Clinical trial NCT04529395: Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Official title: Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Delirium
Keywords: Intensive Care Unit
Delirium
Aromatherapy
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of delirium
timeFrame: Up to 15 days after randomization
Secondary outcomes:
measure: Score on the Richmond Agitation-Sedation Scale
timeFrame: Up to 15 days after randomization
measure: Score on the Behavior-Pain Scale
timeFrame: Up to 15 days after randomization
measure: Duration of mechanical ventilation between admission and first extubation
timeFrame: Up to 15 days after randomization
measure: Occurrence of at least one accidental extubation during the stay
timeFrame: Up to 15 days after randomization
measure: Length of stay in intensive care unit
timeFrame: Up to 15 days after randomization
measure: Cumulative duration of delirium episodes
timeFrame: Up to 15 days after randomization
measure: Time until first episode of delirium
timeFrame: Up to 15 days after randomization
measure: Duration of neuroleptic treatment
timeFrame: Up to 15 days after randomization
measure: Occurrence of a local allergic reaction
timeFrame: Up to 15 days after randomization
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
Study officials:
affiliation: GHRMSA hospital
name: Khaldoun Kuteifan, MD
role: PRINCIPAL_INVESTIGATOR
References: