Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06189794
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2023-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Rosa Damascena and Frankincense Essential Oils in Labor
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': 'D065260', 'term': 'Frankincense'}], 'ancestors': [{'id': 'D012116', 'term': 'Resins, Plant'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Pregnant women won't be introduced which essential oil would be used."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2023-12-16', 'studyFirstSubmitQcDate': '2023-12-31', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'labor pain', 'timeFrame': '3 hours', 'description': 'Numerical Rating Score. requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'childbirth comfort', 'timeFrame': '3 hours', 'description': 'Childbirth Comfort Questionnaire. It has 14 items to assess the comfort of the women during childbirth. The minimum score that can be obtained from the scale is 14 and the highest score is 70. Items 2,4,6,9,12,13,14 need to be reversed. As the score increases, high level comfort is indicated, and as it decreases, low level comfort is indicated.'}, {'measure': 'anxiety', 'timeFrame': '3 hours', 'description': 'Spielberger Anxiety Questionnaire. This questionnaire is a commonly used measure of trait and state anxiety. has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn\'t matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aromatherapy', 'Childbirth Problems', 'Rosa damascena', 'Frankincense', 'Comfort'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study aims to compare effects of different essential oils in labor pain, anxiety and childbirth comfort. The main questions it aims to answer are:\n\nIs it effective using rosa damascena oil during labor? Is it effective using frankincense oil during labor? Which essential oil is more effective during labor Researchers will compare aromatherapy oils groups to see labor pain, anxiety and childbirth comfort levels of pregnant women.', 'detailedDescription': 'During childbirth; pain, anxiety, and comfort level of women have a critical importance for a positive childbirth experience. So this study aims to compare the effects of different essential oils on labor pain, anxiety and labor comfort. In some studies, rosa damascena was found effective for labor pain. However, there are limited studies about comfort level and anxiety level of women during labor. So we aimed to investigate whether rosa damascena oil was effective for labor comfort and anxiety level or not. Samely it will be investigated frankincense oil was effective for labor comfort and anxiety level or not. Also which essential oil was more effective during labor will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pregnant women who are at latent phase of labor\n\nExclusion Criteria:\n\n* Complicated pregnancy (preeclampsia, hypertension, diabetes etc.)\n* Women who will have planned cesarean section\n* Asthma or any other respiratory disease\n* Allergies to Rosa Damascena or Frankincense oil'}, 'identificationModule': {'nctId': 'NCT06189794', 'briefTitle': 'Effects of Rosa Damascena and Frankincense Essential Oils in Labor', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Effects of Rosa Damascena and Frankincense Essential Oils in Labor', 'orgStudyIdInfo': {'id': '20062023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosa damascena oil group', 'description': 'Rosa Damascene oil will be used', 'interventionNames': ['Other: Rosa damascena oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Frankincense oil group', 'description': 'Frankincense oil will be used', 'interventionNames': ['Other: Rosa damascena oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Solution group', 'description': '%0.9 NaCl Isotonical Solution will be used', 'interventionNames': ['Other: Rosa damascena oil']}], 'interventions': [{'name': 'Rosa damascena oil', 'type': 'OTHER', 'otherNames': ['Frankincense oil', 'Solution group'], 'description': 'Essential oils will used by inhalation', 'armGroupLabels': ['Frankincense oil group', 'Rosa damascena oil group', 'Solution group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Balıkesir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tuba Kizilkaya, Asst.Prof.', 'role': 'CONTACT'}], 'facility': 'Balikesir University Hospital', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'centralContacts': [{'name': 'Tuba Kızılkaya, Asst.Prof.', 'role': 'CONTACT', 'email': 'kizilkaya.tb@gmail.com', 'phone': '+905514051804'}, {'name': 'Esra Cevik, Asst.Prof.', 'role': 'CONTACT', 'email': 'esracevik@outlook.com', 'phone': '+905433895090'}], 'overallOfficials': [{'name': 'Tuba Kızılkaya, Asst.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balikesir University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. PhD', 'investigatorFullName': 'Tuba Kızılkaya', 'investigatorAffiliation': 'Balikesir University'}}}}