Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Prevalence of post-traumatic stress at 1 year
研究概览
简要总结
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.
During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.
The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.
详细描述
The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.
In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.
Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.
The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients (above 18 years old)
- •Admitted in intensive care unit
- •Hospitalized more than 2 days (48 hours)
- •Between 01/01/2020 and 06/30/2020
- •Whether SARS-CoV-2 positive or negative
排除标准
- •Minor patient
- •Protected major (under safeguardship, curatorship or guardianship)
- •Patient opposition
结局指标
主要结局
Prevalence of post-traumatic stress at 1 year
时间窗: 12 months from hospitalization
Prevalence of post-traumatic stress in patients treated in intensive care at 1 year diagnosed with an IES-r\> 33 depending on whether they are SARS-CoV-2 positive or not. (IES-r: Impact of Event Scale - Revised scale, minimum value: 0, maximum value: 88, higher score indicates a worse outcome)
次要结局
- Level of depression at 1 year(12 months from hospitalization)
- Perceived interest of the proposed communication tools at 1 year(12 months from hospitalization)
- Level of quality of life at 1 year(12 months from hospitalization)