NCT04529395

Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intensive Care Unit Delirium

Interventions

Type	Name	Description
OTHER	Blending of essential oils	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).
OTHER	Apricot vegetable oil	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).

Timeline

• Start date: 2020-09-18
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2020-08-27
• Last updated: 2025-11-17

Locations

1 site across 1 country: France