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Clinical Trial Summary

The primary objective of this monocenter randomized controlled trial is to assess the efficacy of aromatherapy to prevent delirium in patients hospitalized in an intensive care unit.


Clinical Trial Description

Secondary objectives: 1. To assess the efficacy of aromatherapy on : - the level of consciousness, - pain, - the duration of mechanical ventilation, - the occurence of an accidental extubation, - the length of stay in the intensive care unit, - the cumulative duration of delirium episodes, - the time until first episode of delirium, - the use of neuroleptics. 2. To determine the factors influencing the efficacy of aromatherapy. 3. To assess the safety of aromatherapy. Conduct of research: After inclusion, patients will be randomized between the aromatherapy and control groups. Treatment will be started on the same day as randomization. Aromatherapy treatment will consist of a dermal application on the feet of a mixture of essential oils. Control treatment will consist of a dermal application on the feet of apricot vegetable oil. The mixture of essential oils (aromatherapy group) or vegetable oil (control group) will be applied to the arch of the foot by massage, every eight hours, at a rate of six drops per application (3 drops per foot). Treatment will continue until the patient is discharged from the intensive care unit or no later than 15 days after randomization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04529395
Study type Interventional
Source Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Contact
Status Completed
Phase N/A
Start date September 18, 2020
Completion date September 7, 2023

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