Trial document




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  DRKS00014653

Trial Description

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Title

healthy leadership and work - body signals for managers and employees

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Managers and employees shall learn about psychosocial factors and their impact by measuring their heartbeat for 24 hours. Heart rate variability (HRV) is calculated, which describes the variation from heartbeat to another and corresponds to the activity of the sympathetic and parasympathetic nervous system. The results are shown in a graph and discussed with the occupational health physician. We want to investigate if the HRV measurement actually helps managers and employees to notice the impact of psychosocial factors. To implement the HRV measurement into the workplace setting, we develop a training for occupational health physicians and perform and evaluate it.

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Brief Summary in Scientific Language

The goal of the project is to translate a psychosomatic perspective into the workplace. For this purpose, we record a body signal - heart rate variability (HRV) - and integrate this signal in the psychosocial context of the manager/employee with the goal of a better understanding of interactions and sharpening of perception of these. Concretely, from 24 hours recordings of heart rate of managers and employees, HRV is calculated, interpreted and discussed by an occupational health physician. Because the measurement, calculation and interpretation of HRV (especially 24 hours HRV) needs special knowledge, the occupational health physicians need a training. We develop the training material, perform the training and supervise the cases. Hence, we have two main questions: Does the HRV measurement actually contribute to an improved psychosomatic comprehension of the managers and employees? Does the training enable the occupational health physicians to perform the HRV measurement, interpretation and consultation?

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014653
  •   2018/07/04
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  •   yes
  •   Approved
  •   188/18, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   general psychosomatic relations
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Interventions/Observational Groups

  •   Managers and employees presenting at the occupational health physician receive a 24 h recording of ECG and they are asked to fill in a diary of that day and a questionnaire. The latter contains standard demographical questions, questions about smoking, eating, relaxation and sports, psychosomatic interactions, SF-12 (short form health survey); Jenkins sleep questionnaire, irritation scale (IS), perceived health questionnaire (PHQ-4) and perceived stress scale (PSS-4). Afterwards, the occupational health physician analyses the ECG with regard to HRV and discusses the results with the manager/employee. The manager/employee is asked to fill in a questionnare regarding his satisfaction with the consultation and questions about psychosomatic interactions. It is possible to repeat the measurement and the consultation.
    The training for the occupational health physicians (OHP) is a whole day before measurements start. Meetings with case presentations are planned after 3, 6 and 12 months. The OHPs fill in a questionnaire at the first training day regarding their expectations of the HRV measurements and to evaluate the training day. After one year they fill in a questionnaire regarding effectivity and practicability of the HRV measurement and to evaluate the meetings and the supervision.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Outcome: Change in perception of psychosomatic connections pre/post

via a question in the questionnaire:
"I notice interactions between thoughts, Feelings and bodily reactions ... never - very often" (Scale from 1 to 10)

This question is asked before the HRV measurement and after the consultation

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Secondary Outcome

evaluation of occupational health physicians regarding effectivity and practicability of the HRV measurement

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/07/04
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

being a manager or employee at the cooperating company

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Exclusion Criteria

permanent cardiac arrhythmias (atrial fibrillation), pacemaker-dependent rhythm

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Addresses

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    • LPCU Kompetenzzentrum Ulm für seelische Gesundheit am Arbeitsplatz
    • Ms.  Dr. med.  Elisabeth  Balint 
    • Kornhausgasse 9
    • 89073  Ulm
    • Germany
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    • LPCU Kompetenzzentrum Ulm für seelische Gesundheit am Arbeitsplatz
    • Ms.  Dr. med.  Elisabeth  Balint 
    • Kornhausgasse 9
    • 89073  Ulm
    • Germany
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    • LPCU Kompetenzzentrum Ulm für seelische Gesundheit am Arbeitsplatz
    • Ms.  Dr. med.  Elisabeth  Balint 
    • Kornhausgasse 9
    • 89073  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Karl-Schlecht-Stiftung
    • Gutenbergstr. 4
    • 72631  Aichtal
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Ulm
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/12/20
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Trial Publications, Results and other Documents

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