AzTrials
AzTrials

ValidationSoWell-VASNCT05871411

Validation of Visual Analog Scales to Measure SatisfactiOn and WELL-being at Work (SoWell-VAS)

An observational study of Validation and Visual Analogue Scale, run by University Hospital, Clermont-Ferrand at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
120 participants
Where
1 siteFrance
Study dates
13 Jun 2023to Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: Adults with a professional activity

Who may be able to join

  • All voluntary adults with a professional activity.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU clermont-ferrand

    Clermont-Ferrand

    Lise Laclautre

    Frédéric Dutheil

    Recruiting

Other trials in France

About this study

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.).

Medical subject headings
Occupational Stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout

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

    Measured: Inclusion

  2. Burnout

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

    Measured: One week later

  3. 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

    Measured: Inclusion

  4. 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

    Measured: One week later

  5. Anxiety

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

    Measured: Inclusion

  6. Anxiety

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

    Measured: One week later

  7. 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.

    Measured: Inclusion

  8. 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.

    Measured: One week later

  9. Job demand

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

    Measured: Inclusion

  10. Job demand

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

    Measured: One week later

  11. Job control

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

    Measured: Inclusion

  12. Job control

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

    Measured: One week later

  13. Social support

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

    Measured: Inclusion

  14. Social support

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

    Measured: One week later

  15. 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.

    Measured: Inclusion

  16. 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

    Measured: One week later

  17. Effort-reward imbalance

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

    Measured: Inclusion

  18. Effort-reward imbalance

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

    Measured: One week later

  19. 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

    Measured: Inclusion

  20. 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

    Measured: One week later

  21. Work addiction

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

    Measured: Inclusion

  22. Work addiction

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

    Measured: One week later

  23. 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 .

    Measured: Inclusion

  24. 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 .

    Measured: One week later

  25. Life satisfaction

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

    Measured: Inclusion

  26. Life satisfaction

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

    Measured: One week later

  27. 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.

    Measured: Inclusion

  28. 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.

    Measured: One week later

Secondary outcomes (17)
  1. Sociodemographic

    age, gender, marital status, number of children, education level

    Measured: Once at inclusion

  2. Occupation

    Question "What is your profession?"

    Measured: Once at inclusion

  3. Work hours per week

    Number of hours worked per week

    Measured: Once at inclusion

  4. Night and weekend work

    Do you work at night? Do you work weekends?

    Measured: Once at inclusion

  5. Alcohol consumption

    Number of alcoholic drinks per week

    Measured: Once at inclusion

  6. Tabacco consumption

    Number of cigarettes per day

    Measured: Once at inclusion

  7. Height

    Height in cm

    Measured: Once at inclusion

  8. Weight

    Weight in kg

    Measured: Once at inclusion

  9. Sedentary behavior

    Number of hours sit per day

    Measured: Once at inclusion

  10. Physical activity

    Number of hours of physical activity per day

    Measured: Once at inclusion

  11. Stress at work

    stress at work level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Measured: Once at inclusion

  12. Ethical conflicts

    Ethical conflicts confrontation on a horizontal, non-calibrated line of 100 mm, ranging from never (0) to often(100)

    Measured: Once at inclusion

  13. Perceived health

    Perceived health on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)

    Measured: Once at inclusion

  14. Stress at home

    stress at home level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)

    Measured: Once at inclusion

  15. Fatigue

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

    Measured: Once at inclusion

  16. Sleep quality

    Sleep quality level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)

    Measured: Once at inclusion

  17. Mood

    mood level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)

    Measured: Once at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start13 Jun 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05871411
Sponsor's protocol ID
RNI 2022 DUTHEIL
Other IDs
2022-A02450-43
Acronym
SoWell-VAS
Status last verified
Aug 2026
First submitted
3 May 2023
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Clinchamps M, Pereira B, Mermillod M, Charkhabi M, Zak M, Jiao J, Cole A, Bouillon-Minois JB, Dutheil F. Validation of visual analogue scales to assess occupational stress compared to the Karasek questionnaire: A cross sectional study. PLoS One. 2026 Feb 10;21(2):e0340209. doi: 10.1371/journal.pone.0340209. eCollection 2026.

    PubMed 41666222

Questions about this trial

What is this clinical trial studying?

An observational study of Validation and Visual Analogue Scale, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout (time frame: Inclusion). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05871411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in