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

Intensive Care Unit Delirium Clinical Trial

— AROMADELI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529395
• Other study ID #: GHR 1017
• Secondary ID: IDRCB 2019-A0197
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: September 7, 2023

Study information

• Verified date: October 2023
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Delirium

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Score on the Richmond Agitation-Sedation Scale		Up to 15 days after randomization
Secondary	Score on the Behavior-Pain Scale		Up to 15 days after randomization
Secondary	Duration of mechanical ventilation between admission and first extubation		Up to 15 days after randomization
Secondary	Occurrence of at least one accidental extubation during the stay		Up to 15 days after randomization
Secondary	Length of stay in intensive care unit		Up to 15 days after randomization
Secondary	Cumulative duration of delirium episodes		Up to 15 days after randomization
Secondary	Time until first episode of delirium		Up to 15 days after randomization
Secondary	Duration of neuroleptic treatment		Up to 15 days after randomization
Secondary	Occurrence of a local allergic reaction		Up to 15 days after randomization