Virtual Reality Meditation for Fatigue
Primary Purpose
Fatigue, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Meditation
Sponsored by
About this trial
This is an interventional other trial for Fatigue focused on measuring mindfulness, distraction, chronic pain, mixed methods, outpatient
Eligibility Criteria
Inclusion Criteria:
- Patients with a history of rheumatoid arthritis
Exclusion Criteria:
- Individuals with a past medical history of uncorrectable visual or auditory impairment, history of seizure disorder or seizure caused by technology use, extensive motion sickness, vestibular dysfunction, severe neck immobility, or excessive face or scalp sensitivity to pressure. These criteria were chosen as immersion and presence necessitate sufficient vision and hearing, technology use may cause side effects in persons with seizure history, severe motion sickness or vestibular dysfunction, neck immobility may decrease immersion and presence, and scalp sensitivity may inhibit use of a head-mounted device (HMD).
Sites / Locations
- Rheumatology Clinic at UW Medical Center - Roosevelt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality Meditation for Fatigue
Arm Description
Participants will experience Virtual Reality Meditation in the comfort of their own home.
Outcomes
Primary Outcome Measures
Feasibility of Using Virtual Reality Meditation
Completion percentage of quantitative questionnaires and an analysis of fidelity will provide insight into the feasibility of using virtual reality meditation for rheumatoid-arthritis related fatigue.
Acceptability of Using Virtual Reality Meditation
Qualitative interviews, paired with quantitative questionnaires, will inform the acceptability of both study procedures and measures of fatigue, anxiety, depression, pain behavior, physical functioning, and mood for use in outpatients with rheumatoid-arthritis.
Experience of Using Virtual Reality Meditation
Qualitative interviews will aid exploration of participant's experience of using virtual reality meditation for rheumatoid-arthritis related fatigue.
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Fatigue
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Pain Behavior
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Brief Mood Introspection Scale (BMIS) Scored
The BMIS will be deployed using a computer-adaptive test (CAT) that will be emailed to participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04804462
Brief Title
Virtual Reality Meditation for Fatigue
Official Title
Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 outpatient's experience of using VR-delivered meditation to manage fatigue.
Detailed Description
RA is a debilitating disease that affects over 1.3 million people in the U.S. 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 patient's experience of RA, fatigue, as well as experience of the virtual environment. This feasibility study's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Rheumatoid Arthritis
Keywords
mindfulness, distraction, chronic pain, mixed methods, outpatient
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will employ a convergent mixed-methods design with quantitative and qualitative data collection occurring concurrently throughout the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Meditation for Fatigue
Arm Type
Experimental
Arm Description
Participants will experience Virtual Reality Meditation in the comfort of their own home.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Meditation
Intervention Description
After donning the VR headset, participants will be able to use a handheld controller to choose from several virtual outdoor settings, three types of meditation, and three session lengths. After choosing their desired option, participants will experience virtual reality meditation in the desired virtual location, of the desired meditation type, and for the allotted duration chosen.
Primary Outcome Measure Information:
Title
Feasibility of Using Virtual Reality Meditation
Description
Completion percentage of quantitative questionnaires and an analysis of fidelity will provide insight into the feasibility of using virtual reality meditation for rheumatoid-arthritis related fatigue.
Time Frame
4 weeks
Title
Acceptability of Using Virtual Reality Meditation
Description
Qualitative interviews, paired with quantitative questionnaires, will inform the acceptability of both study procedures and measures of fatigue, anxiety, depression, pain behavior, physical functioning, and mood for use in outpatients with rheumatoid-arthritis.
Time Frame
4 weeks
Title
Experience of Using Virtual Reality Meditation
Description
Qualitative interviews will aid exploration of participant's experience of using virtual reality meditation for rheumatoid-arthritis related fatigue.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Fatigue
Description
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Time Frame
4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression
Description
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Time Frame
4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety
Description
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Time Frame
4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Pain Behavior
Description
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Time Frame
4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function
Description
Scores Range: 0-100; Uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric, a score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population.
PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. PROMIS measures for fatigue will be deployed using a computer-adaptive test (CAT) that will be emailed to participants. More information from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis
Time Frame
4 weeks
Title
Brief Mood Introspection Scale (BMIS) Scored
Description
The BMIS will be deployed using a computer-adaptive test (CAT) that will be emailed to participants.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a history of rheumatoid arthritis
Exclusion Criteria:
Individuals with a past medical history of uncorrectable visual or auditory impairment, history of seizure disorder or seizure caused by technology use, extensive motion sickness, vestibular dysfunction, severe neck immobility, or excessive face or scalp sensitivity to pressure. These criteria were chosen as immersion and presence necessitate sufficient vision and hearing, technology use may cause side effects in persons with seizure history, severe motion sickness or vestibular dysfunction, neck immobility may decrease immersion and presence, and scalp sensitivity may inhibit use of a head-mounted device (HMD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan J Dreesman, PhD, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Clinic at UW Medical Center - Roosevelt
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
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Virtual Reality Meditation for Fatigue
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