Sickle Cell Disease Clinical Trial
Official title:
Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
NCT number | NCT03353584 |
Other study ID # | PMVOCVR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2018 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Methodist Comprehensive Sickle Cell Center | Memphis | Tennessee |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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