Sickle Cell DiseaseNCT04906707
Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease
A study testing EaseVRx and Audio-only version of EaseVRx in people with Sickle Cell Disease, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- EaseVRx and Audio-only version of EaseVRx
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Memorial Hospital - Outpatient Sickle Cell Clinic
Atlanta, Georgia, 30303
About this study
Official title: Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)
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.
Read the 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-pharmacological, home-based strategies are urgently needed to help manage chronic pain. In this study, the investigators will use a single-site, 8-week, randomized clinical trial (with follow-up at 12 weeks) to evaluate a home-based, pain self-management program for chronic pain in Black adults with SCD. Study participants will be identified from the group of patients with chronic pain who receive care in the SCD clinic of the Georgia Comprehensive Sickle Cell Center at Grady Memorial Hospital (Grady) in Atlanta, Georgia. Patients may be recommended by the Center's staff or may self-identify in response to study flyers posted in the Center, health facilities or community-based organizations in surrounding areas, or on social media. Recruitment and consent will take place in a private area of the SCD clinic, the research center in the Nell Hodgson Woodruff School of Nursing at Emory University, or remotely if necessary. Consent may also occur remotely if necessary.
After enrollment, in-person study activities will take place in the SCD clinic or the research center while remote study activities will take place in participants' homes on their own time. Participants will complete questionnaires and a pain diary, use the pain management program at home (delivered with a virtual reality device or audio only on SoundCloud), and complete a qualitative interview or focus group session. Compensation will be provided after completion of each of these study activities. During the study, subjects will continue their standard pain management routine, including any pain medications, as prescribed by their healthcare provider.
This research will advance both scientific knowledge and human health by focusing on addressing unmet needs for an underserved population. This study is the first randomized clinical trial that investigates a virtual reality, home-based pain self-management program for chronic pain in adults with SCD. Therefore, this study represents the first essential step in developing a culturally-tailored, non-pharmacological, home-based, chronic pain self-management intervention specifically for Black adults with SCD that can be used along with standard SCD care.
- Conditions
- Sickle Cell Disease
- Being tested
- EaseVRx, Audio-only version of EaseVRx
- Keywords
- Pain management, Virtual Reality Device
- Medical subject headings
- Anemia, Sickle Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EaseVRxDevice
EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.
Audio-only version of EaseVRxBehavioural
Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
| Study group | Role | What they receive |
|---|---|---|
| EaseVRx Group | Experimental | Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. Receives: Device: EaseVRx |
| Active control Group | Active comparator | Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Receives: Behavioral: Audio-only version of EaseVRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Using Numerical Pain Rating Scale (NPRS)
For daily measures, self-reported pain ratings will be assessed with the Numerical Pain Rating Scale (NPRS). On the NPRS, pain intensity levels range from 0 to 10 (0 = no pain and 10 = worst pain). Lower pain ratings correlate with better outcome.
Daily Pain Diary responses were intermittent and can only be aggregated during time period 1 (days 1-28) and time period 2 (days 29-56). Diaries were not administered at day 0.
Measured: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire
For baseline and monthly measurements, self-reported pain ratings were assessed with the Pain Intensity subscale of the Chronic Pain Grade Questionnaire. On the Chronic Pain Grade Questionnaire, pain intensity levels range from 0-100. Lower pain ratings correlate with better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Participant Engagement: Minutes of Program Use Per Day
Minutes of daily program use may range from 2 minutes to 48 minutes or more. The investigator hypothesizes that higher usage will correlate with a better outcome.
Because of intermittent usage patterns, self-reported program use was aggregated during time period 1 (days 1-28) and time period 2 (days 29-56).
Measured: up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
Participant Engagement: Duration in Days
Throughout the 8-week treatment period, device usage duration may range from 0 to 7 days each week. The investigator hypothesizes that higher usage will correlate with a better outcome.
Measured: Baseline, daily during treatment (4 weeks or time period 1, day 1-28), daily during treatment (8 weeks or time period 2, days 29-56)
Participant Engagement: Features Utilized
Assessed by the number of features utilized when using the VRdevice. The number of features utilized may be 1 or 2 . The investigator hypothesizes that use of a higher number of features will correlate with a better outcome.
Measured: Daily during treatment (8 weeks)
Participant Engagement: Completion Rates
Assessed by completion rates: the number of modules completed weekly. Rates may range from 0 to 7 modules completed each week. The investigator hypothesizes that completion of a higher number of modules weekly will correlate with a better outcome.
