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Virtual Reality Therapy for Chronic Pain in Sickle Cell Disease

N/A
Waitlist Available
Led By Nadine Matthie, PhD, RN, CNL
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Black adults, ages 18-50 years, with a diagnosis of SCD (Sickle cell disease)
Chronic non vaso-occlusive pain experienced > 3 days per week on average for > 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily during treatment (8 weeks) and monthly post-treatment (up to 6 weeks post-treatment)
Awards & highlights

Study Summary

This trial will test a new virtual reality intervention for chronic pain among young adults with sickle cell disease.

Who is the study for?
This trial is for Black adults aged 18-50 with sickle cell disease who experience chronic pain more than three days a week and can use VR equipment. It's not for those with conditions affecting pain perception, epilepsy, severe migraines, visual or hearing impairments, recent surgery, major uncontrolled psychiatric disorders, substance dependence, heart issues or implanted devices.Check my eligibility
What is being tested?
The study tests EaseVRx - an 8-week virtual reality program designed to help manage chronic pain at home. Participants will be randomly assigned to either the full version of EaseVRx or an audio-only variant to compare their effectiveness in self-managing sickle cell-related chronic pain.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing VR headsets like nausea or dizziness (cybersickness), headaches from flashing lights or motion graphics in the VR content and possible exacerbation of pre-existing neck or back problems due to headset movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a Black adult aged 18-50 with sickle cell disease.
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I have had chronic pain not related to blood flow issues for more than 6 months.
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I can wear a VR headset and move my head in all directions.
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I can use my hands to operate VR equipment like a controller.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily during treatment (8 weeks) and monthly post-treatment (up to 6 weeks post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily during treatment (8 weeks) and monthly post-treatment (up to 6 weeks post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Study Retention
Change in pain rating
Change in participant engagement: completion rates
+5 more
Secondary outcome measures
Change in BRIEF Health Literacy
Change in Chronic Pain Self-Efficacy
Change in Functional activities of daily living
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EaseVRx GroupExperimental Treatment1 Intervention
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.
Group II: Active control GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EaseVRx
2021
N/A
~100

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,628 Previous Clinical Trials
2,561,045 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
576 Previous Clinical Trials
10,375,063 Total Patients Enrolled
Nadine Matthie, PhD, RN, CNLPrincipal InvestigatorEmory University

Media Library

EaseVRx Clinical Trial Eligibility Overview. Trial Name: NCT04906707 — N/A
Sickle Cell Disease Research Study Groups: Active control Group, EaseVRx Group
Sickle Cell Disease Clinical Trial 2023: EaseVRx Highlights & Side Effects. Trial Name: NCT04906707 — N/A
EaseVRx 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906707 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the qualifications to join this research endeavor?

"The eligible candidates for this trial are those 18-50 years of age with anemia and sickle cell conditions. The medical study aims to enrol 72 participants."

Answered by AI

Is this investigation actively searching for participants who are over 60 years of age?

"Eligible participants must be aged 18-50 years."

Answered by AI

Is there an ongoing recruitment process for this clinical trial?

"As indicated on clinicaltrials.gov, this medical study is recruiting participants. This trial was first made public on October 27th 2021 and the information was most recently refreshed on April 19th 2022."

Answered by AI

How many participants have enrolled in the research project?

"Affirmative. Clinicaltrials.gov indicates that the medical trial was first posted on October 27th 2021 and is actively searching for 72 participants from 2 locations to join its research cohort."

Answered by AI

What are the main goals of this clinical research endeavor?

"The primary measure of this study's efficacy is the Change in Participant Engagement: Duration, which will be assessed on a daily basis over 8 weeks. Secondary outcomes include the Change in BRIEF Health Literacy (assessed by using a score-based tool ranging from 4 to 20), Change in Executive Function (measured with a 34-238 scale based on responses from never a problem to always a problem), and Change in Functional Activities of Daily Living (utilizing an assessment that ranges from 55 to > 70)."

Answered by AI
~20 spots leftby Mar 2025