Sickle Cell Disease
Conditions
Keywords
Pain management, Virtual Reality Device
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 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.
Interventions
DEVICEEaseVRx
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.
BEHAVIORALAudio-only version of EaseVRx
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.
Sponsors
National Institute of Nursing Research (NINR)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating Using Numerical Pain Rating Scale (NPRS) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Healthcare Utilization | Baseline | 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. |
| Number of Analgesics | Time period 1 (days 1-28) and time period 2 (days 29-56) | 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. |
| Quality of Life: Frequency of Sickle Cell Pain Episodes | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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. |
| Chronic Pain Acceptance Score | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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). |
| Quality of Life: Emotional Impact | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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. |
| Quality of Life: Social Functioning | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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. |
| Quality of Life: Stiffness Impact | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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. |
| Quality of Life: Severity of Sickle Cell Pain Episodes | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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. |
| Chronic Pain Self-Efficacy | Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12) | 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. |
| Social Support | Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks) | 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. |
| Pain Catastrophizing Score | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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). |
| BRIEF Health Literacy Score | Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12) | 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). |
| Executive Function | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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). |
| Anxiety Levels | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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. |
| Depression Levels | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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. |
| Sleep Impact Short Form Score | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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. |
| Functional Activities of Daily Living | Baseline, week 4, week 8 and 4 weeks post-intervention (week 12) | 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. |
| Chronic Pain Disability Score | Baseline, week 4, week 8, and 4 weeks post-intervention (week 12) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EaseVRx Group 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.
EaseVRx: 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. | 19 |
| Active Control Group 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.
Audio-only version of EaseVRx: 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. | 25 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
| Overall Study | Withdrawal due to PI decision | 1 | 0 |
Baseline characteristics
| Characteristic | EaseVRx Group | Total | Active Control Group |
|---|---|---|---|
| Age, Continuous | 36.37 years STANDARD_DEVIATION 6.67 | 33.73 years STANDARD_DEVIATION 7.5 | 31.72 years STANDARD_DEVIATION 7.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 42 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 41 Participants | 24 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 19 participants | 44 participants | 25 participants |
| Sex/Gender, Customized Female | 12 Participants | 27 Participants | 15 Participants |
| Sex/Gender, Customized Male | 7 Participants | 16 Participants | 9 Participants |
| Sex/Gender, Customized Transgender Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 25 |
| other Total, other adverse events | 1 / 19 | 0 / 25 |
| serious Total, serious adverse events | 0 / 19 | 0 / 25 |
Outcome results
Primary
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.
Time frame: Post-treatment (up to 6 weeks post-treatment)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EaseVRx Group | Frequency of Highest Satisfaction Scores | Participants with highest score for The program was easy to use | 7 Participants |
| EaseVRx Group | Frequency of Highest Satisfaction Scores | Participants with highest score for I enjoyed using the program | 6 Participants |
| EaseVRx Group | Frequency of Highest Satisfaction Scores | Participants with highest score for The content in the program helped me cope with my pain | 6 Participants |
| EaseVRx Group | Frequency of Highest Satisfaction Scores | Participants with highest score for how likely you to recommend the program to someone else? | 5 Participants |
| Active Control Group | Frequency of Highest Satisfaction Scores | Participants with highest score for how likely you to recommend the program to someone else? | 9 Participants |
| Active Control Group | Frequency of Highest Satisfaction Scores | Participants with highest score for The program was easy to use | 14 Participants |
| Active Control Group | Frequency of Highest Satisfaction Scores | Participants with highest score for The content in the program helped me cope with my pain | 12 Participants |
| Active Control Group | Frequency of Highest Satisfaction Scores | Participants with highest score for I enjoyed using the program | 13 Participants |
Primary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at Baseline | 66.84 score on a scale | Standard Deviation 12.64 |
| EaseVRx Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 4 weeks | 60.28 score on a scale | Standard Deviation 13.06 |
| EaseVRx Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 8 weeks | 56.33 score on a scale | Standard Deviation 13.65 |
| EaseVRx Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 12 weeks | 60.00 score on a scale | Standard Deviation 14.05 |
| Active Control Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 12 weeks | 45.96 score on a scale | Standard Deviation 20.54 |
| Active Control Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at Baseline | 63.07 score on a scale | Standard Deviation 15.84 |
| Active Control Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 8 weeks | 48.84 score on a scale | Standard Deviation 17.68 |
| Active Control Group | Pain Intensity Subscale of the Chronic Pain Grade Questionnaire | Pain Intensity score at 4 weeks | 54.06 score on a scale | Standard Deviation 16.24 |
Primary
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.
