- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931406
Effects of a Sedentary Behaviors at Work on Health in Emergency Medical Dispatchers and CODIS Operators (SECODIS) (SECODIS)
Effects of a Sedentary Behaviors at Work on Health in Emergency Medical Dispatchers and CODIS Operators
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Each emergency medical services dispatcher and each firefighter participates in the study for three days. A normal working day from of 12h is compared to: (i) a working day during which the participants have to get up at least 5 min/hour (sit-and-stand desk), (ii) a working day during which they can use a cycloergometer installed under the desk. Conditions will be random using Latin Square design with stratification between sequences cross-over design on occupation (EMD vs. firefighters).
The heart rate variability (measured using Zephyr®), the electrodermal activity (Empatica® E4), the level of physical activity (Actigraph®) as well as the blood sugar (Freestyle®) will be measured continuously during the 12 hours of work and the night after except for Actigraph® and Freestyle® device that will be let one week. Blood and saliva samples will be collected at the beginning and end of each working day (6 samples in total). Participants will have to complete a detailed questionnaire to identify the particular events (vital emergencies, etc.) that may influence the parameters measured.
Participants will be asked to answer a general questionnaire once at the start of the study that will cover different aspects:
- Sociodemographic,
- Visual analogue scale (VAS) related to psychosocial factors : stress at home, burnout / burnout, decision latitude / autonomy at work, psychological demands at work (workload), support from the hierarchy, support from co-workers, family support, job satisfaction with regard to effort, commitment to work, addiction to work, quality of life, need for psychological support,
- Eating habits.
They will then have to answer a short questionnaire at the beginning and at the end of each measurement day. It will cover different aspects:
- Four VAS (stress level, fatigue, anxiety, mood),
- Physical activity and sedentary lifestyle (number of hours of physical activity and sitting during the last 24 hours),
- Daily consumption (tobacco, alcohol, cannabis, coffee, tea).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France
- CHU Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Emergency medical dispatchers or firefighters from the departmental fire and rescue operational center (CODIS).
- Person able to give an informed consent to participate in research
- Affiliated with a Social Security scheme.
Exclusion Criteria:
- Non-affiliated to a health insurance,
- Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice),
- Refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Emergency medical dispatchers
|
A normal working day from of 12h
a working day during which the participants have to get up at least 5 min/hour
a working day during which they can use a cycloergometer installed under the desk
|
Experimental: Firefighter
|
A normal working day from of 12h
a working day during which the participants have to get up at least 5 min/hour
a working day during which they can use a cycloergometer installed under the desk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary behavior
Time Frame: 12 hours of work corresponding to the control condition
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes per day standing/active.
|
12 hours of work corresponding to the control condition
|
Sedentary behavior
Time Frame: 12 hours of work corresponding to the sit-and-stand desk condition
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes per day standing/active.
|
12 hours of work corresponding to the sit-and-stand desk condition
|
Sedentary behavior
Time Frame: 12 hours of work corresponding to the cycloergometer condition
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes per day standing/active.
|
12 hours of work corresponding to the cycloergometer condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary behavior
Time Frame: one-week (168 hours) control cycle
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes per day standing/active.
|
one-week (168 hours) control cycle
|
Sedentary behavior
Time Frame: one-week (168 hours) sit-and-stand desk cycle
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes standing/active during one week.
|
one-week (168 hours) sit-and-stand desk cycle
|
Sedentary behavior
Time Frame: one-week (168 hours) cycloergometer cycle
|
Sedentary behavior measured by actimetry using Actigraph® in number of minutes standing/active during one week.
