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Completed

NCT Number: NCT04529395

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

Mulhouse, France

About this study

Secondary objectives:

  • 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.
  • To determine the factors influencing the efficacy of aromatherapy.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blending of essential oils

Other

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).

Apricot vegetable oil

Other

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).

Primary outcomes

  1. Occurrence of delirium

    Time frame: Up to 15 days after randomization

    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.

Secondary outcomes

  1. Score on the Richmond Agitation-Sedation Scale

    Time frame: Up to 15 days after randomization

  2. Score on the Behavior-Pain Scale

    Time frame: Up to 15 days after randomization

  3. Duration of mechanical ventilation between admission and first extubation

    Time frame: Up to 15 days after randomization

  4. Occurrence of at least one accidental extubation during the stay

    Time frame: Up to 15 days after randomization

  5. Length of stay in intensive care unit

    Time frame: Up to 15 days after randomization

  6. Cumulative duration of delirium episodes

    Time frame: Up to 15 days after randomization

  7. Time until first episode of delirium

    Time frame: Up to 15 days after randomization

  8. Duration of neuroleptic treatment

    Time frame: Up to 15 days after randomization

  9. Occurrence of a local allergic reaction

    Time frame: Up to 15 days after randomization

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Acronym: AROMADELI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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