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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2019-A01978-49 | Other Identifier | ANSM |
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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.
Secondary objectives:
To assess the efficacy of aromatherapy on :
To determine the factors influencing the efficacy of aromatherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatherapy group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blending of essential oils | Other | The mixture of essential oils will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of delirium | The occurrence of delirium will be defined by the presence of at least one episode during the patient's stay in the intensive care unit, diagnosed using the CAM-ICU scale. | Up to 15 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Richmond Agitation-Sedation Scale | Up to 15 days after randomization | |
| Score on the Behavior-Pain Scale | Up to 15 days after randomization | |
| Duration of mechanical ventilation between admission and first extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Kuteifan, MD | GHRMSA hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace | Mulhouse | France |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Apricot vegetable oil | Other | The apricot vegetable oil will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot). |
|
| Up to 15 days after randomization |
| Occurrence of at least one accidental extubation during the stay | Up to 15 days after randomization |
| Length of stay in intensive care unit | Up to 15 days after randomization |
| Cumulative duration of delirium episodes | Up to 15 days after randomization |
| Time until first episode of delirium | Up to 15 days after randomization |
| Duration of neuroleptic treatment | Up to 15 days after randomization |
| Occurrence of a local allergic reaction | Up to 15 days after randomization |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |