Status:
COMPLETED
Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This project will evaluate AppliedVR's EaseVRx - a multi-modal, skills-based, 8-week, virtual reality, home intervention - in an exploratory randomized controlled trial for self-management of chronic ...
Detailed Description
Chronic pain in sickle cell disease (SCD) is a major health problem. Because of the high pain burden associated with SCD and the existing health disparities in comprehensive pain management, non-pharm...
Eligibility Criteria
Inclusion
- Black adults,
- ages 18-50 years;
- diagnosis of SCD (Sickle cell disease);
- chronic non vaso-occlusive pain experienced \> 3 days per week on average for \> 6 months;
- ability to wear a VR (Virtual reality) head-mounted display and move head in cervical rotation, extension, and flexion; sufficient fine motor control to operate VR equipment such as a controller; and ability to read, write, and understand English.
Exclusion
- 1\. Conditions: Co-morbidities that may influence pain perception; diagnosis of epilepsy or susceptibility to seizures, migraines, or other neurological disorders that may prevent VR use, and/or other medical conditions due to which individuals are predisposed to nausea and dizziness; susceptibility to claustrophobia, motion sickness or cybersickness (digital motion sickness); history of blackouts; hypersensitivity to flashing lights or motion; lack of stereoscopic vision; severe visual or hearing impairment; inability to operate VR equipment (such as inability to turn head or use hands to operate external controller); and/or injury to the eyes, face, head, or neck that prevents comfortable VR use.
- 2\. Other exclusions: Medical instability as determined by healthcare providers at the study site; significant motor impairment; surgery within the last three months; planning to start a new pain management strategy (such as medication, physiotherapy, acupuncture, or cognitive behavioral therapy) in the next three months; history of major psychiatric disorder (such as schizophrenia or bipolar disorder) not controlled with medication or behavioral factors that would interfere with study procedures; alcohol or substance dependence, heart conditions, or the presence of implanted medical devices (such as cardiac pacemakers) as noted in the electronic health record; cognitive or developmental disabilities; active suicidal ideation; inability to read, write, or understand English; pregnancy; and/or plans for vacation in the next three months.
- This study will not include any of these special populations:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04906707
Start Date
October 27 2021
End Date
March 5 2024
Last Update
April 20 2025
Active Locations (1)
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1
Grady Memorial Hospital - Outpatient Sickle Cell Clinic
Atlanta, Georgia, United States, 30303