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

NCT04529395 | Completed

• 2 other identifiers: GHRMSA 1017IDRCB 2019-A01978-49
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Delirium

Keywords

Intensive Care Unit; Delirium; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Aromatherapy group

EXPERIMENTAL

Other: Blending of essential oils

Control group

ACTIVE COMPARATOR

Other: Apricot vegetable oil

Interventions

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).

Aromatherapy group

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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

Mulhouse, France

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Khaldoun Kuteifan, MD

  GHRMSA hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 27, 2020
• Study Start: September 18, 2020
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: November 17, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)