Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit (AROMADELI)
Primary Purpose
Intensive Care Unit Delirium
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blending of essential oils
Apricot vegetable oil
Sponsored by
About this trial
This is an interventional prevention trial for Intensive Care Unit Delirium focused on measuring Intensive Care Unit, Delirium, Aromatherapy
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier de Mulhouse et de la Région Sud-AlsaceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aromatherapy group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Score on the Richmond Agitation-Sedation Scale
Score on the Behavior-Pain Scale
Duration of mechanical ventilation between admission and first extubation
Occurrence of at least one accidental extubation during the stay
Length of stay in intensive care unit
Cumulative duration of delirium episodes
Time until first episode of delirium
Duration of neuroleptic treatment
Occurrence of a local allergic reaction
Full Information
NCT ID
NCT04529395
First Posted
August 3, 2020
Last Updated
September 13, 2022
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
1. Study Identification
Unique Protocol Identification Number
NCT04529395
Brief Title
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Acronym
AROMADELI
Official Title
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Delirium
Keywords
Intensive Care Unit, Delirium, Aromatherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Blending of essential oils
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Apricot vegetable oil
Intervention Description
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 Outcome Measure Information:
Title
Occurrence of delirium
Description
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.
Time Frame
Up to 15 days after randomization
Secondary Outcome Measure Information:
Title
Score on the Richmond Agitation-Sedation Scale
Time Frame
Up to 15 days after randomization
Title
Score on the Behavior-Pain Scale
Time Frame
Up to 15 days after randomization
Title
Duration of mechanical ventilation between admission and first extubation
Time Frame
Up to 15 days after randomization
Title
Occurrence of at least one accidental extubation during the stay
Time Frame
Up to 15 days after randomization
Title
Length of stay in intensive care unit
Time Frame
Up to 15 days after randomization
Title
Cumulative duration of delirium episodes
Time Frame
Up to 15 days after randomization
Title
Time until first episode of delirium
Time Frame
Up to 15 days after randomization
Title
Duration of neuroleptic treatment
Time Frame
Up to 15 days after randomization
Title
Occurrence of a local allergic reaction
Time Frame
Up to 15 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Diesel
Phone
+33 3 89 64 84 28
Email
marie.diesel@ghrmsa.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaldoun Kuteifan, MD
Organizational Affiliation
GHRMSA hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace
City
Mulhouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaldoun Kuteifan, MD
Email
KUTEIFANK@ghrmsa.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
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