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

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Completed

Conditions: Intensive Care Unit Delirium

Treatments: Other: Apricot vegetable oil; Other: Blending of essential oils

Study type: Interventional

Funder types: Other

Identifiers

NCT04529395

IDRCB 2019-A01978-49 (Other Identifier)

GHR 1017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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161 participants in 2 patient groups

Aromatherapy group

Experimental group

Treatment:

Other: Blending of essential oils

Control group

Active Comparator group

Treatment:

Other: Apricot vegetable oil