Má asistence ekologického řízení (EDA) vliv na zdraví a pohodu řidiče autobusu?
Má asistence ekologického řízení (EDA) vliv na zdraví a pohodu řidiče autobusu? Pseudorandomizovaná kontrolovaná studie
The goal of this pragamatic trial is to assess the impact of eco-driving assistance (EDA) system on professional bus drivers' health and well-being.
The main questions it aims to answer are:
- Does the eco-driving assistance (EDA) act as a stressor for bus drivers ?
- Does the physiological and psychological perceived stress increase when bus drivers are driving bus equipped with eco-driving assistance (EDA) ?
An additional question consists in assessing the association between stress measurements and biomarkers in biological samples.
Researchers will compare the heart rate variability (HRV) and perceived stress level when participant are allocated to EDA-equipped buses and non-EDA-equipped buses
Participants will:
- Drive buses equipped with eco-driving assistance (EDA)
- Drive buses without eco-driving assistance (EDA)
- Wear a wearable electrocardiogram (ECG) device (Bittium Faros) to record the heart rate variability (HRV)
- Answer a questionnaire at the end of each working day (end-of-service questionnaire)
- When allocated to bus with eco-driving assistance (EDA), read the EDA-generated report and answer some related questions in the end-of-service questionnaire
- Upon acceptance only, a collection of biological samples and physiological measurement will be performed
Přehled studie
Detailní popis
This pragmatic pseudo-randomized trial will allow the investigators to assess the effect of eco-driving assistance (EDA) on bus drivers' health and well-being. Each bus driver will be randomly allocated to either buses equipped with eco-driving assistance (EDA) (i.e. intervention) and buses without eco-driving assistance (EDA) (i.e. control). The research team will use the within-subject design, allowing to allocate both the intervention and the control to each participant.
Throughout the working day, each bus driver will continuously wear an ECG device (Bittium Faros) to record the HRV. At the end of each working day, participants will receive a questionnaire (i.e. end-of-service questionnaire) to fill in. If they have been allocated to at least one EDA-equipped bus during their working day, they will need to read the EDA-generated report and come back to the questionnaire to fill in additionnal questions.
To record enough data, participants will need to reach at least 5 hours driving shifts with an EDA-equipped bus and 5 hours driving shifts without EDA. When this endpoint is reached, the study is over.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Canton of Fribourg
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Givisiez, Canton of Fribourg, Švýcarsko, 1762
- TPF
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- adult active bus driver
- having signed the informed consent
- having worked for at least one year as TPF bus driver
- working at least 30 hours a week
- no planned extended absences in the next 6 months (civil service, military service, long- term leave, retirement)
Exclusion Criteria:
- wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
- known allergy or skin sensitivity to plasters
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: EDA
Driving shifts with EDA-equipped buses |
Eco-driving assistance (EDA) systems is a technology integrated into vehicles that helps drivers to optimize fuel efficiency and reduce emissions by providing real-time feedback and guidance on driving behaviors. The system typically analyzes several driving behaviours that are measured using different captors and sensors. These systems aim to reduce the overall carbon footprint of driving, leading to cost savings for the public transport company and reduced environmental impact. |
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Žádný zásah: Control
Driving shifts with non-EDA-equipped buses |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Heart rate variability (HRV)
Časové okno: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
|
Heart rate variability (HRV) will be measured using the Bittium Faros ECG device. Participants will continuously wear the device throughout their working day and during one full non-working night, to obtain baseline value. |
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived stress
Časové okno: 1 day at the beginning of the study, once the eligibility has been confirmed
|
Perceived stress will be assessed with the validated perceived stress scale questionnaire included in the baseline questionnaire, filled at the begining of the study, once the eligibility has been confirmed. For each question participants will choose from the following alternatives: 0 = never; 1 = almost never; 2 = sometimes; 3 = fairly often, 4 = very often |
1 day at the beginning of the study, once the eligibility has been confirmed
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Perceived stress
Časové okno: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
|
Visual analog scale (VAS) for perceived stress during their working days included in the daily end-of-service questionnaire Scale from 0 to 100, with 0 = no stress and 100 = maximal stress |
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
|
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Perceived stress
Časové okno: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
|
Specific questions related to any stessful events encountered during the participant's working days included in the end-of-service questionnaire |
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
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Stress biomarkers in saliva samples
Časové okno: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
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Saliva auto-collection (upon acceptance only) by participants to further measure cortisone and cortisol and correlate their levels with any participant reported stressful events in the end-of-service questionnaire. |
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
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Perceived stress linked with eco-driving assistance system generated report
Časové okno: From enrollment in the study to at least 5 days and until the endpoint is reached but for a maximum duration of 14 days and only when allocated to the intervention
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When allocated to the intervention (i.e. driving shifts with buses with eco-driving assistance), participants will need to read the EDA-generated report and answer few additional questions included the end-of-service questionnaire, including a visual analog scale (VAS) for the perceived stress while reading the report Scale from 0 to 100, with 0 = no stress and 100 = maximal stress |
From enrollment in the study to at least 5 days and until the endpoint is reached but for a maximum duration of 14 days and only when allocated to the intervention
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Irina Guseva Canu, Professor, Unisanté
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2024-01573
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
All data generated during this study will be shared with restrictive access. Data are considered as coded as long as the identity of the participants involved is preserved.
Časový rámec sdílení IPD
IPD will be available at the end of the project, once all the data have been collected
Kritéria přístupu pro sdílení IPD
IPD and supporting information (containing only coded data) will be stored on the secured institutional data repository (Unisanté repository).
Access will be given upon request to the principal investigator.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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