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临床试验/NCT04897165
NCT04897165已完成不适用

Resilience Training With Mobile Heart Rate Variability Biofeedback for Work-related Stress in White-collar Employees and the Influence of the Lecture Format (Digital vs. Live) on Training Success

ARCIM Institute Academic Research in Complementary and Integrative Medicine2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
COPSOQ personal burnout after the intervention

研究概览

简要总结

A study to analyze the psychophysiological effects of a preventative, 4-week resilience training with mobile heart rate variability biofeedback (HRV-BfB) in a workplace setting and the influence of the lecture format (digital vs. live) on the training success.

详细描述

This was a three-arm, non-randomized, controlled trial to examine the effects of a preventative, 4-week resilience training with mobile HRV-BfB on work-related stress in white-collar employees. Participants were asked to exercise autonomously three times per day for five minutes with the mobile HRV-BfB device. They additionally attended three lectures at the beginning of the first, third, and forth week. The aim of the lectures was to mediate a theoretical knowledge and to prepare the participants for the autonomous training. To examine the potential influence of the lecture format, one group attended live lectures (blended learning condition) and one group received access to online lectures (e-learning condition). Results of study's outcome measures were compared with a waitlist control group. Outcome measures were assessed at baseline (T0), after the 4-week intervention (T1), and at 4-week follow-up (T2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Written informed consent
  • Employees of the company at which the study is conducted

排除标准

  • Implanted pacemaker
  • Medically diagnosed heart failure or arrhythmia
  • Medically prescribed cardiac drugs (e.g., beta-blockers, diuretics, ACE inhibitors, calcium channel blockers, or antiarrhythmic agents)

结局指标

主要结局

COPSOQ personal burnout after the intervention

时间窗: After the 4-week intervention (T1)

Personal burnout was assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T1. Six questions were answered on an ordinal scale, transformed to values ranging between 0=minimum value and 100=maximum value (higher values indicate a more severe burnout symptomatology) and averaged to obtain a scale score (0-100).

次要结局

  • Change in the COPSOQ scale personal burnout between baseline (T0) and 4-week follow-up (T2)(Baseline (T0) and 4-week follow-up (T2))
  • HRV analysis: Change in SDNN between baseline (T0) and after the 4-week intervention (T1)(Baseline (T0) and after the 4-week intervention (T1))
  • HRV analysis: Change in Baevsky's stress index between baseline (T0) and after the 4-week intervention (T1)(Baseline (T0) and after the 4-week intervention (T1))
  • Training evaluation(After the 4-week intervention (T1))
  • Change in the COPSOQ scale work-privacy conflict between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)(Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2))
  • HRV analysis: Change in RMSSD between baseline (T0) and after the 4-week intervention (T1)(Root mean square of successive differences (ms). Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).)
  • Change in the COPSOQ scale behavioral stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)(Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2))
  • Change in self-reported sleep quality between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)(Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2))
  • HRV analysis: Change in the degree of rhythmization between baseline (T0) and after the 4-week intervention (T1)(Baseline (T0) and after the 4-week intervention (T1))
  • Change in the COPSOQ scale cognitive stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)(Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2))
  • HRV analysis: Change in pNN50 between baseline (T0) and after the 4-week intervention (T1)(Baseline (T0) and after the 4-week intervention (T1))
  • Change in the COPSOQ scale subjective general health between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)(Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2))

研究者

发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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