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NCT03353584 · ClinicalTrials.gov registry record · NA

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

A NA study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
NA
Development phase
76
Enrollment target
2
Study locations

NCT03353584 is a NA study of Sickle Cell Disease and Vaso-occlusive Crisis that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 76 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT03353584, a NA study of Sickle Cell Disease and Vaso-occlusive Crisis, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

RECRUITING
Registry status
NA
Development phase
76 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • OTHER Virtual Reality Therapy

Study Locations (2)

Tennessee

  • Methodist Comprehensive Sickle Cell Center - Memphis
  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2018-02-05
Est. Completion 2026-11
Phase NA

What the Registry Record Tells You About NCT03353584

The ClinicalTrials.gov registry entry for NCT03353584 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (74% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Virtual Reality Therapy is the first listed.

NCT03353584 reports 2 study locations spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT03353584 about?

NCT03353584 is a clinical study titled "Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease". 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 pai...

What is the current status of trial NCT03353584?

This trial is currently recruiting. It is a NA study. The enrollment target is 76 participants. The study started on 2018-02-05. Estimated completion is 2026-11.

What conditions does trial NCT03353584 study?

This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis.

What interventions are being tested in trial NCT03353584?

The interventions under investigation include: Virtual Reality Therapy (OTHER).

Who is sponsoring clinical trial NCT03353584?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03353584 being conducted?

This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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