Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2026-01-20 @ 12:55 AM
Study NCT ID:
NCT07112495
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005247', 'term': 'Feeding Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed as a randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the breastfeeding self-efficacy levels of mothers.', 'timeFrame': '1 year', 'description': 'Assessed using the Breastfeeding Self-Efficacy Scale'}, {'measure': 'To evaluate maternal attachment levels.', 'timeFrame': '1 year', 'description': 'Measured with a validated maternal attachment scale'}, {'measure': 'To examine the breastfeeding status of infants during the first six months of life.', 'timeFrame': '1 year', 'description': 'Including exclusive breastfeeding, partial breastfeeding, and formula supplementation'}, {'measure': 'To monitor infant growth and development through percentile tracking during the first six months.', 'timeFrame': '1 year', 'description': 'Based on weight, height, and head circumference measurements compared with growth charts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'pain', 'burnout', 'breastfeeding'], 'conditions': ['Pregnancy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://dusunenadamdergisi.org/article/1609', 'label': 'DOI: 10.14744/DAJPNS.2023.00212'}, {'url': 'https://dusunenadamdergisi.org/article/1609', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). However, many countries are well above this rate (Betran et al., 2021). An important factor in the preference for cesarean deliveries is the fear of vaginal delivery (Zhao et al., 2021). Vaginal delivery with epidural anesthesia in primiparous women is a very good opportunity to prevent the preference of cesarean deliveries due to fear of vaginal delivery. Unless contraindicated, epidural analgesia should be offered to women to alleviate the pain felt with contractions during labor (Callahan et al., 2023).\n\nRecently, women frequently prefer epidural anesthesia to avoid pain during vaginal delivery. Vaginal delivery with epidural anesthesia aims to minimize the pain of women during the trauma process and is the most effective pain method among pharmacological and nonpharmacological interventions (Antonakou, \\& Papoutsis, 2016). The reason why vaginal delivery with epidural anesthesia is not widespread enough is that women are not given enough information about epidural anesthesia (Shishido et al., 2020).', 'detailedDescription': 'Purpose: The aim of this study is to emphasize the importance of vaginal birth with epidural anesthesia in primiparous women (who will have their first birth) in order to reduce the effect of fear of vaginal birth on the choice of cesarean section and to evaluate the effect of increasing the level of knowledge about epidural anesthesia on birth preferences.\n\nObjectives:\n\nTo determine the level of fear and anxiety of women regarding childbirth.\n\nTo examine the effect of fear of vaginal birth on the preference for cesarean section.\n\nTo evaluate the effectiveness of vaginal birth with epidural anesthesia in pain management.\n\nTo determine the level of knowledge of women about epidural anesthesia.\n\nTo increase the rate of preference for vaginal birth by providing information about epidural anesthesia.\n\nTo reveal the role of widespread use of epidural anesthesia in reducing cesarean section rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'women in labor', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having a normal vaginal delivery in the delivery room,\n* 19 to 45 years old\n* To be transferred to the Puerperium service after delivery,\n* The baby's APGAR score is 7 and above\n* 37 and above weeks of gestation\n* No complications in the baby and mother due to childbirth\n* Postnatal care by the mother's side\n* Mother and baby sharing the same room after birth until discharge,\n* The mother is breastfeeding her baby,\n* Mother's voluntary participation in the study.\n\nExclusion Criteria:\n\n* Separation of mother and baby for any reason while the mother is with the baby\n* Transfer of the baby to the NICU\n* Wanting to get out of the study.\n* Being a single parent\n* Those who cannot speak and write Turkish"}, 'identificationModule': {'nctId': 'NCT07112495', 'briefTitle': 'Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Evaluation of the Effect of Vaginal Delivery With Labor Analgesia on Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level', 'orgStudyIdInfo': {'id': 'OznurT.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'pregnant women receiving epidural', 'interventionNames': ['Other: pregnant women with']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no pregnant women receiving epidural'}], 'interventions': [{'name': 'pregnant women with', 'type': 'OTHER', 'description': 'pregnant women with', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya University', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'overallOfficials': [{'name': 'Tiryaki', 'role': 'STUDY_CHAIR', 'affiliation': 'Sakarya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof', 'investigatorFullName': 'öznur tiryaki', 'investigatorAffiliation': 'Sakarya University'}}}}