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)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Pain Rating Using Numerical Pain Rating Scale (NPRS) | NPRS daily score at up to week 4 or time period 1 (day 1-28) | 3.79 score on a scale | Standard Deviation 2.93 |
| EaseVRx Group | Pain Rating Using Numerical Pain Rating Scale (NPRS) | NPRS daily score from week 4 to 8, or time period 2 (days 29-56) | 2.37 score on a scale | Standard Deviation 2.77 |
| Active Control Group | Pain Rating Using Numerical Pain Rating Scale (NPRS) | NPRS daily score at up to week 4 or time period 1 (day 1-28) | 3.17 score on a scale | Standard Deviation 2.79 |
| Active Control Group | Pain Rating Using Numerical Pain Rating Scale (NPRS) | NPRS daily score from week 4 to 8, or time period 2 (days 29-56) | 2.63 score on a scale | Standard Deviation 2.78 |
Primary
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.
Time frame: Daily average during treatment (up to 8 weeks)
Population: Because of intermittent usage patterns, the average number of modules completed weekly could not be assessed for the Audio group (Active control group).~Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EaseVRx Group | Participant Engagement: Completion Rates | 2.38 modules/week |
Primary
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.
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)
Population: Lack of granularity in the VR device usage data (data provided monthly, not daily) limits the ability to identify specific usage patterns for reporting regarding duration in minutes each week. However, usage duration was self-reported by the VR group and the audio group. Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EaseVRx Group | Participant Engagement: Duration in Days | Time period 1 (days 1-28) | 1.38 days |
| EaseVRx Group | Participant Engagement: Duration in Days | Time period 2 (days 29-56) | 1.63 days |
| Active Control Group | Participant Engagement: Duration in Days | Time period 1 (days 1-28) | 2.75 days |
| Active Control Group | Participant Engagement: Duration in Days | Time period 2 (days 29-56) | 2.13 days |
Primary
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.
Time frame: Daily during treatment (8 weeks)
Population: Lack of granularity in the VR usage data limits the ability to identify specific usage patterns. Therefore, the average number of features utilized can only be reported across the 8 weeks of treatment. Participants who completed the corresponding survey for this outcome are included per timepoint.~This outcome was not applicable to the Audio group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EaseVRx Group | Participant Engagement: Features Utilized | Number of participants with 1 feature utilized | 6 Participants |
| EaseVRx Group | Participant Engagement: Features Utilized | Number of participants with 2 features utilized | 11 Participants |
Primary
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).
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)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EaseVRx Group | Participant Engagement: Minutes of Program Use Per Day | Time period 1 (days 1-28) | 170.5 Minutes of Program Use Per Day |
| EaseVRx Group | Participant Engagement: Minutes of Program Use Per Day | Time period 2 (days 29-56) | 243.0 Minutes of Program Use Per Day |
| Active Control Group | Participant Engagement: Minutes of Program Use Per Day | Time period 1 (days 1-28) | 128.5 Minutes of Program Use Per Day |
| Active Control Group | Participant Engagement: Minutes of Program Use Per Day | Time period 2 (days 29-56) | 163.25 Minutes of Program Use Per Day |
Primary
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.
Time frame: Post-treatment (up to 6 weeks post-treatment)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EaseVRx Group | Participant Satisfaction | On a scale of 1-10, how likely are you to recommend the program to someone else at this time? | 10.0 score on a scale |
| EaseVRx Group | Participant Satisfaction | I enjoyed using the program (Scale of 1-4) | 4.0 score on a scale |
| EaseVRx Group | Participant Satisfaction | The content in the program helped me cope with my pain (Scale of 1-4) | 4.0 score on a scale |
| EaseVRx Group | Participant Satisfaction | The program was easy to use (Scale of 1-4) | 4.0 score on a scale |
| Active Control Group | Participant Satisfaction | On a scale of 1-10, how likely are you to recommend the program to someone else at this time? | 10.0 score on a scale |
| Active Control Group | Participant Satisfaction | The program was easy to use (Scale of 1-4) | 4.0 score on a scale |
| Active Control Group | Participant Satisfaction | The content in the program helped me cope with my pain (Scale of 1-4) | 4.0 score on a scale |
| Active Control Group | Participant Satisfaction | I enjoyed using the program (Scale of 1-4) | 4.0 score on a scale |
Primary
Safety: Number of Adverse Events
Assessed by monitoring participants for the number of adverse events. Fewer adverse events correlate with a better outcome.
Time frame: 4 weeks, 8 weeks, up to 6 weeks post-treatment
Population: This outcome was only assessed in the EaseVRx Group because it was not applicable to the Audio group .Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EaseVRx Group | Safety: Number of Adverse Events | Number of Adverse events at 4 weeks | 2 adverse events |
| EaseVRx Group | Safety: Number of Adverse Events | Number of Adverse events at 8 weeks | 0 adverse events |
| EaseVRx Group | Safety: Number of Adverse Events | Number of adverse events at up to 6 weeks post-treatment | 0 adverse events |
Primary
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.
Time frame: Up to 8 weeks
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EaseVRx Group | Study Retention: Daily Diaries | 28 daily diaries |
| Active Control Group | Study Retention: Daily Diaries | 32 daily diaries |
Primary
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.
Time frame: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EaseVRx Group | Study Retention: Surveys | Baseline | 19 surveys completed |
| EaseVRx Group | Study Retention: Surveys | 4 weeks | 12 surveys completed |
| EaseVRx Group | Study Retention: Surveys | 8 weeks | 10 surveys completed |
| EaseVRx Group | Study Retention: Surveys | 4 weeks post-intervention (week 12) | 10 surveys completed |
| Active Control Group | Study Retention: Surveys | 4 weeks post-intervention (week 12) | 19 surveys completed |
| Active Control Group | Study Retention: Surveys | Baseline | 25 surveys completed |
| Active Control Group | Study Retention: Surveys | 8 weeks | 23 surveys completed |
| Active Control Group | Study Retention: Surveys | 4 weeks | 23 surveys completed |
Secondary
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.
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Anxiety Levels | Baseline | 53.19 T-score | Standard Deviation 9.33 |
| EaseVRx Group | Anxiety Levels | Week 4 | 52.65 T-score | Standard Deviation 10.21 |
| EaseVRx Group | Anxiety Levels | Week 8 | 47.72 T-score | Standard Deviation 8.45 |
| EaseVRx Group | Anxiety Levels | Week 12 | 50.03 T-score | Standard Deviation 11.14 |
| Active Control Group | Anxiety Levels | Week 12 | 52.56 T-score | Standard Deviation 10.83 |
| Active Control Group | Anxiety Levels | Baseline | 57.38 T-score | Standard Deviation 8.43 |
| Active Control Group | Anxiety Levels | Week 8 | 54.65 T-score | Standard Deviation 8.85 |
| Active Control Group | Anxiety Levels | Week 4 | 56.74 T-score | Standard Deviation 9.7 |
Secondary
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.
Time frame: Baseline
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EaseVRx Group | Average Healthcare Utilization | 2.5 healthcare visits |
| Active Control Group | Average Healthcare Utilization | 2.0 healthcare visits |
Secondary
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).
