Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)
2022年1月26日 更新者:Elisa Letellier、Hospices Civils de Lyon
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO.
In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products.
This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic.
It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD.
These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
71
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Pierre-Bénite、法国、69310
- Service d'Accueil des Urgences
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults
- Administrative and technical medical staff of the Hospices Civils de Lyon
- Contractual or holder
- Having participated in the COVER PRO study
- Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
- Affiliated with a social security system
- Having signed an informed consent
Exclusion Criteria:
- Refusal to participate
- Major under legal protection
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Follow-up
|
PCL-5 autoquestionnaire to make the PTSD diagnosis
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
大体时间:12 months after the end of the second Lockdown (December 2020)
|
: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
|
12 months after the end of the second Lockdown (December 2020)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
大体时间:9months after the end of the second Lockdown (December 2020)
|
Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
|
9months after the end of the second Lockdown (December 2020)
|
|
Anxiety evaluation at 12 months using HAD scale
大体时间:12months after the end of the second Lockdown (December 2020)
|
Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
12months after the end of the second Lockdown (December 2020)
|
|
Anxiety evaluation at 9 months using HAD scale
大体时间:9months after the end of the second Lockdown (December 2020)
|
Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
9months after the end of the second Lockdown (December 2020)
|
|
Depression evaluation at 12 months using HAD scale
大体时间:12months after the end of the second Lockdown (December 2020)
|
Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
12months after the end of the second Lockdown (December 2020)
|
|
Depression evaluation at 9 months using HAD scale
大体时间:9months after the end of the second Lockdown (December 2020)
|
Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
9months after the end of the second Lockdown (December 2020)
|
|
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
大体时间:12months after the end of the second Lockdown (December 2020)
|
Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
|
12months after the end of the second Lockdown (December 2020)
|
|
Presence of a Burn out at 9 months using the MBI scale
大体时间:9months after the end of the second Lockdown (December 2020)
|
Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
|
9months after the end of the second Lockdown (December 2020)
|
|
Work-related stress measured using Karasek questionnaire at 12 months
大体时间:12months after the end of the second Lockdown (December 2020)
|
Work-related stress measured using Karasek questionnaire at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Work-related stress measured using Karasek questionnaire at 9 months
大体时间:9months after the end of the second Lockdown (December 2020)
|
Work-related stress measured using Karasek questionnaire at 9 months
|
9months after the end of the second Lockdown (December 2020)
|
|
Consumption of psychoactive substances at 12 months
大体时间:12months after the end of the second Lockdown (December 2020)
|
Change in the consumption of psychoactive substances at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Percentage of patients with psychological Support at 12 months
大体时间:12months after the end of the second Lockdown (December 2020)
|
Percentage of patients who benefit from a psychological support at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Mean number of days of sick leave at 12 months
大体时间:12months after the end of the second Lockdown (December 2020)
|
Mean number of days of sick leave at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月12日
初级完成 (实际的)
2022年1月16日
研究完成 (实际的)
2022年1月16日
研究注册日期
首次提交
2021年9月1日
首先提交符合 QC 标准的
2021年9月1日
首次发布 (实际的)
2021年9月2日
研究记录更新
最后更新发布 (实际的)
2022年1月27日
上次提交的符合 QC 标准的更新
2022年1月26日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.