Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529395
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2020-08-03
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:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2019-A01978-49 | OTHER | ANSM | None |