Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
1 other identifier
interventional
76
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedStudy Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
September 18, 2025
September 1, 2025
8.7 years
November 21, 2017
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain scores
The highest pain score based on all scores at different body pain locations is used as the pain score. The changes in pain scores in two arms between baseline and 30 minutes post study intervention will be summarized and compared using Wilcoxon rank sum test at a significance level of 0.1.
Baseline and up to 30 minutes after intervention
Study Arms (2)
Standard Care
NO INTERVENTIONParticipants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.
Virtual Reality
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 ≥ 6 years and ≤ 25 years.
- English speaking
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Methodist Comprehensive Sickle Cell Center
Memphis, Tennessee, 38104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Frett, MD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2017
First Posted
November 27, 2017
Study Start
February 5, 2018
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
September 18, 2025
Record last verified: 2025-09