Measured: Daily average during treatment (up to 8 weeks)
Study Retention: Surveys
Assessed by participant completion of survey measures at repeated timepoints (baseline, week 4, week 8, and week 12). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Measured: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)
Study Retention: Daily Diaries
Assessed by participant completion of daily diaries across 8 weeks of treatment (days 1-56). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Measured: Up to 8 weeks
Participant Satisfaction
Assessed, once at the end of the program, via individual qualitative interviews or focus group sessions. Participants will be asked to evaluate the program by responding to the four items listed below, using a Likert scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree with possible score range 1-4) for the first three items and 1-10 (with 10 being definitely would recommend) for the fourth item.• The VR program was easy to use.• I enjoyed using the VR program.• The content in the VR program helped me cope with my pain.• On a scale of 1-10, how likely are you to recommend the VR program to someone else at this time? The investigator hypothesizes that responses of strongly agree and higher scores will correlate with a better outcome.
Measured: Post-treatment (up to 6 weeks post-treatment)
Frequency of Highest Satisfaction Scores
Assessed once at the end of the program, via individual qualitative interviews or focus group sessions.
Participants choosing the highest score for each of the four items listed will be counted.
Higher number correlates with a better outcome.
Measured: Post-treatment (up to 6 weeks post-treatment)
Safety: Number of Adverse Events
Assessed by monitoring participants for the number of adverse events. Fewer adverse events correlate with a better outcome.
Measured: 4 weeks, 8 weeks, up to 6 weeks post-treatment
Secondary outcomes (18)
Chronic Pain Acceptance Score
Assessed by the Chronic Pain Acceptance Questionnaire (CPAQ-8) which measures acceptance of chronic pain. Items are scored on a scale from 0 to 6 (never true to always true), and higher scores (total possible scores range from 0 to 48) indicate higher levels of acceptance (better outcome).
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Chronic Pain Self-Efficacy
Assessed by using the Chronic Pain Self-Efficacy Scale (CPSES), which measures efficacy expectations for coping with the consequences of chronic pain. Items are scored on a 10-point Likert-type scale from 1 (very uncertain) to 10 (very certain), with a minimum total score of 22 and a maximum total score of 220. Higher scores indicate a better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Social Support
Assessed by using the Social Support Questionnaire (SSQ), which measures perceptions of the desirability, availability, use, and usefulness of social support. Items are scored on a scale from 1 (not at all) to 5 (very much, constantly), with a minimum total score of 32 and a maximum total score of 160. Higher scores indicate a better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)
Pain Catastrophizing Score
Assessed by using the Pain Catastrophizing Scale (PCS-13) which measures thoughts and feelings when pain is experienced. Items are scored on a scale from 0 to 4 (not at all to all the time), and higher scores (scores range from 0 to 52) indicate a higher degree of catastrophizing (worse outcome).
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
BRIEF Health Literacy Score
Assessed by using the BRIEF Health Literacy Screening Tool which measures the amount of help needed in healthcare situations. Items are scored on a scale from 1 to 5 (always to never and not at all to extremely), and higher total scores (scores range from 4 to 20) indicate greater health literacy (better outcome).
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Executive Function
Behavior Rating Inventory of Executive Function (BRIEF-A) which measures adult executive functioning/self-regulation. Items are scored on a scale from 1 to 7 (never a problem to always a problem) and higher total scores (scores range from 34 to 238) indicate more symptoms of executive dysfunction (worse outcome).
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Anxiety Levels
Assessed by using PROMIS Emotional Distress - Anxiety (Anxiety 8a - Adult v1.0), which measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) and the total raw score (minimum total score of 8 and maximum total score of 40) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 37.1 and a maximum total score of 83.1, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Depression Levels
Assessed by using PROMIS Emotional Distress - Depression (Depression 8a - Adult v1.0), which measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) and the total raw score (minimum total score of 8 and maximum total score of 40) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 38.2 and a maximum total score of 81.3, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Sleep Impact Short Form Score
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Sleep Impact Short Form, which measures sleep disturbances. 5 items are assessed using a scale that ranges from 1 (never or always) to 5 (never or always) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 27.9 and a maximum total score of 69.1, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Functional Activities of Daily Living
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Impact Short Form, which measures the effects of sickle cell pain on activities of daily living. 5 items are assessed using a scale that ranges from 1 (always) to 5 (never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 24.8 and a maximum total score of 63.8, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.
Measured: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Chronic Pain Disability Score
Assessed by the Chronic Pain Grade Questionnaire (CPGQ) which classifies individuals into one of four categories according to pain severity or interference. Items are scored on a scale from 0 to 10, with total scores for chronic pain intensity and chronic pain disability ranging from 0 to 100. Higher total scores indicate a higher level of disability that is severely limiting (worse outcome).
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Average Healthcare Utilization
Assessed by healthcare utilization for pain in the previous 12 months as reflected by self-reported number of healthcare visits. The number of healthcare visits may range from 0 to 20 or more. A higher number of visits is correlated with worse outcome.
