Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-27 @ 12:07 PM
Study NCT ID:
NCT01214304
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C045718', 'term': 'lavender oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': '8 months', 'description': 'Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.'}], 'secondaryOutcomes': [{'measure': 'Anxiety Level', 'timeFrame': '8 months', 'description': 'Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colposcopy'], 'conditions': ['Colposcopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.', 'detailedDescription': 'Aromatherapy is a modality that might reduce anxiety. Women experience high levels of anxiety and negative emotional responses at all stages of cervical cancer screening. High levels of anxiety before and during colposcopy can be bad. If lavender oil aromatherapy reduces anxiety, then simple use of this modality may improve experiences during colposcopy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB\n* All women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol.\n\nExclusion Criteria:\n\n* age \\<18 years\n* pregnancy\n* breastfeeding\n* asthma\n* poor sense of smell\n* allergy to one of the essential oils\n* consumption of any analgesic\n* short-term anxiolytic (i.e. benzodiazepines) or chronic anxiolytic medications (i.e. SSRI)'}, 'identificationModule': {'nctId': 'NCT01214304', 'acronym': 'Lavender Colpo', 'briefTitle': 'Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy', 'organization': {'class': 'FED', 'fullName': "Mike O'Callaghan Military Hospital"}, 'officialTitle': 'Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'FWH20100154H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Lavender Scent', 'description': 'Patients will receive aromatherapy with a fake lavender scent (placebo) which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure.', 'interventionNames': ['Other: Lavender Scent']}, {'type': 'EXPERIMENTAL', 'label': 'Essential Lavender Oil', 'description': 'Patients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure.', 'interventionNames': ['Other: Essential Lavender Oil']}], 'interventions': [{'name': 'Essential Lavender Oil', 'type': 'OTHER', 'description': 'Aromatherapy with essential lavender oil will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The essential lavender oil and will be administered by fan diffuser.', 'armGroupLabels': ['Essential Lavender Oil']}, {'name': 'Lavender Scent', 'type': 'OTHER', 'description': 'Aromatherapy with a fake lavender scent (placebo) will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The fake lavender scent will be administered by fan diffuser.', 'armGroupLabels': ['Lavender Scent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89191', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Mike O'Callaghan Federal Medical Center", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Paul Crawford, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mike O'Callaghan Federal Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Mike O'Callaghan Military Hospital", 'class': 'FED'}, 'collaborators': [{'name': 'American Academy of Family Physicians', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}