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: 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
161
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).
Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
Mulhouse, France
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.
Time frame: Up to 15 days after randomization
Score on the Richmond Agitation-Sedation Scale
Time frame: Up to 15 days after randomization
Score on the Behavior-Pain Scale
Time frame: Up to 15 days after randomization
Duration of mechanical ventilation between admission and first extubation
Time frame: Up to 15 days after randomization
Occurrence of at least one accidental extubation during the stay
Time frame: Up to 15 days after randomization
Length of stay in intensive care unit
Time frame: Up to 15 days after randomization
Cumulative duration of delirium episodes
Time frame: Up to 15 days after randomization
Time until first episode of delirium
Time frame: Up to 15 days after randomization
Duration of neuroleptic treatment
Time frame: Up to 15 days after randomization
Occurrence of a local allergic reaction
Time frame: Up to 15 days after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.