trial for the presenting pain crisis.
  • Mild pain (score <4), or pain for which treatment with opioid is not indicated.
  • Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration.
  • Developmental or psychiatric disorders like autism, claustrophobia or other disabilities like vision and hearing defects etc. that preclude the use of a head mounted device.
  • Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Methodist Comprehensive Sickle Cell Center

Memphis, Tennessee, United States, 38104

Completed

2

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

M

Michael Frett, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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