Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
研究概览
简要总结
The main objective of this study is to compare the rate of reported anxiety / depression (HADS >= 8) among spouses and other family members in ICU patients.
详细描述
The secondary objectives of this study are:
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to assess symptoms of anxiety (HADS ≥ 8) and depression (HADS ≥ 8) among relatives of ICU patients three months after discharge
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to assess what relatives felt vis-à-vis the information process
-
describe the number and duration of interviews with participants
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to compare variables between the groups "spouses" and "other relatives".
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satisfaction
-
number and duration of interviews
-
HADS questionnaire
-
The scale Edmunton
-
an internal questionnaire
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IES-R score
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level of mental well-being: WEMWBS
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to describe the completeness of the study
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to test the hypothesis that the development of symptoms related to physical manifestations of anxiety and depression predicts the development of post-traumatic stress at 3 months.
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to assess the impact of the various forms of stress during hospitalization.
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
- 否
入选标准
- •The relative must have given his/her informed and signed consent
- •The relative must be insured or beneficiary of a health insurance plan
- •The relative must be available for 3 months of follow-up
排除标准
- •The relative is under judicial protection, under tutorship or curatorship
- •The relative refuses to sign the consent
- •It is impossible to correctly inform the relative
结局指标
主要结局
Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
时间窗: 3 months after the patients is discharged from the ICU unit
次要结局
- Number of interviews(During the ICU stay (days 1 to 28))
- Mean interview duration (minutes)(During the ICU stay (days 1 to 28))
- Edmonton Symptom Assessment Scale Score(4-6 days after the admission of a patient to the ICU)
- The Impact of Event Scale - Revised (IES-R)(3 months after the patients is discharged from the ICU unit)
- The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(3 months after the patients is discharged from the ICU unit)
- * Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire(4-6 days after the admission of a patient to the ICU)
- VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU(During the ICU stay (days 1 to 28))