Management of Anxiety in Intensive Care Unit Including Olfactotherapy
- Conditions
- Anxiety
- Registration Number
- NCT04210635
- Lead Sponsor
- Laboratoires Arkopharma
- Brief Summary
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.
- Detailed Description
The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Hospitalized in one of the departments participating in the study
- Presenting moderate to high intensity anxiety (Digital scale ≥ 5);
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method measurement of the evolution of anxiety 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Arnault Tzanck
🇫🇷Saint-Laurent du Var, France