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临床试验/NCT04743973
NCT04743973已完成不适用

A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing A Wearable Wellness Brain Sensing Device (Muse-S) in Practicing Physicians

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
40
试验地点
1
主要终点
Duration Adherence to Intervention

研究概览

简要总结

A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

详细描述

Participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. Subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. Subjects will also complete questionnaires and cognitive based testing throughout participation.

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

入选标准

  • •18 years of age or older at time of consent
  • •Practicing Physicians at Mayo Clinic
  • •Not pregnant by subject self-report at time of consent
  • •Have the ability to provide informed consent
  • •Have the ability to complete all aspects of this trial
  • •Have access to a smart phone or tablet device
  • •Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators

排除标准

  • •Used an investigational drug within the past 30 days
  • •Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
  • •Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress
  • •An unstable medical or mental health condition as determined by the physician investigator

研究组 & 干预措施

Practicing Physicians

Experimental

Practicing physicians at Mayo Clinic caring for patients during the COVID 19 pandemic will receive the Muse S™ Headband system, and will be asked to utilize it at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months (12 weeks).

干预措施: Muse S™ Headband system (Device)

结局指标

主要结局

Duration Adherence to Intervention

时间窗: 3 months

Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)

Frequency Adherence to Intervention

时间窗: 3 months

Summarizing frequency subjects use intervention during active study participation (during 3 month study period)

次要结局

  • Perceived Stress Scale (PSS) Score Difference(90 days)
  • Resilience Score Difference(90 days)
  • LASA Score Difference(90 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivana T Croghan, PhD

Principal Investigator

Mayo Clinic

研究点 (1)

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