AROMADELI: Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Secondary objectives:
- To assess the efficacy of aromatherapy on :
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the level of consciousness,
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pain,
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the duration of mechanical ventilation,
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the occurence of an accidental extubation,
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the length of stay in the intensive care unit,
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the cumulative duration of delirium episodes,
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the time until first episode of delirium,
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the use of neuroleptics.
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To determine the factors influencing the efficacy of aromatherapy.
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aromatherapy group
|
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).
|
| Active Comparator: Control group
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Other: 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).
|
Outcome Measures
Primary Outcome Measures
- Occurrence of delirium [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 Outcome Measures
- 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]
- Cumulative duration of delirium episodes [Up to 15 days after randomization]
- Time until first episode of delirium [Up to 15 days after randomization]
- Duration of neuroleptic treatment [Up to 15 days after randomization]
- Occurrence of a local allergic reaction [Up to 15 days after randomization]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old
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Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours
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Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0
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Patient affiliated to/beneficiary of a social security scheme
Exclusion Criteria:
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Allergy to essential and/or vegetable oils
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Palliative sedation
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Foot skin injury contraindicating the application of an oil
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Moribund patient or expected death
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History of dementia
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Participation to a RIPH-1 study
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Pregnant or breastfeeding woman
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Patient under legal protection
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Patient deprived of liberty by judicial or administrative decision
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace | Mulhouse | France |
Sponsors and Collaborators
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
- Principal Investigator: Khaldoun Kuteifan, MD, GHRMSA hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GHR 1017
- IDRCB 2019-A01978-49