|
one-week (168 hours) cycloergometer cycle
|
Heart rate variabily
Time Frame: 24 hours record corresponding to 12 hours of work and the next 12 hours of rest
|
The heart rate variability measured using Zephyr®
|
24 hours record corresponding to 12 hours of work and the next 12 hours of rest
|
Electrodermal activity
Time Frame: 24 hours record corresponding to 12 hours of work and the next 12 hours of rest
|
The electrodermal activity measured using Empatica E4
|
24 hours record corresponding to 12 hours of work and the next 12 hours of rest
|
Stress at home
Time Frame: 8 am, beginning of the control day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the control day
|
Stress at home
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the sit-and-stand desk day
|
Stress at home
Time Frame: 8 am, beginning of the cycloergometer day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the cycloergometer day
|
Stress at home
Time Frame: 6 pm, end of the control day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the control day
|
Stress at home
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the sit-and-stand desk day
|
Stress at home
Time Frame: 6 pm, end of the cycloergometer day
|
Stress at home measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the cycloergometer day
|
Fatigue
Time Frame: 8 am, beginning of the control day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the control day
|
Fatigue
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the sit-and-stand desk day
|
Fatigue
Time Frame: 8 am, beginning of the cycloergometer day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the cycloergometer day
|
Fatigue
Time Frame: 6 pm, end of the control day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the control day
|
Fatigue
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the sit-and-stand desk day
|
Fatigue
Time Frame: 6 pm, end of the cycloergometer day
|
Fatigue measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the cycloergometer day
|
Anxiety
Time Frame: 8 am, beginning of the control day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the control day
|
Anxiety
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the sit-and-stand desk day
|
Anxiety
Time Frame: 8 am, beginning of the cycloergometer day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
8 am, beginning of the cycloergometer day
|
Anxiety
Time Frame: 6 pm, end of the control day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the control day
|
Anxiety
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the sit-and-stand desk day
|
Anxiety
Time Frame: 6 pm, end of the cycloergometer day
|
Anxiety measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
6 pm, end of the cycloergometer day
|
Mood
Time Frame: 6 pm, beginning of the control day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).
Higher scores mean a better outcome.
|
6 pm, beginning of the control day
|
Mood
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).Higher scores mean a better outcome.
|
8 am, beginning of the sit-and-stand desk day
|
Mood
Time Frame: 8 am, beginning of the cycloergometer day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).Higher scores mean a better outcome.
|
8 am, beginning of the cycloergometer day
|
Mood
Time Frame: 6 pm, end of the control day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).Higher scores mean a better outcome.
|
6 pm, end of the control day
|
Mood
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).Higher scores mean a better outcome.
|
6 pm, end of the sit-and-stand desk day
|
Mood
Time Frame: 6 pm, end of the cycloergometer day
|
Mood measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).Higher scores mean a better outcome.
|
6 pm, end of the cycloergometer day
|
Stress at work
Time Frame: 8 am, beginning of the control day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
8 am, beginning of the control day
|
Stress at work
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
8 am, beginning of the sit-and-stand desk day
|
Stress at work
Time Frame: 8 am, beginning of the cycloergometer desk day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
8 am, beginning of the cycloergometer desk day
|
Stress at work
Time Frame: 6 pm, end of the control day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
6 pm, end of the control day
|
Stress at work
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
6 pm, end of the sit-and-stand desk day
|
Stress at work
Time Frame: 6 pm, end of the cycloergometer day
|
Stress at work measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).Higher scores mean a worse outcome.
