Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)

About the study

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 pain among Black, young adults (ages 18-50) with sickle cell disease.

Study point of contact

Nadine Matthie, PhD, RN, CNL
404-712-8449
[email protected]

Locations

26 United States sites

Age

18 Years - 50 Years

Phase

Not Applicable

Study type

Interventional

Gender

All

Interventions

Device

Behavioral

participation requirements

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.

participation restrictions

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

Locations

  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]
  • Atlanta, Georgia, United States, Grady Memorial Hospital - Outpatient Sickle Cell Clinic [Recruiting]

MORE INFORMATION

View on ClinicalTrials.gov
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Last updated 2022-12-19