Virtual Reality Meditation for Fatigue

NCT04804462 | Completed

• 2 other identifiers: STUDY00007661TL1TR002318
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Rheumatoid Arthritis

Keywords

mindfulness; distraction; chronic pain; mixed methods; outpatient

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 weeks

Secondary Outcomes (6)

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (1)

Virtual Reality Meditation for Fatigue

EXPERIMENTAL

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

Device: Virtual Reality Meditation

Interventions

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.

Virtual Reality Meditation for Fatigue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of rheumatoid arthritis

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Rheumatology Clinic at UW Medical Center - Roosevelt

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 37847542 DERIVED

MeSH Terms

Conditions

Fatigue; Arthritis, Rheumatoid; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nathan J Dreesman, PhD, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: This study will employ a convergent mixed-methods design with quantitative and qualitative data collection occurring concurrently throughout the study

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: March 18, 2021
• Study Start: August 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

US (1)