|
6 pm, end of the cycloergometer day
|
Amount of physical activity
Time Frame: 8 am, beginning of the control day
|
Number of hours of physical activity during the last 24 hours
|
8 am, beginning of the control day
|
Intensity of physical activity
Time Frame: 8 am, beginning of the control day
|
Physical activity intensity during the last 24 hours measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
8 am, beginning of the control day
|
Amount of physical activity
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Number of hours of physical activity during the last 24 hours
|
8 am, beginning of the sit-and-stand desk day
|
Intensity of physical activity
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Physical activity intensity during the last 24 hours measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
8 am, beginning of the sit-and-stand desk day
|
Amount of physical activity
Time Frame: 8 am, beginning of the cycloergometer day
|
Number of hours of physical activity during the last 24 hours
|
8 am, beginning of the cycloergometer day
|
Intensity of physical activity
Time Frame: 8 am, beginning of the cycloergometer day
|
Physical activity intensity during the last 24 hours measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
8 am, beginning of the cycloergometer day
|
Amount of physical activity
Time Frame: 6 pm, end of the control day
|
Number of hours of physical activity during the working day
|
6 pm, end of the control day
|
Intensity of physical activity
Time Frame: 6 pm, end of the control day
|
Physical activity intensity during the working day measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
6 pm, end of the control day
|
Amount of physical activity
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Number of hours of physical activity during the working day
|
6 pm, end of the sit-and-stand desk day
|
Intensity of physical activity
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Physical activity intensity during the working day measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
6 pm, end of the sit-and-stand desk day
|
Amount of physical activity
Time Frame: 6 pm, end of the cycloergometer day
|
Number of hours of physical activity during the working day
|
6 pm, end of the cycloergometer day
|
Intensity of physical activity
Time Frame: 6 pm, end of the cycloergometer day
|
Physical activity intensity during the working day measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a higher intensity.
|
6 pm, end of the cycloergometer day
|
Sitting time
Time Frame: 8 am, beginning of the control day
|
Number of hours sit during the last 24 hours
|
8 am, beginning of the control day
|
Sitting time
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Number of hours sit during the last 24 hours
|
8 am, beginning of the sit-and-stand desk day
|
Sitting time
Time Frame: 8 am, beginning of the cycloergometer day
|
Number of hours sit during the last 24 hours
|
8 am, beginning of the cycloergometer day
|
Sitting time
Time Frame: 6 pm, end of the control day
|
Number of hours sit during the working day
|
6 pm, end of the control day
|
Sitting time
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Number of hours sit during the working day
|
6 pm, end of the sit-and-stand desk day
|
Sitting time
Time Frame: 6 pm, end of the cycloergometer day
|
Number of hours sit during the working day
|
6 pm, end of the cycloergometer day
|
Tabacco consumption
Time Frame: 8 am, beginning of the control day
|
Number of cigarette during the last 24h
|
8 am, beginning of the control day
|
Tabacco consumption
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Number of cigarette during the last 24h
|
8 am, beginning of the sit-and-stand desk day
|
Tabacco consumption
Time Frame: 8 am, beginning of the cycloergometer day
|
Number of cigarette during the last 24h
|
8 am, beginning of the cycloergometer day
|
Tabacco consumption
Time Frame: 6 pm, end of the control day
|
Number of cigarette during the working day
|
6 pm, end of the control day
|
Tabacco consumption
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Number of cigarette during the working day
|
6 pm, end of the sit-and-stand desk day
|
Tabacco consumption
Time Frame: 6 pm, end of the cycloergometer day
|
Number of cigarette during the working day
|
6 pm, end of the cycloergometer day
|
Tea consumption
Time Frame: 8 am, beginning of the control day
|
Number of cups of tea during the last 24h
|
8 am, beginning of the control day
|
Tea consumption
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Number of cups of tea during the last 24h
|
8 am, beginning of the sit-and-stand desk day
|
Tea consumption
Time Frame: 8 am, beginning of the cycloergometer day
|
Number of cups of tea during the last 24h
|
8 am, beginning of the cycloergometer day
|
Tea consumption
Time Frame: 6 pm, end of the control day
|
Number of cups of tea during the last 24h
|
6 pm, end of the control day
|
Tea consumption
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Number of cups of tea during the last 24h
|
6 pm, end of the sit-and-stand desk day
|
Tea consumption
Time Frame: 6 pm, end of the cycloergometer day
|
Number of cups of tea during the last 24h
