PMVOCVR: Virtual Reality Therapy for Vaso-Occlusive Crisis in Patients with Sickle Cell Disease

Brief Summary

This clinical trial will evaluate the efficacy of virtual reality (VR) technology when added to standard pain management for patients with sickle cell disease experiencing acute pain crisis in the ambulatory care setting.

Patients will be randomized to receive either standard management 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. 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 technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease

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 technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completing VR during an acute vaso-occlusive crisis in patients with sickle cell disease

Eligibility Criteria

Inclusion criteria include:

• Between 6 and 25 years old
• Diagnosed with sickle cell disease
• Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
• Speaks English

Exclusion Criteria include:

• Currently enrolled on another pain management interventional trial for the presenting pain crisis
• Prior randomization in this study
• Mild pain (score < 4) or pain for which opioid is not indicated
• Pain in combination with other clinical symptoms that require additional interventions
• Developmental or psychiatric disorders that preclude use of a head-mounted device

Study Sites

St. Jude Children’s Research Hospital, Memphis, Tennessee

About this study

Sickle cell disease is a painful group of blood disorders that prevent normal blood flow in the body. Patients with sickle cell disease take pain medicines to treat acute and chronic pain that occurs with their disease. Some patients get complete relief from routine pain medicines. Other patients need to take medicine longer or have more doses of medicine before the pain goes away completely.

Long-term use of pain medicines is associated with a risk for addiction or tolerance in which drugs no longer reduce pain. To reduce these risks, doctors have tried other methods to treat sickle cell disease pain. Virtual reality therapy is an option that provides a computer-generated, relaxing environment for patients. It works by distracting the patient’s attention from the pain. In this study, doctors want to see if VR therapy reduces pain in sickle cell patients experiencing an acute pain crisis.

Purpose of this clinical trial

The main goal of this clinical trial is to find out how well virtual reality therapy lessens acute pain in sickle cell patients. Researchers also want to see if patients use less pain medicine when they are treated with virtual reality therapy.

Eligibility overview

• Between 6 and 25 years old
• Diagnosed with sickle cell disease
• Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
• Speaks English