| Doralina Anghelescu, MD | |
| 866-278-5833 | |
| [email protected] |
2 United States sites
6 to 25 Years
N/A
Interventional
All
Other
Unknown
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.
– 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 or the Methodist Health system.
– Participant age must be ≥ 6 years and ≤ 25 years.
– English speaking
– 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.