FatigueNCT04804462
Virtual Reality Meditation for Fatigue
A study testing Virtual Reality Meditation in people with Fatigue and Rheumatoid Arthritis, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Rheumatoid Arthritis
- What is being tested?
- Virtual Reality Meditation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of rheumatoid arthritis
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rheumatology Clinic at UW Medical Center - Roosevelt
Seattle, Washington, 98105
About this study
Official title: Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Fatigue, Rheumatoid Arthritis
- Being tested
- Virtual Reality Meditation
- Keywords
- mindfulness, distraction, chronic pain, mixed methods, outpatient
- Medical subject headings
- Fatigue, Arthritis, Rheumatoid, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality MeditationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Meditation for Fatigue | Experimental | Participants will experience Virtual Reality Meditation in the comfort of their own home. Receives: Device: Virtual Reality Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (6)
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
Brief Mood Introspection Scale (BMIS) Scored
The BMIS will be deployed using a computer-adaptive test (CAT) that will be emailed to participants.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Aug 2019
- Primary completion1 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Dreesmann, University of Washington
- Investigators
- Nathan J Dreesman, PhD, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804462
- Sponsor's protocol ID
- STUDY00007661
- Other IDs
- TL1TR002318
- Status last verified
- May 2022
- First submitted
- 2 Jul 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dreesmann NJ, Buchanan D, Tang HJ, Furness Iii T, Thompson H. Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis: Mixed Methods Pilot Study. JMIR Form Res. 2023 Oct 17;7:e46209. doi: 10.2196/46209.
PubMed 37847542
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04804462
- Acronym / sponsor ID
- STUDY00007661
- Conditions
- Fatigue, Rheumatoid Arthritis
- Keywords
- mindfulness, distraction, chronic pain, mixed methods, outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will employ a convergent mixed-methods design with quantitative and qualitative data collection occurring concurrently throughout the study
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Meditation for Fatigue | Experimental | Device: Virtual Reality MeditationParticipants will experience Virtual Reality Meditation in the comfort of their own home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a history of rheumatoid arthritis
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality MeditationAfter 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. | Device | Virtual Reality Meditation for Fatigue |
Primary outcome
Feasibility of Using Virtual Reality Meditation
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
Qualitative interviews will aid exploration of participant's experience of using virtual reality meditation for rheumatoid-arthritis related fatigue.
6 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Fatigue
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Pain Behavior
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function
Time frame: 4 weeks
Brief Mood Introspection Scale (BMIS) Scored
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 37847542Dreesmann NJ, Buchanan D, Tang HJ, Furness Iii T, Thompson H. Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis: Mixed Methods Pilot Study. JMIR Form Res. 2023 Oct 17;7:e46209. doi: 10.2196/46209.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan J Dreesman, PhD, RN principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Meditation in people with Fatigue and Rheumatoid Arthritis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Using Virtual Reality Meditation (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.