Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-20 @ 6:56 PM
Study NCT ID:
NCT04529395
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2020-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of delirium', 'timeFrame': 'Up to 15 days after randomization', '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."}], 'secondaryOutcomes': [{'measure': 'Score on the Richmond Agitation-Sedation Scale', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Score on the Behavior-Pain Scale', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Duration of mechanical ventilation between admission and first extubation', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Occurrence of at least one accidental extubation during the stay', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Length of stay in intensive care unit', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Cumulative duration of delirium episodes', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Time until first episode of delirium', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Duration of neuroleptic treatment', 'timeFrame': 'Up to 15 days after randomization'}, {'measure': 'Occurrence of a local allergic reaction', 'timeFrame': 'Up to 15 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Unit', 'Delirium', 'Aromatherapy'], 'conditions': ['Intensive Care Unit Delirium']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Secondary objectives:\n\n1. To assess the efficacy of aromatherapy on :\n\n * the level of consciousness,\n * pain,\n * the duration of mechanical ventilation,\n * the occurence of an accidental extubation,\n * the length of stay in the intensive care unit,\n * the cumulative duration of delirium episodes,\n * the time until first episode of delirium,\n * the use of neuroleptics.\n2. To determine the factors influencing the efficacy of aromatherapy.\n3. To assess the safety of aromatherapy.\n\nConduct of research:\n\nAfter inclusion, patients will be randomized between the aromatherapy and control groups. Treatment will be started on the same day as randomization.\n\nAromatherapy treatment will consist of a dermal application on the feet of a mixture of essential oils.\n\nControl treatment will consist of a dermal application on the feet of apricot vegetable oil.\n\nThe 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).\n\nTreatment will continue until the patient is discharged from the intensive care unit or no later than 15 days after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours\n* Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0\n* Patient affiliated to/beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Allergy to essential and/or vegetable oils\n* Palliative sedation\n* Foot skin injury contraindicating the application of an oil\n* Moribund patient or expected death\n* History of dementia\n* Participation to a RIPH-1 study\n* Pregnant or breastfeeding woman\n* Patient under legal protection\n* Patient deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT04529395', 'acronym': 'AROMADELI', 'briefTitle': 'Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace'}, 'officialTitle': 'Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'GHRMSA 1017'}, 'secondaryIdInfos': [{'id': 'IDRCB 2019-A01978-49', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatherapy group', 'interventionNames': ['Other: Blending of essential oils']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Apricot vegetable oil']}], 'interventions': [{'name': 'Blending of essential oils', 'type': 'OTHER', '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).', 'armGroupLabels': ['Aromatherapy group']}, {'name': 'Apricot vegetable oil', 'type': 'OTHER', '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).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mulhouse', 'country': 'France', 'facility': 'Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}], 'overallOfficials': [{'name': 'Khaldoun Kuteifan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHRMSA hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}