NCT04210635已完成不适用
Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- measurement of the evolution of anxiety
研究概览
简要总结
The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.
详细描述
The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).
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
- •Hospitalized in one of the departments participating in the study
- •Presenting moderate to high intensity anxiety (Digital scale ≥ 5);
排除标准
- •Having already benefited from the "ZEN cart"
- •Having taken an anxiolytic during the past 48 hours
- •Patient (s) intubated and / or sedated
- •Allergy or known intolerance to one of the essential oils used
- •Respiratory allergies, asthma, or a history of seizures
- •Unable to understand the information note (linguistic reason, or related to his medical condition)
- •Pregnant or lactating woman.
结局指标
主要结局
measurement of the evolution of anxiety
时间窗: 6 hours
The main objective of this study is to measure the evolution of the patient's anxiety between H0 (start of a "ZEN cart" session) and H6 (end of the "ZEN cart" session).
次要结局
未报告次要终点
研究者
研究点 (1)
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