NCT05871411

Brief Summary

We spend a third of our life at work. Psychosocial risks (PSR) are a major issue in occupational health 1. Approaching the different dimensions of PSR calls on a dozen essential components: workload, autonomy, social support, burnout, anxiety, efforts made, rewards, work addiction, investment, etc. a specific questionnaire which usually contains 20 to 30 questions, so that having an overall view of PSR using the current reference questionnaires (Karasek, Siegrist, etc.) represents a total of more than 300 questions. The response time is thus incompatible with current medical practice (passage in the waiting room before the occupational health medical examination) and leads to a majority of non-responses during anonymous questionnaires on the Internet. On the other hand, these validated questionnaires were carried out by different people and are very heterogeneous between them, including in their formulation, so that the respondents have the impression of disorganization and anarchy. There is therefore a need for short, quick and uniform questionnaires. EVAs offer the incredible advantage of meeting these criteria: speed, uniformity, precision. From a data analysis point of view, EVAs also have the advantage of offering a continuous quantitative response, allowing the use of all statistical approaches. If some questionnaires have already been validated in the form of EVA, such as the EVA stress versus the " Perceived Stress Scale " questionnaire (PSS), the EVA workload and EVA autonomy at work versus the Karasek questionnaire, the other reference questionnaires are not yet validated in EVA (burnout, anxiety, efforts / rewards, work addiction, etc.).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

May 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

June 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

May 3, 2023

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (28)

  • Burnout

    Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Burnout

    Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Burnout

    Burnout using the Maslach Burn-out Inventory (MBI) questionnaire. MBI is composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items). The items are written in the form of statements about personal feelings or attitudes. Items are made of a 7-point scale frequency of feelings, varying from "never" to "every day". The scores for each component of the burn-out syndrome are considered separately and are not combined into a single total score. If desired for participant feedback, each score can be coded as low, average, or high

    Inclusion

  • Burnout

    Burnout using the Maslach Burn-out Inventory (MBI) questionnaire. MBI is composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items). The items are written in the form of statements about personal feelings or attitudes. Items are made of a 7-point scale frequency of feelings, varying from "never" to "every day". The scores for each component of the burn-out syndrome are considered separately and are not combined into a single total score. If desired for participant feedback, each score can be coded as low, average, or high

    One week later

  • Anxiety

    Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Anxiety

    Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Anxiety

    Anxiety using Hospital Anxiety and Depression (HAD) questionnaire. is a self-reported questionnaire composed of 14 items with a 4-point Likert scale assessing anxiety (7 items) and/or depressive (7 items) symptoms. For each subscale (anxiety and depression), total score ranges from 0 to 21. Higher scores indicate higher levels of anxiety or depressive symptoms. A score from 0 to 7 indicates the absence of disease, a score of 8-10 represents doubtful cases, and scores higher than 11 reflects the presence of a mood disorder.

    Inclusion

  • Anxiety

    Anxiety using Hospital Anxiety and Depression (HAD) questionnaire. is a self-reported questionnaire composed of 14 items with a 4-point Likert scale assessing anxiety (7 items) and/or depressive (7 items) symptoms. For each subscale (anxiety and depression), total score ranges from 0 to 21. Higher scores indicate higher levels of anxiety or depressive symptoms. A score from 0 to 7 indicates the absence of disease, a score of 8-10 represents doubtful cases, and scores higher than 11 reflects the presence of a mood disorder.

    One week later

  • Job demand

    Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Job demand

    Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Job control

    Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Job control

    Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Social support

    Social support on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Social support

    Social support on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Job demand / job control / social support

    Job demand / job control / social support using the Job Demand-Control-Support (JDSC) questionnaire of Karasek. JDSC assessed job demands, job control and social support through 26 items. The questionnaire measures nine items of job demands, nine items of job control and eight items of social support. Items of JDSC are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree. Among the 26 items, five negative statements require reverse scoring. From French data, the job strain threshold is set for a demands score higher than 20 and a control score lower than 71; the isostrain threshold is determined from a combining score of job strain and social support lower than 24.

