Feasibility Study and Validation of Measuring Apparatus Codesna Stress at Work (codesna)

There are different definitions of stress according to each discipline. In psychology, it is defined according to the individual's ability to adapt. The medical approach focuses on the reactions of the body to stress situations. And the organizational approach seeks to define in terms of sources of stress situations. According to a national interprofessional agreement on stress at work in 2008 is defined as a condition that occurs when there is an imbalance between the perception of a person with constraints imposed by its environment and the perception that it has its own resources to cope.

Stress at work

INRS emphasizes prevention to fight against the cost of work stress and seeks to develop methods and tools objectification stressful situations. The social cost of workplace stress would represent 10 to 20% of the expenses of the branch for employment injuries / occupational diseases of the Social Security According to a survey by the European Agency for Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all lost working days. The cost of occupational stress assessed by INRS represent 830 million euros in 2000 in France.

Media coverage of working conditions related suicides has prompted some companies to communicate about work stress and develop actions.

According to the study of Sumer in 2003, 61% of employees have a highly stressful job and 27% complained of work-related health problems.

However, the 2009 survey shows that job stress is a major risk factor for mental health and is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm, stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic stress as soon as possible to prevent burnout.

Stress testing procedures

The major problem is that there is not now comprehensively measure of stress. The measurement models that are available to date, all incomplete, can be classified according to two categories.

First, the general patterns that measure only partially stress but which can be used in any type of fields. One application of self-KARASEK and the imbalance of effort / reward SIEGRIST. These two models are mainly used for epidemiological studies on job stress.

Second, the specific models that provide a more comprehensive measure but we can only use in the area from which they come. These measure specific stressors (organizational, professional and emotional) in the study population.

The main objective of this study is evaluate the feasibility and validate the measurement of chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and KARASEK. This method explores finely enough constraints and allows a comparison of national data.

Study Overview

• Status: Completed
• Conditions: Stress, Physiological
• Intervention / Treatment: Device: Apparatus CODESNA

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire DITTLOT; Email: dittlot.c@chu-nice.fr
• Study Contact Backup: Name: claire VUAGNOUX; Email: vuagnoux.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signature of informed consent
• Belong to a social security scheme
• Working at the University Hospital of Nice

Exclusion Criteria:

• occurrence of an event particularly disturbing staff during the last six months
• raises annual leave of more than seven days in the last month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: apparatus CODESNA; correlation between job stress measurement by the Maslach Burnout INVENTORY and KARASEK questionnaires and measurement of chronic stress by CODESNA tool	Device: Apparatus CODESNA; The inclusion period is evaluated at one month and the participation of each patient is two days. One day or the subject performs the evaluation of chronic stress by CODESNA and following through questionnaires and another day to 3 weeks / one month apart, to perform a second chronic stress measurement with tool CODESNA to evaluate its reproducibility and reliability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the measured result by the CODESNA tool	The result of chronic Stress is expressed in% above the value 100. It measures the chronic stress in a universal scale for all human beings and using as reference the balance point of the autonomic nervous system. This shall be measured from the recording of R-R intervals of an ECG, also called Heart Rate Variability (HRV),,. Then the CODESNA algorithms perform mathematical processing being based physiological principle to deliver information Chronic Stress	1 month
the measured stress questionnaires collected by the Maslach Burnout INVENTORY scale	The result of the Maslach Burnout INVENTORY scale is a score	1 Month
the measured stress questionnaires collected by the KARASEK scale	The result of the KARASEK scale is a score	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimated): April 28, 2016

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 15-AOI-08; 2015-A00512-47 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No