Clinical trial NCT04804462: Virtual Reality Meditation for Fatigue
Official title: Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Rheumatoid Arthritis
Keywords: mindfulness
distraction
chronic pain
mixed methods
outpatient
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will employ a convergent mixed-methods design with quantitative and qualitative data collection occurring concurrently throughout the study
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Feasibility of Using Virtual Reality Meditation
timeFrame: 4 weeks
measure: Acceptability of Using Virtual Reality Meditation
timeFrame: 4 weeks
measure: Experience of Using Virtual Reality Meditation
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Fatigue
timeFrame: 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Depression
timeFrame: 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Anxiety
timeFrame: 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.0 - Pain Behavior
timeFrame: 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function
timeFrame: 4 weeks
measure: Brief Mood Introspection Scale (BMIS) Scored
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Rheumatology Clinic at UW Medical Center - Roosevelt
state: Washington
Study officials:
affiliation: University of Washington
name: Nathan J Dreesman, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: