Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT04529395
Brief 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.
Detailed 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:
NCT04529395
Study Brief:
Protocol Section:
NCT04529395