Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
Mulhouse, France
NCT Number: NCT04529395
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Mulhouse, France
Secondary objectives:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: Up to 15 days after randomization
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.
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Time frame: Up to 15 days after randomization
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Other
Acronym: AROMADELI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04957238
Aberrant Motor Behavior in Dementia, Agitation,Psychomotor
Aurillac, France
View Trial DetailsNCT06029244
Confusion, Critical Illness
Boston, Massachusetts, United States
View Trial DetailsNCT04182334
Anxiety, Anxiety Disorders
Avon, Indiana, United States
View Trial DetailsNCT04099472
Confusion, Critical Illness
Calgary, Alberta, Canada
View Trial Details