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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Device: EaseVRx; Behavioral: Audio-only version of EaseVRx

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital - Outpatient Sickle Cell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	4 weeks, 8 weeks, up to 6 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	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).	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).	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.	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.	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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Nadine Matthie, PhD, RN, CNL, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; Virtual Reality Device
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Chronic Pain; Anemia, Sickle Cell
• Other Study ID Numbers: STUDY00002004; 1R21NR019872-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No