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

NCT04906707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-04-20

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Matthie, PhD, RN, CNL · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2024-03-05
Completion
2024-03-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04906707 on ClinicalTrials.gov