Measured: Baseline
Number of Analgesics
Assessed by self-reported number of over-the-counter analgesics used per day via the Daily Pain Diary. Results will be reported during time period 1 (days 1-28) and time period 2 (days 29-56). A higher number of pain medications correlates with a worse outcome.
Measured: Time period 1 (days 1-28) and time period 2 (days 29-56)
Quality of Life: Frequency of Sickle Cell Pain Episodes
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episodes Short Form, which measures the frequency and severity of sickle cell pain episodes. 2 items are assessed using a scale that varies across the items, with values ranging from 0-4 or 0-7, and the total raw score (minimum total score of 0 and maximum total score of 11) is rescaled into a standardized T-score. The standardized T-score has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Severity of Sickle Cell Pain Episodes
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episodes Short Form, which measures the frequency and severity of sickle cell pain episodes. 3 items are assessed using a scale that varies across the items, with values ranging from 0-7, 0-5, or 0-10, and the total raw score (minimum total score of 0 and maximum total score of 22) is rescaled into a standardized T-score. The standardized T-score has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Emotional Impact
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Emotional Impact Short Form, which measures the effects of sickle cell on emotional well-being. 5 items are assessed using a scale that ranges from 1 (always or very much) to 5 (never or not at all) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 26.8 and a maximum total score of 65.6, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Social Functioning
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Social Functioning Short Form, which measures the influence of health on social functioning. 5 items are assessed using a scale that ranges from 1 (very much or always) to 5 (not at all or never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 26 and a maximum total score of 69.8, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Stiffness Impact
Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Stiffness Impact Short Form, which measures joint/body stiffness. 5 items are assessed using a scale that ranges from 1 (always) to 5 (never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 24.9 and a maximum total score of 65.4, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.
Measured: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start27 Oct 2021
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Nadine Matthie, Emory University
- Investigators
- Nadine Matthie, PhD, RN, CNL, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906707
- Sponsor's protocol ID
- STUDY00002004
- Other IDs
- 1R21NR019872-01
- Status last verified
- Apr 2025
- First submitted
- 27 May 2021
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: * Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices) * Investigators whose proposed used of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose * For individual participant data meta-analysis
Publications
Matthie N, Higgins M, Jenerette C. Preliminary Benefits of In-Home Virtual Reality for Chronic Pain in Sickle Cell Disease: Pilot Randomized Trial. Biomedicines. 2026 Jun 12;14(6):1334. doi: 10.3390/biomedicines14061334.
PubMed 42351762
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)
- ClinicalTrials.gov ID
- NCT04906707
- Acronym / sponsor ID
- STUDY00002004
- Conditions
- Sickle Cell Disease
- Keywords
- Pain management, Virtual Reality Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-pharmacological, home-based strategies are urgently needed to help manage chronic pain. In this study, the investigators will use a single-site, 8-week, randomized clinical trial (with follow-up at 12 weeks) to evaluate a home-based, pain self-management program for chronic pain in Black adults with SCD. Study participants will be identified from the group of patients with chronic pain who receive care in the SCD clinic of the Georgia Comprehensive Sickle Cell Center at Grady Memorial Hospital (Grady) in Atlanta, Georgia. Patients may be recommended by the Center's staff or may self-identify in response to study flyers posted in the Center, health facilities or community-based organizations in surrounding areas, or on social media. Recruitment and consent will take place in a private area of the SCD clinic, the research center in the Nell Hodgson Woodruff School of Nursing at Emory University, or remotely if necessary. Consent may also occur remotely if necessary.
After enrollment, in-person study activities will take place in the SCD clinic or the research center while remote study activities will take place in participants' homes on their own time. Participants will complete questionnaires and a pain diary, use the pain management program at home (delivered with a virtual reality device or audio only on SoundCloud), and complete a qualitative interview or focus group session. Compensation will be provided after completion of each of these study activities. During the study, subjects will continue their standard pain management routine, including any pain medications, as prescribed by their healthcare provider.
This research will advance both scientific knowledge and human health by focusing on addressing unmet needs for an underserved population. This study is the first randomized clinical trial that investigates a virtual reality, home-based pain self-management program for chronic pain in adults with SCD. Therefore, this study represents the first essential step in developing a culturally-tailored, non-pharmacological, home-based, chronic pain self-management intervention specifically for Black adults with SCD that can be used along with standard SCD care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EaseVRx Group | Experimental | Device: EaseVRxParticipants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. |
| Active control Group | Active comparator | Behavioral: Audio-only version of EaseVRxParticipants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EaseVRxEaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment. | Device | EaseVRx Group |
| Audio-only version of EaseVRxParticipants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. | Behavioural | Active control Group |
Primary outcome
Pain Rating Using Numerical Pain Rating Scale (NPRS)
Time frame: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
For daily measures, self-reported pain ratings will be assessed with the Numerical Pain Rating Scale (NPRS). On the NPRS, pain intensity levels range from 0 to 10 (0 = no pain and 10 = worst pain). Lower pain ratings correlate with better outcome. Daily Pain Diary responses were intermittent and can only be aggregated during time period 1 (days 1-28) and time period 2 (days 29-56). Diaries were not administered at day 0.
