Exploring the Effects of Muse and Spire on Stress Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of Spire and Muse on stress management. The study will be implemented as a 2-arm randomized controlled pilot study to assess the effect of either device on stress management from the end of baseline to closeout.
详细描述
Both Muse and Spire are recent technologies that could improve our understanding of stress management and enhance quality of healthcare. The goal of this study is to evaluate if Spire and Muse help individuals self-manage stress. Spire has been designed as a discrete clip-on tracker that monitors changes in respiration rate. With the companion app, this device displays breathing rates in real time and alerts the user through push notification in times of tension. Studies show that controlled breathing reduces stress. On the other hand, Muse is a headset device that uses EEG (electroencephalogram) sensors that measures electric brain frequencies. Muse guides the user in a form of simplified meditation by giving feedback in real time (i.e. calm, neutral, active) and audio clues to improve concentration. Previous studies have shown that engaging in meditation has the potential to reduce anxiety and stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Registered for Partners HealthCare Connected Health Symposium 2016
- •Over 18 years old
- •Able to read and speak English
- •Own a smartphone and have internet connection
- •Willing to wear a Spire device during all hours (except sleep)
- •Willing to use the Muse device (Group 2 ONLY)
- •Willing to participate in a research study and sign the consent form
排除标准
- •Not Registered for Partners HealthCare Connected Health Symposium 2016
- •Under 18 years old
- •Not able to read and speak English
- •Do not own a smartphone and have internet connection
- •Not willing to wear a Spire device during all hours (except sleep)
- •Not willing to use the Muse device (Group 2 ONLY)
- •Not willing to sign the consent form
结局指标
主要结局
Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
时间窗: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)
The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout. The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent's perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome). The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome).
次要结局
未报告次要终点
研究者
Joseph C. Kvedar
Dermatologist
Massachusetts General Hospital