Skip to main content
Clinical Trials/NCT04897165
NCT04897165CompletedNot Applicable

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 sites in 1 country90 target enrollmentStarted: October 4, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
COPSOQ personal burnout after the intervention

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

COPSOQ personal burnout after the intervention

Time Frame: 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).

Secondary Outcomes

  • 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))

Investigators

Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials