Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT06338527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-23', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'The sleep quality of the patients was assessed at 8 a.m. for one week.', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleeping quality of the patients. The total score of PSQI ranged from 0-21, with higher scores indicating poor sleep quality.'}, {'measure': 'Anxiety', 'timeFrame': 'The anxiety level of the patients was assessed at 8 a.m. for one week.', 'description': 'Beck Anxiety Inventory (BAI) was used to assess the anxiety level of the patients. The scale consists of 21 entries with a total score ranging from 0 to 63, with higher total scores being associated with more severe levels of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep quality', 'Anxiety', 'Aromatherapy'], 'conditions': ['Sleep Quality', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '40653563', 'type': 'DERIVED', 'citation': 'Zhang F, Cheng L, Qin S, Wang L, Liu Y, Liu Y, Yang J, Fang S, An N, Zhang Y, Liu J. Effect of aromatherapy massage with lavender essential oil on sleep quality, pain, and mental and psychiatric disorders among breast cancer patients undergoing chemotherapy: a randomized controlled trial. Support Care Cancer. 2025 Jul 14;33(8):689. doi: 10.1007/s00520-025-09741-x.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 1) patients diagnosed with breast cancer and receiving chemotherapy; 2) suffering from sleep disorders or PSQI score greater than 5; 3) not using medications such as antidepressants and hypnotics that may affect the observation results; 4) age older than 18 years and volunteered to participate in this study.\n\nExclusion Criteria: 1) Asthma or severe respiratory disease; 2) Allergy to lavender; 3) Cognitive or communication disorders; 4) Breast cancer combined with severe organ dysfunction.'}, 'identificationModule': {'nctId': 'NCT06338527', 'briefTitle': 'Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Weifang Medical University'}, 'officialTitle': 'Effects of Aromatherapy on Sleep Quality and Anxiety in Patients Undergoing Chemotherapy for Breast Cancer', 'orgStudyIdInfo': {'id': '2024YX321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'The researchers placed 2 drops of lavender oil on gauze in a box each night 30 minutes before the patient went to bed and placed it 15 to 20 centimeters from the pillow.', 'interventionNames': ['Other: Aromatherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group had no aromatherapy intervention during the study period.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Aromatherapy', 'type': 'OTHER', 'description': 'Lavender oil was used for aromatherapy intervention.', 'armGroupLabels': ['Experimental group']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No aromatherapy intervention was performed during the period of the study.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '261000', 'city': 'Weifang', 'state': 'Shangdong', 'country': 'China', 'contacts': [{'name': 'Shirong Fang, M.D.', 'role': 'CONTACT', 'email': 'fsr0536@163.com'}], 'facility': "Weifang People's Hospital", 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}], 'centralContacts': [{'name': 'Jiang Liu, Researcher', 'role': 'CONTACT', 'email': 'Time1987fx@163.com', 'phone': '+8617667192336'}], 'overallOfficials': [{'name': 'Shirong Fang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Weifang People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weifang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research investigator', 'investigatorFullName': 'Jiang Liu', 'investigatorAffiliation': 'Weifang Medical University'}}}}