    Inclusion

  • Job demand / job control / social support

    Job demand / job control / social support using the Job Demand-Control-Support (JDSC) questionnaire of Karasek. JDSC assessed job demands, job control and social support through 26 items. The questionnaire measures nine items of job demands, nine items of job control and eight items of social support. Items of JDSC are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree. Among the 26 items, five negative statements require reverse scoring. From French data, the job strain threshold is set for a demands score higher than 20 and a control score lower than 71; the isostrain threshold is determined from a combining score of job strain and social support lower than 24.questionnaire of Karasek

    One week later

  • Effort-reward imbalance

    Effort-reward imbalance on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Effort-reward imbalance

    Effort-reward imbalance on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Effort-reward imbalance

    Effort-reward imbalance using Effort-Reward Imbalance Questionnaire (ERI). ERI assessed psychological distress and health problems that may occur when there is an imbalance between the efforts required by the work and the rewards received. We used the 46 items of the French version of the ERI model exploring efforts (six items), over commitment (eleven items), and rewards (seventeen items). Items of ERI were scored on a five-point Likert-type scale, ranging from 1 = disagree to 5 = agree and very disturbed. A ratio extrinsic efforts and rewards can assess the imbalance between these two dimensions. A ratio greater than one defines employees exposed to an imbalance between efforts and rewards

    Inclusion

  • Effort-reward imbalance

    Effort-reward imbalance using Effort-Reward Imbalance Questionnaire (ERI). ERI assessed psychological distress and health problems that may occur when there is an imbalance between the efforts required by the work and the rewards received. We used the 46 items of the French version of the ERI model exploring efforts (six items), over commitment (eleven items), and rewards (seventeen items). Items of ERI were scored on a five-point Likert-type scale, ranging from 1 = disagree to 5 = agree and very disturbed. A ratio extrinsic efforts and rewards can assess the imbalance between these two dimensions. A ratio greater than one defines employees exposed to an imbalance between efforts and rewards

    One week later

  • Work addiction

    Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Work addiction

    Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Work addiction

    Work addiction using Work Addiction Risk Test (WART) questionnaire. The WART assesses 25 statements on a 4-point Likert scale from 1 - never true to 4 - always true. The total score ranged from 25 to 100, with higher scores reflecting higher work addiction. Scores from 25 to 56 were defined as low-risk of work addiction; from 57 to 66 as medium-risk and from 67 to 100 as high-risk .

    Inclusion

  • Work addiction

    Work addiction using Work Addiction Risk Test (WART) questionnaire. The WART assesses 25 statements on a 4-point Likert scale from 1 - never true to 4 - always true. The total score ranged from 25 to 100, with higher scores reflecting higher work addiction. Scores from 25 to 56 were defined as low-risk of work addiction; from 57 to 66 as medium-risk and from 67 to 100 as high-risk .

    One week later

  • Life satisfaction

    Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Inclusion

  • Life satisfaction

    Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    One week later

  • Life satisfaction

    Life satisfaction using the Minnesota Satisfaction Questionnaire (MSQ). MSQ is composed of 20 items designed to measure employee job satisfaction. Items are made of a 5-point scale of satisfaction, varying from 1 "Very dissatisfied" to 5 "Very satisfied". A percentile score of 75 or higher represent a high degree of satisfaction, a percentile score of 25 or lower represent a low degree of satisfaction and scores in the middle range of percentiles (26 to 74) indicated average satisfaction.

    Inclusion

  • Life satisfaction

    Life satisfaction using the Minnesota Satisfaction Questionnaire (MSQ). MSQ is composed of 20 items designed to measure employee job satisfaction. Items are made of a 5-point scale of satisfaction, varying from 1 "Very dissatisfied" to 5 "Very satisfied". A percentile score of 75 or higher represent a high degree of satisfaction, a percentile score of 25 or lower represent a low degree of satisfaction and scores in the middle range of percentiles (26 to 74) indicated average satisfaction.

    One week later

Secondary Outcomes (17)

  • Sociodemographic

    Once at inclusion

  • Occupation

    Once at inclusion

  • Work hours per week

    Once at inclusion

  • Night and weekend work

    Once at inclusion

  • Alcohol consumption

    Once at inclusion

  • +12 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a professional activity

You may qualify if:

  • All voluntary adults with a professional activity.

You may not qualify if:

  • Minor
  • Person not volunteer to participate.
  • Protected adults (curatorship, guardianship, safeguard of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Frédéric Dutheil

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 23, 2023

Study Start

June 13, 2023

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

August 6, 2024

Record last verified: 2024-07

Locations