Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 8:51 AM
Study NCT ID:
NCT05130957
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Clove Oil on Labor Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045783', 'term': 'Clove Oil'}], 'ancestors': [{'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two groups as experimental and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'during labor process, until the labor process is done.', 'description': 'The scale has 0-10 points. As the point increases the pain score increases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor pain', 'midwifery', 'pregnant women', 'massage'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.', 'detailedDescription': "Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Because we study with pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All of volunteer and pregnant women is 18-35 years old.\n\nExclusion Criteria:\n\n* The pregnant women has any obstetrical complications.'}, 'identificationModule': {'nctId': 'NCT05130957', 'briefTitle': 'The Effect of Clove Oil on Labor Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Effect of Massage Applied With Clove Oil on Perceived Labor Pain', 'orgStudyIdInfo': {'id': 'AnkaraCHBilkent-MH-NK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The pregnant women in the experimental group are given a massage with clove oil.', 'interventionNames': ['Other: Massage Application with clove oil']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The pregnant women in the control group are given a massage without any oil as standard midwifery care', 'interventionNames': ['Other: Massage Application without any oil']}], 'interventions': [{'name': 'Massage Application with clove oil', 'type': 'OTHER', 'description': 'The experimental group is given a massage with clove oil,', 'armGroupLabels': ['Experimental Group']}, {'name': 'Massage Application without any oil', 'type': 'OTHER', 'description': 'The control group is given a massage without any oil as a standard midwifery care.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital- Maternity Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Nükhet Kaçar, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital- Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nükhet Kaçar', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}