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | BRIEF Health Literacy Score | Baseline | 19.05 score on a scale | Standard Deviation 1.39 |
| EaseVRx Group | BRIEF Health Literacy Score | Week 4 | 19.00 score on a scale | Standard Deviation 1.79 |
| EaseVRx Group | BRIEF Health Literacy Score | Week 8 | 18.60 score on a scale | Standard Deviation 2.37 |
| EaseVRx Group | BRIEF Health Literacy Score | Week 12 | 19.00 score on a scale | Standard Deviation 1.89 |
| Active Control Group | BRIEF Health Literacy Score | Week 12 | 17.84 score on a scale | Standard Deviation 2.99 |
| Active Control Group | BRIEF Health Literacy Score | Baseline | 18.24 score on a scale | Standard Deviation 2.33 |
| Active Control Group | BRIEF Health Literacy Score | Week 8 | 17.04 score on a scale | Standard Deviation 3.01 |
| Active Control Group | BRIEF Health Literacy Score | Week 4 | 17.65 score on a scale | Standard Deviation 3.01 |
Secondary
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).
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Chronic Pain Acceptance Score | Baseline | 24.00 score on a scale | Standard Deviation 7.83 |
| EaseVRx Group | Chronic Pain Acceptance Score | Week 4 | 26.45 score on a scale | Standard Deviation 6.99 |
| EaseVRx Group | Chronic Pain Acceptance Score | Week 8 | 28.20 score on a scale | Standard Deviation 5.9 |
| EaseVRx Group | Chronic Pain Acceptance Score | Week 12 | 28.30 score on a scale | Standard Deviation 5.02 |
| Active Control Group | Chronic Pain Acceptance Score | Week 12 | 25.26 score on a scale | Standard Deviation 3.45 |
| Active Control Group | Chronic Pain Acceptance Score | Baseline | 21.40 score on a scale | Standard Deviation 5.97 |
| Active Control Group | Chronic Pain Acceptance Score | Week 8 | 23.65 score on a scale | Standard Deviation 6.73 |
| Active Control Group | Chronic Pain Acceptance Score | Week 4 | 23.43 score on a scale | Standard Deviation 4.8 |
Secondary
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).
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Chronic Pain Disability Score | Baseline | 56.14 score on a scale | Standard Deviation 26.42 |
| EaseVRx Group | Chronic Pain Disability Score | Week 4 | 48.06 score on a scale | Standard Deviation 21.67 |
| EaseVRx Group | Chronic Pain Disability Score | Week 8 | 39.33 score on a scale | Standard Deviation 17.9 |
| EaseVRx Group | Chronic Pain Disability Score | Week 12 | 43.00 score on a scale | Standard Deviation 14.61 |
| Active Control Group | Chronic Pain Disability Score | Week 12 | 42.81 score on a scale | Standard Deviation 27.45 |
| Active Control Group | Chronic Pain Disability Score | Baseline | 54.67 score on a scale | Standard Deviation 24.29 |
| Active Control Group | Chronic Pain Disability Score | Week 8 | 44.20 score on a scale | Standard Deviation 17.06 |
| Active Control Group | Chronic Pain Disability Score | Week 4 | 51.01 score on a scale | Standard Deviation 20.68 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Chronic Pain Self-Efficacy | Baseline | 154.68 score on a scale | Standard Deviation 27.7 |
| EaseVRx Group | Chronic Pain Self-Efficacy | Week 4 | 155.82 score on a scale | Standard Deviation 42.36 |
| EaseVRx Group | Chronic Pain Self-Efficacy | Week 8 | 166.40 score on a scale | Standard Deviation 31.01 |
| EaseVRx Group | Chronic Pain Self-Efficacy | Week 12 | 162.60 score on a scale | Standard Deviation 24.93 |
| Active Control Group | Chronic Pain Self-Efficacy | Week 12 | 160.89 score on a scale | Standard Deviation 39.33 |
| Active Control Group | Chronic Pain Self-Efficacy | Baseline | 155.92 score on a scale | Standard Deviation 32.6 |
| Active Control Group | Chronic Pain Self-Efficacy | Week 8 | 148.13 score on a scale | Standard Deviation 42.82 |
| Active Control Group | Chronic Pain Self-Efficacy | Week 4 | 151.52 score on a scale | Standard Deviation 35.25 |
Secondary
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.
