Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03090750
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045718', 'term': 'lavender oil'}, {'id': 'C068336', 'term': 'bergamot oil'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety level of patients', 'timeFrame': 'Immediately prior to invasive radiologic procedure', 'description': 'Assessed with Amsterdam Preoperative Anxiety and Information Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Anxiety Preoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for Myelogram or IR invasive procedure at investigative site\n\nExclusion Criteria:\n\n* Incapable of giving informed consent\n* Requiring pre-medication for scheduled procedure\n* Allergy to lavender or bergamot\n* Asthma (type of breathing related condition)\n* COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)\n* Respiratory issues requiring oxygen therapy'}, 'identificationModule': {'nctId': 'NCT03090750', 'briefTitle': 'Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?', 'orgStudyIdInfo': {'id': '04-14-09B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lavender', 'description': 'Lavender oil', 'interventionNames': ['Drug: Lavender Oil']}, {'type': 'EXPERIMENTAL', 'label': 'Bergamot', 'description': 'Bergamot oil', 'interventionNames': ['Drug: Bergamot Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'Water', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'Lavender Oil', 'type': 'DRUG', 'otherNames': ['Lavender essential oil', 'Lavender', 'Lavender flower oil', 'Lavendula angustifolia'], 'description': 'Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table', 'armGroupLabels': ['Lavender']}, {'name': 'Bergamot Oil', 'type': 'DRUG', 'otherNames': ['Bergamot essential oil', 'Bergamot', 'Citrus bergamia'], 'description': 'Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table', 'armGroupLabels': ['Bergamot']}, {'name': 'Water', 'type': 'OTHER', 'description': 'Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christine A Becker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}