Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 10:33 PM
Study NCT ID:
NCT04529395
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2020-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Study Overview
Official Title:
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AROMADELI
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB 2019-A01978-49 | OTHER | ANSM | View |