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Depression Levels | Baseline | 48.96 T-score | Standard Deviation 8.66 |
| EaseVRx Group | Depression Levels | Week 4 | 48.59 T-score | Standard Deviation 7.78 |
| EaseVRx Group | Depression Levels | Week 8 | 45.99 T-score | Standard Deviation 9.71 |
| EaseVRx Group | Depression Levels | Week 12 | 45.05 T-score | Standard Deviation 8.71 |
| Active Control Group | Depression Levels | Week 12 | 49.15 T-score | Standard Deviation 9.56 |
| Active Control Group | Depression Levels | Baseline | 55.60 T-score | Standard Deviation 10.03 |
| Active Control Group | Depression Levels | Week 8 | 52.94 T-score | Standard Deviation 8.81 |
| Active Control Group | Depression Levels | Week 4 | 53.50 T-score | Standard Deviation 9.97 |
Secondary
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).
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Executive Function | Baseline BRIEF-A score | 78.53 score on a scale | Standard Deviation 24.02 |
| EaseVRx Group | Executive Function | BRIEF-A score at Week 8 | 79.00 score on a scale | Standard Deviation 25.83 |
| EaseVRx Group | Executive Function | BRIEF-A score at Week 4 | 76.27 score on a scale | Standard Deviation 26.41 |
| EaseVRx Group | Executive Function | BRIEF-A score at Week 12 | 75.90 score on a scale | Standard Deviation 17.65 |
| Active Control Group | Executive Function | BRIEF-A score at Week 12 | 79.74 score on a scale | Standard Deviation 28.17 |
| Active Control Group | Executive Function | Baseline BRIEF-A score | 98.12 score on a scale | Standard Deviation 28.5 |
| Active Control Group | Executive Function | BRIEF-A score at Week 4 | 83.00 score on a scale | Standard Deviation 25.71 |
| Active Control Group | Executive Function | BRIEF-A score at Week 8 | 92.43 score on a scale | Standard Deviation 28.8 |
Secondary
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.
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Functional Activities of Daily Living | Baseline | 49.65 T-score | Standard Deviation 6.39 |
| EaseVRx Group | Functional Activities of Daily Living | Week 4 | 51.77 T-score | Standard Deviation 7.07 |
| EaseVRx Group | Functional Activities of Daily Living | Week 8 | 51.54 T-score | Standard Deviation 6.86 |
| EaseVRx Group | Functional Activities of Daily Living | Week 12 | 52.59 T-score | Standard Deviation 8.62 |
| Active Control Group | Functional Activities of Daily Living | Week 12 | 49.44 T-score | Standard Deviation 9.78 |
| Active Control Group | Functional Activities of Daily Living | Baseline | 47.81 T-score | Standard Deviation 6.68 |
| Active Control Group | Functional Activities of Daily Living | Week 8 | 48.06 T-score | Standard Deviation 8.43 |
| Active Control Group | Functional Activities of Daily Living | Week 4 | 47.30 T-score | Standard Deviation 6.66 |
Secondary
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.
Time frame: Time period 1 (days 1-28) and time period 2 (days 29-56)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Number of Analgesics | Time period 1 (days 1-28) | 4.88 analgesics/day | Standard Deviation 3.35 |
| EaseVRx Group | Number of Analgesics | Time period 2 (days 29-56) | 4.86 analgesics/day | Standard Deviation 2.18 |
| Active Control Group | Number of Analgesics | Time period 1 (days 1-28) | 3.80 analgesics/day | Standard Deviation 3.01 |
| Active Control Group | Number of Analgesics | Time period 2 (days 29-56) | 4.69 analgesics/day | Standard Deviation 3.64 |
Secondary
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).
