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

NCT04906707 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY000020041R21NR019872-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Pain management; Virtual Reality Device

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (18)

• Chronic Pain Acceptance Score

  Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

• Chronic Pain Self-Efficacy

  Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)

• Social Support

  Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)

• Pain Catastrophizing Score

  Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

• BRIEF Health Literacy Score

  Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)

Study Arms (2)

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.

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.

Behavioral: Audio-only version of EaseVRx

Interventions

EaseVRx DEVICE

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.

EaseVRx Group

Audio-only version of EaseVRx BEHAVIORAL

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.

Active control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Grady Memorial Hospital - Outpatient Sickle Cell Clinic

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Agnosia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Nadine Matthie
• Organization: Emory University

nadine.matthie@emory.edu

404-712-8449

Study Officials

• Nadine Matthie, PhD, RN, CNL

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: May 28, 2021
• Study Start: October 27, 2021
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• 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.

Locations

US (1)