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临床试验/NCT04491071
NCT04491071终止不适用

Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2020年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
150
试验地点
2
主要终点
Results of the Generalized Anxiety Disorder (GAD-7)

研究概览

简要总结

The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

详细描述

The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. There are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.

The COVID-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life.

There are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.

The aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. The stress will first be measured on standardized anxiety GAD-7scale but also on more parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will be recorded.

Level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. Risk factors will be looked for, by multi parametric data analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult volunteer who agreed to answer the questionnaires
  • Age ≥ 18 years old
  • Adult affiliated or having a duty to a social security scheme

排除标准

  • Children under 18 years old
  • Inability to understand information letter, consent, or to use online questionnaire

结局指标

主要结局

Results of the Generalized Anxiety Disorder (GAD-7)

时间窗: 5 Minutes

test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: * 0-4 = None * 5-9 = Mild anxiety * 10-14 = Moderate anxiety * 15-21 = Severe anxiety

次要结局

  • Results of the Post Traumatic Stress Disorder (PTSD-8)(5 minutes)
  • Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)(5 minutes)
  • Results of the Patient Health Questionnaire (PHQ-9)(5 minutes)
  • Results of the Mental Health questionnaire(5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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