跳至主要内容
临床试验/NCT04804462
NCT04804462已完成不适用

Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis

University of Washington2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Acceptability of Using Virtual Reality Meditation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a history of rheumatoid arthritis

排除标准

  • 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).

结局指标

主要结局

Acceptability of Using Virtual Reality Meditation

时间窗: 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.

Feasibility of Using Virtual Reality Meditation

时间窗: 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.

Experience of Using Virtual Reality Meditation

时间窗: 4 weeks

Qualitative interviews will aid exploration of participant's experience of using virtual reality meditation for rheumatoid-arthritis related fatigue.

次要结局

  • Brief Mood Introspection Scale (BMIS) Scored(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 v1.0 - Fatigue(4 weeks)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.2 - Physical Function(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan Dreesmann

Registered Nurse

University of Washington

研究点 (2)

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