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
For baseline and monthly measurements, self-reported pain ratings were assessed with the Pain Intensity subscale of the Chronic Pain Grade Questionnaire. On the Chronic Pain Grade Questionnaire, pain intensity levels range from 0-100. Lower pain ratings correlate with better outcome.
Participant Engagement: Minutes of Program Use Per Day
Time frame: up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
Minutes of daily program use may range from 2 minutes to 48 minutes or more. The investigator hypothesizes that higher usage will correlate with a better outcome. Because of intermittent usage patterns, self-reported program use was aggregated during time period 1 (days 1-28) and time period 2 (days 29-56).
Participant Engagement: Duration in Days
Time frame: Baseline, daily during treatment (4 weeks or time period 1, day 1-28), daily during treatment (8 weeks or time period 2, days 29-56)
Throughout the 8-week treatment period, device usage duration may range from 0 to 7 days each week. The investigator hypothesizes that higher usage will correlate with a better outcome.
Participant Engagement: Features Utilized
Time frame: Daily during treatment (8 weeks)
Assessed by the number of features utilized when using the VRdevice. The number of features utilized may be 1 or 2 . The investigator hypothesizes that use of a higher number of features will correlate with a better outcome.
Participant Engagement: Completion Rates
Time frame: Daily average during treatment (up to 8 weeks)
Assessed by completion rates: the number of modules completed weekly. Rates may range from 0 to 7 modules completed each week. The investigator hypothesizes that completion of a higher number of modules weekly will correlate with a better outcome.
Study Retention: Surveys
Time frame: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)
Assessed by participant completion of survey measures at repeated timepoints (baseline, week 4, week 8, and week 12). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Study Retention: Daily Diaries
Time frame: Up to 8 weeks
Assessed by participant completion of daily diaries across 8 weeks of treatment (days 1-56). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Participant Satisfaction
Time frame: Post-treatment (up to 6 weeks post-treatment)
Assessed, once at the end of the program, via individual qualitative interviews or focus group sessions. Participants will be asked to evaluate the program by responding to the four items listed below, using a Likert scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree with possible score range 1-4) for the first three items and 1-10 (with 10 being definitely would recommend) for the fourth item.• The VR program was easy to use.• I enjoyed using the VR program.• The content in the VR program helped me cope with my pain.• On a scale of 1-10, how likely are you to recommend the VR program to someone else at this time? The investigator hypothesizes that responses of strongly agree and higher scores will correlate with a better outcome.
Frequency of Highest Satisfaction Scores
Time frame: Post-treatment (up to 6 weeks post-treatment)
Assessed once at the end of the program, via individual qualitative interviews or focus group sessions. Participants choosing the highest score for each of the four items listed will be counted. Higher number correlates with a better outcome.
Safety: Number of Adverse Events
Time frame: 4 weeks, 8 weeks, up to 6 weeks post-treatment
Assessed by monitoring participants for the number of adverse events. Fewer adverse events correlate with a better outcome.
18 secondary outcomes
Chronic Pain Acceptance Score
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Chronic Pain Self-Efficacy
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Social Support
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)
Pain Catastrophizing Score
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
BRIEF Health Literacy Score
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Executive Function
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Anxiety Levels
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Depression Levels
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Sleep Impact Short Form Score
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Functional Activities of Daily Living
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Chronic Pain Disability Score
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Average Healthcare Utilization
Time frame: Baseline
Number of Analgesics
Time frame: Time period 1 (days 1-28) and time period 2 (days 29-56)
Quality of Life: Frequency of Sickle Cell Pain Episodes
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Severity of Sickle Cell Pain Episodes
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Emotional Impact
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Social Functioning
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Quality of Life: Stiffness Impact
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42351762Matthie N, Higgins M, Jenerette C. Preliminary Benefits of In-Home Virtual Reality for Chronic Pain in Sickle Cell Disease: Pilot Randomized Trial. Biomedicines. 2026 Jun 12;14(6):1334. doi: 10.3390/biomedicines14061334.
- Individual participant dataSharing planned: Yes. * Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices) * Investigators whose proposed used of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose * For individual participant data meta-analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Matthie, PhD, RN, CNL principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EaseVRx and Audio-only version of EaseVRx in people with Sickle Cell Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Rating Using Numerical Pain Rating Scale (NPRS) (time frame: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04906707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.