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Pain Catastrophizing Score | Baseline | 22.74 score on a scale | Standard Deviation 14.8 |
| EaseVRx Group | Pain Catastrophizing Score | Week 4 | 18.82 score on a scale | Standard Deviation 8.2 |
| EaseVRx Group | Pain Catastrophizing Score | Week 8 | 14.30 score on a scale | Standard Deviation 7.1 |
| EaseVRx Group | Pain Catastrophizing Score | Week 12 | 14.50 score on a scale | Standard Deviation 5.8 |
| Active Control Group | Pain Catastrophizing Score | Week 12 | 18.00 score on a scale | Standard Deviation 11.35 |
| Active Control Group | Pain Catastrophizing Score | Baseline | 25.48 score on a scale | Standard Deviation 10.78 |
| Active Control Group | Pain Catastrophizing Score | Week 8 | 19.26 score on a scale | Standard Deviation 9.63 |
| Active Control Group | Pain Catastrophizing Score | Week 4 | 21.91 score on a scale | Standard Deviation 11.8 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Quality of Life: Emotional Impact | Baseline | 51.70 T-score | Standard Deviation 7.8 |
| EaseVRx Group | Quality of Life: Emotional Impact | Week 4 | 54.56 T-score | Standard Deviation 8.54 |
| EaseVRx Group | Quality of Life: Emotional Impact | Week 8 | 55.13 T-score | Standard Deviation 8.66 |
| EaseVRx Group | Quality of Life: Emotional Impact | Week 12 | 54.06 T-score | Standard Deviation 6.92 |
| Active Control Group | Quality of Life: Emotional Impact | Week 12 | 52.84 T-score | Standard Deviation 8.66 |
| Active Control Group | Quality of Life: Emotional Impact | Baseline | 49.21 T-score | Standard Deviation 6.45 |
| Active Control Group | Quality of Life: Emotional Impact | Week 8 | 51.53 T-score | Standard Deviation 8.98 |
| Active Control Group | Quality of Life: Emotional Impact | Week 4 | 52.57 T-score | Standard Deviation 8.57 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Baseline | 51.85 T-score | Standard Deviation 8.39 |
| EaseVRx Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 4 | 50.08 T-score | Standard Deviation 8.22 |
| EaseVRx Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 8 | 48.74 T-score | Standard Deviation 10.81 |
| EaseVRx Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 12 | 47.96 T-score | Standard Deviation 9.69 |
| Active Control Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 12 | 42.23 T-score | Standard Deviation 12.58 |
| Active Control Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Baseline | 47.65 T-score | Standard Deviation 8.97 |
| Active Control Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 8 | 45.93 T-score | Standard Deviation 12.83 |
| Active Control Group | Quality of Life: Frequency of Sickle Cell Pain Episodes | Week 4 | 46.27 T-score | Standard Deviation 11.88 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Baseline | 52.79 T-score | Standard Deviation 7.66 |
| EaseVRx Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 4 | 49.32 T-score | Standard Deviation 10.36 |
| EaseVRx Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 8 | 50.42 T-score | Standard Deviation 9.01 |
| EaseVRx Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 12 | 48.55 T-score | Standard Deviation 6.06 |
| Active Control Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 12 | 44.54 T-score | Standard Deviation 8.51 |
| Active Control Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Baseline | 45.84 T-score | Standard Deviation 7.99 |
| Active Control Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 8 | 44.87 T-score | Standard Deviation 10.94 |
| Active Control Group | Quality of Life: Severity of Sickle Cell Pain Episodes | Week 4 | 46.19 T-score | Standard Deviation 9.72 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Quality of Life: Social Functioning | Baseline | 49.48 T-score | Standard Deviation 10.52 |
