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

Occupational Stress Clinical Trial

— SoWell-VAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871411
• Other study ID #: RNI 2022 DUTHEIL
• Secondary ID: 2022-A02450-43
• Status: Recruiting
• Start date: June 13, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All voluntary adults with a professional activity.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Occupational Stress
• Validation

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burnout	Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Burnout	Burnout on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	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
Primary	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
Primary	Anxiety	Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Anxiety	Anxiety on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	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
Primary	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
Primary	Job demand	Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Job demand	Job demand on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	Job control	Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Job control	Job control on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	Social support	Social support on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Social support	Social support on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	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
Primary	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
Primary	Effort-reward imbalance	Effort-reward imbalance on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	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
Primary	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
Primary	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
Primary	Work addiction	Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Work addiction	Work addiction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	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
Primary	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
Primary	Life satisfaction	Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Inclusion
Primary	Life satisfaction	Life satisfaction on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	One week later
Primary	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
Primary	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	Sociodemographic	age, gender, marital status, number of children, education level	Once at inclusion
Secondary	Occupation	Question "What is your profession?"	Once at inclusion
Secondary	Work hours per week	Number of hours worked per week	Once at inclusion
Secondary	Night and weekend work	Do you work at night? Do you work weekends?	Once at inclusion
Secondary	Alcohol consumption	Number of alcoholic drinks per week	Once at inclusion
Secondary	Tabacco consumption	Number of cigarettes per day	Once at inclusion
Secondary	Height	Height in cm	Once at inclusion
Secondary	Weight	Weight in kg	Once at inclusion
Secondary	Sedentary behavior	Number of hours sit per day	Once at inclusion
Secondary	Physical activity	Number of hours of physical activity per day	Once at inclusion
Secondary	Stress at work	stress at work level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Once at inclusion
Secondary	Ethical conflicts	Ethical conflicts confrontation on a horizontal, non-calibrated line of 100 mm, ranging from never (0) to often(100)	Once at inclusion
Secondary	Perceived health	Perceived health on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)	Once at inclusion
Secondary	Stress at home	stress at home level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Once at inclusion
Secondary	Fatigue	Fatigue level on a horizontal, non-calibrated line of 100 mm, ranging from minimum (0) to maximum (100)	Once at inclusion
Secondary	Sleep quality	Sleep quality level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)	Once at inclusion
Secondary	Mood	mood level on a horizontal, non-calibrated line of 100 mm, ranging from bad(0) to excellent (100)	Once at inclusion