Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804462
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2019-07-02
Brief Title:
Virtual Reality Meditation for Fatigue
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the feasibility and acceptability of using virtual reality VR meditation to manage fatigue in outpatients with rheumatoid arthritis RA The specific aims of this feasibility study include 1 examining the feasibility of implementing VR meditation as an adjunct for managing fatigue in outpatients with rheumatoid arthritis 2 determine the acceptability of using VR-delivered meditation training for fatigue management in outpatients with rheumatoid arthritis and 3 is to explore outpatients experience of using VR-delivered meditation to manage fatigue
Detailed Description:
RA is a debilitating disease that affects over 13 million people in the US While recent advances in medicine have enhanced management of the disease a staggeringly large portion of outpatients with RA still suffer from fatigue A profound unrelenting exhaustion affecting energy motivation and concentration fatigue often develops over time without an inciting event Fatigue includes complex interactions between physiological psychological and behavioral processes making it not only insidious but difficult to treat Being multifaceted fatigue impacts depression mood and physical activity and can be exacerbated by pain and current treatment options target each of these correlates of fatigue Meditation has been extensively and effectively utilized in RA and other rheumatic diseases yet to date VR meditation has yet to be deployed in this population
This feasibility study will employ a mixed-methods design Thirty adult outpatients with clinically-diagnosed rheumatoid arthritis will be enrolled from a local rheumatology clinic and utilize VR in their own home Donning an Oculus Quest VR headset and using two handheld controllers patients will have the opportunity to choose from several virtual outdoor settings three types of meditation and three session lengths PROMIS measures of fatigue depression mood pain and physical activity will be collected at baseline and weekly intervals for the first 4 weeks after which an eight-week follow-up measure will be taken Semi-structured patient interviews will be used to capture patients experience of RA fatigue as well as experience of the virtual environment This feasibility studys results will address the acceptability desirability implementation practicality adaptation integration expansion and limited efficacy testing of utilizing VR meditation for managing fatigue in outpatients with RA
This feasibility study will employ a mixed-methods design Thirty adult outpatients with clinically-diagnosed rheumatoid arthritis will be enrolled from a local rheumatology clinic and utilize VR in their own home Donning an Oculus Quest VR headset and using two handheld controllers patients will have the opportunity to choose from several virtual outdoor settings three types of meditation and three session lengths PROMIS measures of fatigue depression mood pain and physical activity will be collected at baseline and weekly intervals for the first 4 weeks after which an eight-week follow-up measure will be taken Semi-structured patient interviews will be used to capture patients experience of RA fatigue as well as experience of the virtual environment This feasibility studys results will address the acceptability desirability implementation practicality adaptation integration expansion and limited efficacy testing of utilizing VR meditation for managing fatigue in outpatients with RA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TL1TR002318 | NIH | None | httpsreporternihgovquickSearchTL1TR002318 |