| EaseVRx Group | Quality of Life: Social Functioning | Week 4 | 56.04 T-score | Standard Deviation 4.56 |
| EaseVRx Group | Quality of Life: Social Functioning | Week 8 | 53.50 T-score | Standard Deviation 8.34 |
| EaseVRx Group | Quality of Life: Social Functioning | Week 12 | 57.82 T-score | Standard Deviation 5.97 |
| Active Control Group | Quality of Life: Social Functioning | Week 12 | 53.97 T-score | Standard Deviation 10.58 |
| Active Control Group | Quality of Life: Social Functioning | Baseline | 51.43 T-score | Standard Deviation 8.11 |
| Active Control Group | Quality of Life: Social Functioning | Week 8 | 51.92 T-score | Standard Deviation 8.94 |
| Active Control Group | Quality of Life: Social Functioning | Week 4 | 50.33 T-score | Standard Deviation 8.08 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Quality of Life: Stiffness Impact | Baseline | 47.73 T-score | Standard Deviation 6.62 |
| EaseVRx Group | Quality of Life: Stiffness Impact | Week 4 | 52.20 T-score | Standard Deviation 7.21 |
| EaseVRx Group | Quality of Life: Stiffness Impact | Week 8 | 52.02 T-score | Standard Deviation 7.76 |
| EaseVRx Group | Quality of Life: Stiffness Impact | Week 12 | 54.78 T-score | Standard Deviation 9.23 |
| Active Control Group | Quality of Life: Stiffness Impact | Week 12 | 50.48 T-score | Standard Deviation 7.56 |
| Active Control Group | Quality of Life: Stiffness Impact | Baseline | 45.78 T-score | Standard Deviation 7.63 |
| Active Control Group | Quality of Life: Stiffness Impact | Week 8 | 47.06 T-score | Standard Deviation 6.94 |
| Active Control Group | Quality of Life: Stiffness Impact | Week 4 | 46.58 T-score | Standard Deviation 6.13 |
Secondary
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.
Time frame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Sleep Impact Short Form Score | Week 12 | 55.37 T-score | Standard Deviation 6.15 |
| EaseVRx Group | Sleep Impact Short Form Score | Baseline | 49.03 T-score | Standard Deviation 7.04 |
| EaseVRx Group | Sleep Impact Short Form Score | Week 4 | 49.75 T-score | Standard Deviation 7.56 |
| EaseVRx Group | Sleep Impact Short Form Score | Week 8 | 52.91 T-score | Standard Deviation 5.68 |
| Active Control Group | Sleep Impact Short Form Score | Week 8 | 51.64 T-score | Standard Deviation 5.91 |
| Active Control Group | Sleep Impact Short Form Score | Week 12 | 51.88 T-score | Standard Deviation 7.17 |
| Active Control Group | Sleep Impact Short Form Score | Week 4 | 50.65 T-score | Standard Deviation 6.2 |
| Active Control Group | Sleep Impact Short Form Score | Baseline | 49.92 T-score | Standard Deviation 5.48 |
Secondary
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.
Time frame: Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)
Population: Participants who completed the corresponding survey for this outcome are included per timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EaseVRx Group | Social Support | Baseline SSQ score | 111.95 score on a scale | Standard Deviation 23.81 |
| EaseVRx Group | Social Support | Week 4 SSQ score | 116.55 score on a scale | Standard Deviation 27.26 |
| EaseVRx Group | Social Support | Week 8 SSQ score | 115.50 score on a scale | Standard Deviation 33.37 |
| EaseVRx Group | Social Support | Week 12 SSQ score | 121.90 score on a scale | Standard Deviation 19.94 |
| Active Control Group | Social Support | Week 12 SSQ score | 131.89 score on a scale | Standard Deviation 23.02 |
| Active Control Group | Social Support | Baseline SSQ score | 123.48 score on a scale | Standard Deviation 24.57 |
| Active Control Group | Social Support | Week 8 SSQ score | 121.52 score on a scale | Standard Deviation 22.78 |
| Active Control Group | Social Support | Week 4 SSQ score | 129.48 score on a scale | Standard Deviation 18.78 |