Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT04210635
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2019-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Anxiety in Intensive Care Unit Including Olfactotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of the evolution of anxiety', 'timeFrame': '6 hours', 'description': 'The main objective of this study is to measure the evolution of the patient\'s anxiety between H0 (start of a "ZEN cart" session) and H6 (end of the "ZEN cart" session).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.', 'detailedDescription': 'The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population is made up of adult patients (aged over 18) hospitalized in the intensive care unit and expressing a complaint or presenting a state of anxiety during their hospitalization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized in one of the departments participating in the study\n* Presenting moderate to high intensity anxiety (Digital scale ≥ 5);\n\nExclusion Criteria:\n\n* Having already benefited from the "ZEN cart"\n* Having taken an anxiolytic during the past 48 hours\n* Patient (s) intubated and / or sedated\n* Allergy or known intolerance to one of the essential oils used\n* Respiratory allergies, asthma, or a history of seizures\n* Unable to understand the information note (linguistic reason, or related to his medical condition)\n* Pregnant or lactating woman.'}, 'identificationModule': {'nctId': 'NCT04210635', 'acronym': 'OCEAN', 'briefTitle': 'Management of Anxiety in Intensive Care Unit Including Olfactotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Arkopharma'}, 'officialTitle': 'Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy', 'orgStudyIdInfo': {'id': '2019- A01304-53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ZEN cart', 'type': 'OTHER', 'description': 'essential oils + relaxing music + dim light'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Laurent-du-Var', 'country': 'France', 'facility': 'Institut Arnault Tzanck', 'geoPoint': {'lat': 43.67323, 'lon': 7.19}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Arkopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}