|
6 pm, end of the cycloergometer day
|
Coffee consumption
Time Frame: 8 am, beginning of the control day
|
Number of cups of coffee during the last 24h
|
8 am, beginning of the control day
|
Coffee consumption
Time Frame: 8 am, beginning of the sit-and-stand desk day
|
Number of cups of coffee during the last 24h
|
8 am, beginning of the sit-and-stand desk day
|
Coffee consumption
Time Frame: 8 am, beginning of the cycloergometer day
|
Number of cups of coffee during the last 24h
|
8 am, beginning of the cycloergometer day
|
Coffee consumption
Time Frame: 6 pm, end of the control day
|
Number of cups of coffee during the working day
|
6 pm, end of the control day
|
Coffee consumption
Time Frame: 6 pm, end of the sit-and-stand desk day
|
Number of cups of coffee during the working day
|
6 pm, end of the sit-and-stand desk day
|
Coffee consumption
Time Frame: 6 pm, end of the cycloergometer day
|
Number of cups of coffee during the working day
|
6 pm, end of the cycloergometer day
|
Sociodemographic
Time Frame: Once at baseline
|
Sociodemographic will be assessed: gender, age, marital status, children, occupation, and recent stressful event
|
Once at baseline
|
Sleep quality
Time Frame: Once at baseline
|
Sleep quality measured using visual analogue scale ranging from 0 (Bad) to 100 (Excellent).
Higher scores mean a better outcome.
|
Once at baseline
|
Familly support
Time Frame: Once at baseline
|
Family support measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a better outcome.
|
Once at baseline
|
Burnout
Time Frame: Once at baseline
|
Burnout measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
Once at baseline
|
Job demand
Time Frame: Once at baseline
|
Job demand measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a worse outcome.
|
Once at baseline
|
Job control
Time Frame: Once at baseline
|
Job control measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a better outcome.
|
Once at baseline
|
Hierarchy support
Time Frame: Once at baseline
|
Hierarchy support measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a better outcome.
|
Once at baseline
|
Colleagues support
Time Frame: Once at baseline
|
Colleagues support measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a better outcome.
|
Once at baseline
|
Effort reward-imbalance
Time Frame: Once at baseline
|
Effort reward-imbalance measured using visual analogue scale ranging from 0 (Minimum) to 100 (Maximum).
Higher scores mean a better outcome.
|
Once at baseline
|
Medical treatment
Time Frame: Once at baseline
|
Medical treatment measured using multi-choice question "do you take long terme medication?"
|
Once at baseline
|
Allergy
Time Frame: Once at baseline
|
Allergy measured using multi-choice question "do you have allergy?"
|
Once at baseline
|
Average physical activity
Time Frame: Once at baseline
|
Average number of hours of physical activity per week
|
Once at baseline
|
Average physical activity intensity
Time Frame: Once at baseline
|
Average physical activity intensity per week
|
Once at baseline
|
Average tabacco consumption
Time Frame: Once at baseline
|
Average number of cigarette per day
|
Once at baseline
|
Average alcohol consumption
Time Frame: Once at baseline
|
Average number of alcohol glasses per week
|
Once at baseline
|
Average cannabis consumption
Time Frame: Once at baseline
|
Average number of cannabis joint per week
|
Once at baseline
|
Average tea consumption
Time Frame: Once at baseline
|
Average number of cup of tea per day
|
Once at baseline
|
Average coffee consumption
Time Frame: Once at baseline
|
Average number of cup of coffee per day
|
Once at baseline
|
Average food consumption
Time Frame: Once at baseline
|
Average food consumption of 16 food group
|
Once at baseline
|
Diet characterization
Time Frame: Once at baseline
|
"How do you characterize your diet" measured on a visual analogue scale ranging from 0 (Not at all balanced) to 100 (Very balanced)
|
Once at baseline
|
Average burnout level
Time Frame: Once at baseline
|
Average burnout level measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average job control level
Time Frame: Once at baseline
|
Average job control level measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average hierarchy support
Time Frame: Once at baseline
|
Average hierarchy support measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average colleagues support
Time Frame: Once at baseline
|
Average colleagues support measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average family support
Time Frame: Once at baseline
|
Average family support measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average effort reward imbalance
Time Frame: Once at baseline
|
Average effort reward imbalance measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
Average sleep quality
Time Frame: Once at baseline
|
Average sleep quality imbalance measured on a visual analogue scale ranging from 0 (Minimum) to 100 (Maximum)
|
Once at baseline
|
RPAQ questionnaire
Time Frame: Once at baseline
|
The Recent Physical Activity Questionnaire (RPAQ) assesses the level of physical activity and sedentary lifestyle in adults over the past four weeks.
