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Completed

NCT Number: NCT04804462

Virtual Reality Meditation for Fatigue

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.

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Key information

Conditions

Fatigue Arthritis Arthritis, Rheumatoid Autoimmune Diseases Chronic Pain Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheumatology Clinic at UW Medical Center - Roosevelt

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual Reality Meditation

Device

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Fatigue

    Time frame: 4 weeks

    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

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression

    Time frame: 4 weeks

    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

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety

    Time frame: 4 weeks

    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

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Pain Behavior

    Time frame: 4 weeks

    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

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function

    Time frame: 4 weeks

    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

  6. Brief Mood Introspection Scale (BMIS) Scored

    Time frame: 4 weeks

    The BMIS will be deployed using a computer-adaptive test (CAT) that will be emailed to participants.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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