Arthritis Pain Reduction in Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Adherence Measure
研究概览
简要总结
The goal of this clinical trial is to test using a pain and anxiety reduction phone application in older adults with knee osteoarthritis and chronic pain. The main questions it seeks to answer are:
- How acceptable is using a phone app in older adults with knee osteoarthritis and chronic pain to lower pain, pain stress and reduce fear of movement?
- What are the effects of combining biofeedback with a virtual reality nature scene and paced breath training to increase heart rate variability on pain and anxiety among older adults with knee osteoarthritis?
- What is the role of self-regulation and body awareness in predicting or strengthening the effect of combining virtual reality, heart rate variability biofeedback in older adults with knee osteoarthritis?.
Participants will be asked to:
- use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks.
- receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase.
- complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use.
- complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.
详细描述
Purpose: This single-group pre-post intervention design, study will explore the feasibility of using a multicomponent phone-based app for 8 weeks to reduce pain, pain stress effects, decreased heart rate variability and fear of movement in 24 older adults with knee osteoarthritis and to examine sustained use and or effects at 4 weeks after intervention period.
Aim 1 Evaluate the feasibility (adherence and satisfaction) of a multicomponent phone app combining virtual reality and heart rate variability biofeedback for use in older adults with knee osteoarthritis and chronic pain and gain descriptive evaluations of the experience in exit interviews.
Adherence: The adherence benchmark will be 80% of participants will participate at least 5 days per week during the initial 8-week intervention period. Adherence will be examined (not benchmarked) during the 4-week follow-up period.
Satisfaction: Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying.
Aim 2 Evaluate the preliminary effects of multicomponent phone app use (5 days a week for 8 weeks) in older adults with knee osteoarthritis, in relation to pain, pain stress effects, and fear of movement (kinesiophobia), and examine sustained use patterns and effects with only reminders from the app during the 4-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adults
- •Diagnosed osteoarthritis of the knee(s)
- •smart phone access
- •Pain scale rating of 4-10 on the numerical pain rating scale (0- 10) \
- •Pain duration of 3 months or greater
- •Score of 15 or greater on the Tampa Scale of Kinesiophobia (fear of movement) scale
- •Eligibility includes:
- •Willingness to engage in the study for 8 weeks
- •Being available for 1-3 phone calls for data collection at pre- and post-8-week intervention and at 4 weeks post-intervention conclusion
- •Exclusion criteria:
- •Self-report of: acute illness,
- •Systemic inflammatory disease (rheumatoid arthritis, lupus)
- •History of neurologic disease, seizure disorder,
- •Current or history of mental illness illness with hallucinations
- •Motion sickness or vestibular disorders
- •Acute or chronic respiratory disease
- •Dysrhythmic heart disease
- •Beta or calcium channel blocker medication use
- •Monovision \\
- •Current use of Heart rate variability training activities will also be excluded
排除标准
- 未提供
结局指标
主要结局
Adherence Measure
时间窗: 8 weeks
The adherence benchmark will be 80% of participants will participate at least 5 days per week during the initial 8-week intervention period. Adherence will be examined (not benchmarked) during the 4-week follow-up period
Satisfaction Measure
时间窗: 8-12 Weeks
Exit interviews will demonstrate that 80% of participants practicing with the phone app rate the experience as satisfying or highly satisfying
次要结局
- Heart Rate(Baseline, 4, 8 and 12 weeks)
- Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)(Baseline, 4, 8 and 12 weeks)
- Patient-reported outcomes measurement information -29 v2.0 system-29 Profile v2.0(Baseline, 4, 8 and 12 weeks)
- Multidimensional Assessment of Somatic Sense Scale(Baseline, 4, 8 and 12 weeks)
- Heart rate variability data(Baseline, 4, 8 and 12 weeks)
- Western Ontario and McMaster Universities Osteoarthritis Severity Index (WOMAC- Stiffness scale(Baseline, 4, 8 and 12 weeks)
- Customized Technology Adoption Survey(12th Week)
- Stanford Brief Activity Survey(Baseline, 4, 8 and 12 weeks)
- Post-Intervention Qualitative Interview(Between 8th and 12th Week)
研究者
Linda Larkey
Professor
Arizona State University