About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Therapy
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.