Intensive Care Unit DeliriumAROMADELINCT04529395
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
A study testing Blending of essential oils and Apricot vegetable oil in people with Intensive Care Unit Delirium, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Delirium
- What is being tested?
- Blending of essential oils and Apricot vegetable oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnant or breastfeeding woman
- Patient under legal protection
- Patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
Mulhouse
About this study
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.
Read the detailed description
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.
- Conditions
- Intensive Care Unit Delirium
- Being tested
- Blending of essential oils, Apricot vegetable oil
- Keywords
- Intensive Care Unit, Delirium, Aromatherapy
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blending of essential oilsOther
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 oilOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy group | Experimental | Not described Receives: Other: Blending of essential oils |
| Control group | Active comparator | Not described Receives: Other: Apricot vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 days after randomization
Secondary outcomes (9)
Score on the Richmond Agitation-Sedation Scale
Measured: Up to 15 days after randomization
Score on the Behavior-Pain Scale
Measured: Up to 15 days after randomization
Duration of mechanical ventilation between admission and first extubation
Measured: Up to 15 days after randomization
Occurrence of at least one accidental extubation during the stay
Measured: Up to 15 days after randomization
Length of stay in intensive care unit
Measured: Up to 15 days after randomization
Cumulative duration of delirium episodes
Measured: Up to 15 days after randomization
Time until first episode of delirium
Measured: Up to 15 days after randomization
Duration of neuroleptic treatment
Measured: Up to 15 days after randomization
Occurrence of a local allergic reaction
Measured: Up to 15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start18 Sep 2020
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaldoun Kuteifan, MD, Principal investigator, GHRMSA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529395
- Sponsor's protocol ID
- GHRMSA 1017
- Other IDs
- IDRCB 2019-A01978-49
- Acronym
- AROMADELI
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04529395
- Acronym / sponsor ID
- AROMADELI / GHRMSA 1017
- Conditions
- Intensive Care Unit Delirium
- Keywords
- Intensive Care Unit, Delirium, Aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy group | Experimental | Other: Blending of essential oils |
| Control group | Active comparator | Other: Apricot vegetable oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blending of essential oilsThe 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). | Other | Aromatherapy group |
| Apricot vegetable oilThe 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). | Other | Control group |
Primary outcome
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.
9 secondary outcomes
Score on the Richmond Agitation-Sedation Scale
Time frame: Up to 15 days after randomization
Score on the Behavior-Pain Scale
Time frame: Up to 15 days after randomization
Duration of mechanical ventilation between admission and first extubation
Time frame: Up to 15 days after randomization
Occurrence of at least one accidental extubation during the stay
Time frame: Up to 15 days after randomization
Length of stay in intensive care unit
Time frame: Up to 15 days after randomization
Cumulative duration of delirium episodes
Time frame: Up to 15 days after randomization
Time until first episode of delirium
Time frame: Up to 15 days after randomization
Duration of neuroleptic treatment
Time frame: Up to 15 days after randomization
Occurrence of a local allergic reaction
Time frame: Up to 15 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaldoun Kuteifan, MD principal investigator
GHRMSA hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blending of essential oils and Apricot vegetable oil in people with Intensive Care Unit Delirium, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of delirium (time frame: Up to 15 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.