Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 10:20 AM
Study NCT ID:
NCT04934969
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Adjunctive Use of Lavender and Peppermint Essential Oils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019341', 'term': 'Aromatherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'feasibility of using essential oils post joint replacement surgery and trends toward relief of symptoms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'discomfort, anxiety, or GI distress', 'timeFrame': 'total of 90 minutes', 'description': 'visual analog sale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Joint Diseases']}, 'descriptionModule': {'briefSummary': 'This study will use passive inhalation of lavender for discomfort, anxiety and peppermint for nausea following joint replacement and spine surgery', 'detailedDescription': 'Following review of records for eligibility and consent obtained during pre op visit subjects will be enrolled in study post op they will validate desire to participate and chose to inhale (2 drops of essential oil on cotton ball in a plastic bag) lavender for discomfort or anxiety or peppermint for GI distress\n\nVisual analogue scales will be used to rate discomfort , anxiety and nausea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- elective joint replacement able to read and speak English and describe study procedures\n\nExclusion Criteria:\n\npregnancy\n\n* unable to smell, sensitivity to fragrances asthma or breathing problems have smoke or vaped in last 2 weeks if atrial fibrillation history no peppermint uncontrolled hypertension above 160/100 non employees of UH or students of CWRU'}, 'identificationModule': {'nctId': 'NCT04934969', 'acronym': 'aromatherapy', 'briefTitle': 'The Adjunctive Use of Lavender and Peppermint Essential Oils', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'The Adjunctive Use of Lavender and Peppermint Essential Oils to Manage Nausea, Pain, and Anxiety in an Adult Orthopedic Population', 'orgStudyIdInfo': {'id': '20190050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of lavender and peppermint essential oils pre and post', 'description': 'passive inhalation of either peppermint and lavender essential oil with pre and post test measure', 'interventionNames': ['Dietary Supplement: Adjunctive use of lavender and peppermint essential oils']}], 'interventions': [{'name': 'Adjunctive use of lavender and peppermint essential oils', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['aromatherapy'], 'description': 'passive inhalation aromatherapy following joint surgery', 'armGroupLabels': ['Use of lavender and peppermint essential oils pre and post']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Denise Kresevic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'hope to publish results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical nurse specialist', 'investigatorFullName': 'Denise Kresevic', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}