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临床试验/NCT05519995
NCT05519995Unknown不适用

The Relationship Between Sensate II Utilization and Perceived Stress in Adults

BioSelf Technology1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
试验地点
1
主要终点
Perceived Stress

研究概览

简要总结

Sensate® is A commercially marketed (FCC #: 2AS9ESEN231) stress management wellness device (BioSelf Technology; London, UK). This non-invasive wellness device is one component of a cross-modal (acoustic and aural) sensory experience designed to help an individual experience relaxation following a 10 to 30-minute session. The wellness device is paired with an in-app software program that offers infrasonic vibrations that are proprietarily synced to music or soundscapes. The wellness device is recommended in blogs, and online news articles as a possible modality for positive stress management (Bergland, 2017; Woodhall, 2018; Woolton, 2018), and anecdotal evidence from social media influencers suggest a relaxing response (Garth, 2021; Knight, 2021; Patterson, 2020). Moreover, a 2021 survey response from consumers of Sensate suggests an improvement in stress response during the COVID-19 pandemic (McDoniel & Chmelik, 2022). However, it is unknown to what extent, if any, the use of Sensate II correlated with validated measures of stress, affect, or sleep quality in adults.

详细描述

This study aims to assess the possible relationship between Sensate II utilization (Frequency, Duration, & Time) and perceived stress, affect, and sleep quality in adults.

  1. Is there a relationship between Sensate II utilization and perceived stress
  2. Is there a relationship between Sensate II utilization and postive & negative affect
  3. Is there a relationship between Sensate II utilization and sleep quality. It is hypothesized that significant relationship existis between Sensate II utilization and perceived lower stress, higher postive affect, lower negative affect, and sleep quality.

References Bergland, C. (2017). Will stress-busting vagus nerve gadgetry be a game changer? Non-invasive vagus nerve stimulation reduces "fight-or-flight" stress responses. Psychology Today. http://www.psychologytoday.com/us/blog/the-athletes-way/201711/will-stress-busting-vagus-nerve-gadgetry-be-gamechanger

Garth, E. (2021). Review: Sensate stress and anxiety management. Longevity.Technology. http://longevity.technology/lifestyle/review-sensate/

Knight, S. (2021). Does the Sensate 2 do anything apart from vibrate your ribcage? http://www.makeuseof.com/sensate-review/

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Inclusion for this study will be adults (18+ years of age) who have been using the Sensate II device for stress management for a minimum of 30-days or one month.

排除标准

  • 未提供

结局指标

主要结局

Perceived Stress

时间窗: 1-month

Measure of perceived stress scale.

Sleep Quality

时间窗: 1-month

Measure of sleep quality

Postive Affect

时间窗: 1-month

Measure of positive Affect

Negative Affect

时间窗: 1-month

Measure of negative Affect

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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