Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit (AROMADELI)

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Delirium
• Intervention / Treatment: Other: Blending of essential oils; Other: Apricot vegetable oil

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Diesel; Phone Number: +33 3 89 64 84 28; Email: marie.diesel@ghrmsa.fr

Study Locations

• France
  • Mulhouse, France
    • Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours
• Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0
• Patient affiliated to/beneficiary of a social security scheme

Exclusion Criteria:

• Allergy to essential and/or vegetable oils
• Palliative sedation
• Foot skin injury contraindicating the application of an oil
• Moribund patient or expected death
• History of dementia
• Participation to a RIPH-1 study
• Pregnant or breastfeeding woman
• Patient under legal protection
• Patient deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	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).
Experimental: Aromatherapy group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Investigators: Principal Investigator: Khaldoun Kuteifan, MD, GHRMSA hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): September 7, 2023
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Delirium; Aromatherapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: GHR 1017; IDRCB 2019-A01978-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No