Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-11 @ 7:29 AM
Study NCT ID:
NCT06128759
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2023-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focusing on the Maryam's Flower During the Birth
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of labor pain by VAS', 'timeFrame': 'immediately after intervention', 'description': 'Visual Analog Scale: The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end'}, {'measure': 'Visual Similarity Scale for Fatigue', 'timeFrame': 'immediately after intervention', 'description': 'The scale consists of two subscales, fatigue and energy, and 18 items. There are 10 cm long horizontal lines with positive expressions at one end and negative expressions at the other end of the YİBGS. While the items of the fatigue subscale progress from positive to negative, the energy subscale has the opposite order. The lowest score obtained from the fatigue subscale is 0 and the highest score is 130. In the energy subscale, scores range from 0 to 50.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.\n\nMethod: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.', 'detailedDescription': 'Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years or older,\n* being in 37-42 weeks of pregnancy,\n* being primiparous,\n* having a single healthy fetus,\n* cervical dilatation not more than 3 cm.the one which,\n* in the first stage of labor,\n* Does not have any complications preventing vaginal birth,\n* volunteer women who do not have disabilities in communication and perception\n\nExclusion Criteria:\n\n* maternal and fetal complications\n* pregnant with assisted reproductive techniques,\n* having a presentation anomaly,\n* having a twin pregnancy,\n* electing cesarean section,\n* Women whose cervical dilatation exceeds 3 cm and who are not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT06128759', 'briefTitle': "Focusing on the Maryam's Flower During the Birth", 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': "The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth", 'orgStudyIdInfo': {'id': '2022/294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Maryam's Flower Group", 'description': "Maryam's flower will place in a bowl of water and left in the room of the pregnant women who will at 1 cm cervical dilatation and in the first phase of the labor. It will explain to the pregnant women that the leaves of the plant would open up in the water, and they will ask to imagine that the birth canal would simultaneously open up. In effect, they will told to focus on the opening of these leaves during the course of the labor.. After birth, the flower used only as a focusing method will be removed from the water and its water will be poured.", 'interventionNames': ["Other: Focusing on Maryam's Flower"]}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'will provided with standard midwifery care.'}], 'interventions': [{'name': "Focusing on Maryam's Flower", 'type': 'OTHER', 'otherNames': ["Foccusing on Maryam's Flower"], 'description': "Effect of Focusing on Maryam's Flower During the First Phase of the labor", 'armGroupLabels': ["Maryam's Flower Group"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Sümeyye BAL', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University'}, {'name': 'Sümeyye BAL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Sümeyye BAL', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}