It is divided into three parts: work and study, home and leisure, and finally, stairs and travel.
It makes it possible to classify individuals into several categories, one on sedentary lifestyle (low, resistant either 3-7h/day or high or >7h/day) and one on the level of physical activity (<8.3 MET.hour/week: inactive or >8.3 MET.h/wk: active).
|
Once at baseline
|
MBI questionnaire
Time Frame: Once at baseline
|
The Maslach Burn-out Inventory (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.
If desired for participant feedback, each score can be coded as low, average, or high.
|
Once at baseline
|
JDSC questionnaire
Time Frame: Once at baseline
|
The Job Demand-Control-Support (JDSC) questionnaire of Karasek 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 JCQ 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.
We would ask the participants to fulfil the questionnaire from memories that they keep of their work.
|
Once at baseline
|
ERI questionnaire
Time Frame: Once at baseline
|
The Effort-Reward Imbalance Questionnaire (ERI) is a self-administrated test assessing 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.
|
Once at baseline
|
Salivary cortisol
Time Frame: Once at baseline
|
Salivary cortisol measured in µg/dl
|
Once at baseline
|
Blood cortisol
Time Frame: Once at baseline
|
Blood cortisol measured in ng/ml or nmol/l
|
Once at baseline
|
Salivary DHEAS
Time Frame: Once at baseline
|
Salivary DHEAS measured in pg/ml
|
Once at baseline
|
Blood DHEAS
Time Frame: Once at baseline
|
Blood DHEAS measured in µg/ml
|
Once at baseline
|
Salivary leptin
Time Frame: Once at baseline
|
Salivary leptin measured in ng/ml
|
Once at baseline
|
Blood leptin
Time Frame: Once at baseline
|
Blood leptin measured in ng/ml
|
Once at baseline
|
Salivary ghrelin
Time Frame: Once at baseline
|
Salivary ghrelin measured in ng/ml
|
Once at baseline
|
Blood ghrelin
Time Frame: Once at baseline
|
Blood ghrelin measured in pg/ml
|
Once at baseline
|
Blood BDNF
Time Frame: Once at baseline
|
Blood brain-derived neurotrophic factor (BDNF) measured in pg/ml
|
Once at baseline
|
Blood pro-inflammatory cytokines
Time Frame: Once at baseline
|
Blood pro-inflammatory cytokines measured in pg/ml
|
Once at baseline
|
Blood NPY
Time Frame: Once at baseline
|
Blood vascular distribution of neuropeptide Y (NPY) measured in pg/ml
|
Once at baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fréderic DUTHEIL, fdutheil@chu-clermontferrand.fr
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2022 DUTHEIL
- 2022-A02730-43 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Occupational Stress
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
University of Social Sciences and Humanities, WarsawLinkoeping University; Stockholm UniversityCompletedBurnout, Professional | Stress, Psychological, OccupationalPoland
-
Taichung Veterans General HospitalUnknown
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain
-
Centre Hospitalier Universitaire de BesanconCentre hospitalier de l'Université de Montréal (CHUM); Laboratoire de psychologie... and other collaboratorsUnknown
-
Maharishi International UniversityCenter for Wellness and Achievement in EducationCompletedJob Stress | Perceived Stress
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Cairo UniversityEnrolling by invitation
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryNot yet recruiting
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted