N/A
Completed N=44
Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease
Source: ClinicalTrials.gov NCT04906707 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Pain Rating Using Numerical Pain Rating Scale (NPRS) — 3.79; 3.17; 2.37; 2.63 score on a scale
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 pain among Black, young adults (ages 18-50) with sickle cell disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Rating Using Numerical Pain Rating Scale (NPRS) |
3.79; 3.17; 2.37; 2.63 | — |
| PRIMARY Pain Intensity Subscale of the Chronic Pain Grade Questionnaire |
66.84; 63.07; 60.28; 54.06; 56.33; 48.84 | — |
| PRIMARY Participant Engagement: Minutes of Program Use Per Day |
170.5; 128.5; 243.0; 163.25 | — |
| PRIMARY Participant Engagement: Duration in Days |
1.38; 2.75; 1.63; 2.13 | — |
| PRIMARY Participant Engagement: Features Utilized |
6; 11 | — |
| PRIMARY Participant Engagement: Completion Rates |
2.38 | — |
| PRIMARY Study Retention: Surveys |
19; 25; 12; 23; 10; 23 | — |
| PRIMARY Study Retention: Daily Diaries |
28; 32 | — |
| PRIMARY Participant Satisfaction |
4.0; 4.0; 4.0; 4.0; 4.0; 4.0 | — |
| PRIMARY Frequency of Highest Satisfaction Scores |
7; 14; 6; 13; 6; 12 | — |
| PRIMARY Safety: Number of Adverse Events |
2; 0; 0 | — |
| SECONDARY Chronic Pain Acceptance Score |
24.00; 21.40; 26.45; 23.43; 28.20; 23.65 | — |
| SECONDARY Chronic Pain Self-Efficacy |
154.68; 155.92; 155.82; 151.52; 166.40; 148.13 | — |
| SECONDARY Social Support |
111.95; 123.48; 116.55; 129.48; 115.50; 121.52 | — |
| SECONDARY Pain Catastrophizing Score |
22.74; 25.48; 18.82; 21.91; 14.30; 19.26 | — |
| SECONDARY BRIEF Health Literacy Score |
19.05; 18.24; 19.00; 17.65; 18.60; 17.04 | — |
| SECONDARY Executive Function |
78.53; 98.12; 76.27; 83.00; 79.00; 92.43 | — |
| SECONDARY Anxiety Levels |
53.19; 57.38; 52.65; 56.74; 47.72; 54.65 | — |
| SECONDARY Depression Levels |
48.96; 55.60; 48.59; 53.50; 45.99; 52.94 | — |
| SECONDARY Sleep Impact Short Form Score |
49.03; 49.92; 49.75; 50.65; 52.91; 51.64 | — |
| SECONDARY Functional Activities of Daily Living |
49.65; 47.81; 51.77; 47.30; 51.54; 48.06 | — |
| SECONDARY Chronic Pain Disability Score |
56.14; 54.67; 48.06; 51.01; 39.33; 44.20 | — |
| SECONDARY Average Healthcare Utilization |
2.5; 2.0 | — |
| SECONDARY Number of Analgesics |
4.88; 3.80; 4.86; 4.69 | — |
| SECONDARY Quality of Life: Frequency of Sickle Cell Pain Episodes |
51.85; 47.65; 50.08; 46.27; 48.74; 45.93 | — |
| SECONDARY Quality of Life: Severity of Sickle Cell Pain Episodes |
52.79; 45.84; 49.32; 46.19; 50.42; 44.87 | — |
| SECONDARY Quality of Life: Emotional Impact |
51.70; 49.21; 54.56; 52.57; 55.13; 51.53 | — |
| SECONDARY Quality of Life: Social Functioning |
49.48; 51.43; 56.04; 50.33; 53.50; 51.92 | — |
| SECONDARY Quality of Life: Stiffness Impact |
47.73; 45.78; 52.20; 46.58; 52.02; 47.06 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT04906707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.