Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being? A Pseudo-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
- •known allergy or skin sensitivity to plasters
结局指标
主要结局
Heart rate variability (HRV)
时间窗: 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.
次要结局
- Stress biomarkers in saliva samples(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)
- Perceived stress linked with eco-driving assistance system generated report(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)
- Perceived 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)