Virtual Reality Meditation for Fatigue

NCT ID: NCT04804462

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-06-01

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.

Conditions

Fatigue; Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Reality Meditation for Fatigue

Participants will experience Virtual Reality Meditation in the comfort of their own home.

Group Type: EXPERIMENTAL

Virtual Reality Meditation

Intervention Type: 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.

Interventions

Virtual Reality Meditation

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Nathan Dreesmann

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan J Dreesman, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Rheumatology Clinic at UW Medical Center - Roosevelt

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37847542 (View on PubMed)

Other Identifiers

TL1TR002318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007661

Identifier Type: -

Identifier Source: org_study_id