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临床试验/NCT04381182
NCT04381182终止不适用

Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents

Joseph Maroon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
Change from baseline to two month heart rate variability

研究概览

简要总结

This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.

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

性别
All
接受健康志愿者
是

入选标准

  • •Neurosurgical Resident (UPMC)

排除标准

  • 未提供

研究组 & 干预措施

Biostrap/Apollo Device Use

Other

Participants wear a Biostrap wearable device which measures steps, heart rate, heart rate variability, sleep metrics, and quantitative data in typical day-to-day activities of residents. Participants then again wear Biostrap except now also with the Apollo device which is worn around the ankle and is suggested to modulate heart rate variability and perceived stress of participants.

干预措施: Apollo Wearable Device (Device)

结局指标

主要结局

Change from baseline to two month heart rate variability

时间窗: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Quantitative (average range, beats per minute)

Change from baseline to two month Perceived Stress Scale

时间窗: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress

Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)

时间窗: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.

次要结局

未报告次要终点

研究者

发起方
Joseph Maroon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joseph Maroon

Clinical Professor

University of Pittsburgh

研究点 (1)

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