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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT03353584
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Virtual Reality Therapy — OTHER
    The VR intervention consists of an interactive audio and visual underwater experience designed to serve as a calming distraction activity. The VR software (Kind VR® Aqua) was developed by KindVR specifically for the purpose of pain distraction in a hospital setting.

Study Details

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.

Key Dates

Start date
Feb 5, 2018
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Standard Care
    Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.
  • Active Comparator: Virtual Reality
    Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age.

Primary Outcome Measure

Change in pain scores [ Time Frame: Baseline and up to 30 minutes after intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Methodist Comprehensive Sickle Cell CenterMemphisTennessee38104-
St. Jude Children's Research HospitalMemphisTennessee38105
Michael Frett, MD
[email protected]
888-226-4343
Michael Frett, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
Methodist Comprehensive Sickle Cell Center· Memphis, TNSt. Jude Children's Research Hospital· Memphis, TN

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