- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05871411
Validation of Visual Analog Scales to Measure SatisfactiOn and WELL-being at Work (SoWell-VAS) (SoWell-VAS)
June 27, 2023 updated by: University Hospital, Clermont-Ferrand
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.).
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lise Laclautre
- Phone Number: 334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
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Clermont-Ferrand, France
- Recruiting
- Chu Clermont-Ferrand
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Contact:
- Lise Laclautre
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Principal Investigator:
- Frédéric DUTHEIL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adults with a professional activity
Description
Inclusion Criteria:
- All voluntary adults with a professional activity.
Exclusion Criteria:
- Minor
- Person not volunteer to participate.
- Protected adults (curatorship, guardianship, safeguard of justice)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burnout
Time Frame: Inclusion
|
Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Burnout
Time Frame: One week later
|
Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Burnout
Time Frame: Inclusion
|
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
Time Frame: One week later
|
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
Time Frame: Inclusion
|
Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Anxiety
Time Frame: One week later
|
Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Anxiety
Time Frame: Inclusion
|
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.
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Inclusion
|
Anxiety
Time Frame: One week later
|
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
Time Frame: Inclusion
|
Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Job demand
Time Frame: One week later
|
Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Job control
Time Frame: Inclusion
|
Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Job control
Time Frame: One week later
|
Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Social support
Time Frame: Inclusion
|
Social support on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
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Inclusion
|
Social support
Time Frame: One week later
|
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
Time Frame: Inclusion
|
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
Time Frame: One week later
|
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
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One week later
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Effort-reward imbalance
Time Frame: Inclusion
|
Effort-reward imbalance on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
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Inclusion
|
Effort-reward imbalance
Time Frame: One week later
|
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
Time Frame: Inclusion
|
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
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Inclusion
|
Effort-reward imbalance
Time Frame: One week later
|
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
Time Frame: Inclusion
|
Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Work addiction
Time Frame: One week later
|
Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Work addiction
Time Frame: Inclusion
|
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 .
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Inclusion
|
Work addiction
Time Frame: One week later
|
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
Time Frame: Inclusion
|
Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
Inclusion
|
Life satisfaction
Time Frame: One week later
|
Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
|
One week later
|
Life satisfaction
Time Frame: Inclusion
|
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.
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Inclusion
|
Life satisfaction
Time Frame: One week later
|
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.
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One week later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic
Time Frame: Once at inclusion
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age, gender, marital status, number of children, education level
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Once at inclusion
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Occupation
Time Frame: Once at inclusion
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Question "What is your profession?"
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Once at inclusion
|
Work hours per week
Time Frame: Once at inclusion
|
Number of hours worked per week
|
Once at inclusion
|
Night and weekend work
Time Frame: Once at inclusion
|
Do you work at night?
Do you work weekends?
|
Once at inclusion
|
Alcohol consumption
Time Frame: Once at inclusion
|
Number of alcoholic drinks per week
|
Once at inclusion
|
Tabacco consumption
Time Frame: Once at inclusion
|
Number of cigarettes per day
|
Once at inclusion
|
Height
Time Frame: Once at inclusion
|
Height in cm
|
Once at inclusion
|
Weight
Time Frame: Once at inclusion
|
Weight in kg
|
Once at inclusion
|
Sedentary behavior
Time Frame: Once at inclusion
|
Number of hours sit per day
|
Once at inclusion
|
Physical activity
Time Frame: Once at inclusion
|
Number of hours of physical activity per day
|
Once at inclusion
|
Stress at work
Time Frame: Once at inclusion
|
stress at work level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
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Once at inclusion
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Ethical conflicts
Time Frame: Once at inclusion
|
Ethical conflicts confrontation on a horizontal, non-calibrated line of 100 mm, ranging from never (0) to often(100)
|
Once at inclusion
|
Perceived health
Time Frame: Once at inclusion
|
Perceived health on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)
|
Once at inclusion
|
Stress at home
Time Frame: Once at inclusion
|
stress at home level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
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Once at inclusion
|
Fatigue
Time Frame: Once at inclusion
|
Fatigue level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)
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Once at inclusion
|
Sleep quality
Time Frame: Once at inclusion
|
Sleep quality level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)
|
Once at inclusion
|
Mood
Time Frame: Once at inclusion
|
mood level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)
|
Once at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frédéric Dutheil, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 3, 2023
First Submitted That Met QC Criteria
May 12, 2023
First Posted (Actual)
May 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2022 DUTHEIL
- 2022-A02450-43 (Other Identifier: 2022-A02450-43)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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