Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-28 @ 3:56 PM
Study NCT ID:
NCT05948150
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Breastfeeding Pillow on Breastfeeding Self-Efficacy and Postpartum Comfort in Women Who Had Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Quantitative'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-06-24', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increasing breastfeeding self-efficacy by using a nursing pillow', 'timeFrame': '48 hours', 'description': 'Increasing breastfeeding self-efficacy in puerperant women who gave birth by using a nursing pillow'}, {'measure': 'Increasing postpartum comfort by using a nursing pillow', 'timeFrame': '48 hours', 'description': 'Increasing postpartum comfort in postpartum women who gave birth by using a nursing pillow'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breastfeeding', 'Exclusive Breast Milk', 'Patient Comfort', 'Self-efficacy'], 'conditions': ['Cesarean Section; Dehiscence', 'First Birth']}, 'descriptionModule': {'briefSummary': 'The research is a randomised controlled experimental study. It was conducted to examine the effect of breastfeeding pillow on breastfeeding self-efficacy and postnatal comfort in primiparous puerperas who gave birth by caesarean section. The answers to the questions "Is the breastfeeding pillow effective on breastfeeding self-efficacy in primiparous puerperium giving birth by caesarean section?" and "Is the breastfeeding pillow effective on comfort during breastfeeding in primiparous puerperium giving birth by caesarean section?" are investigated. The puerperas in the experimental group were allowed to use a breastfeeding pillow during breastfeeding and evaluated at 24th and 48th hours. Puerperas in the control group continued routine breastfeeding and did not use a breastfeeding pillow. They were evaluated at 24th and 48th hours.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Graduated from primary school\n* No communication problems\n* The desire to breastfeed your baby,\n* The mother and the baby do not have any health condition that may prevent breastfeeding,\n* First pregnancy,\n* Having given birth at 37\\> 37 weeks of gestation,\n* Having a baby weighing at least 2500 g,\n* Over 18 years of age,\n* Caesarean section with a single healthy baby\n\nExclusion Criteria:\n\n* having given birth more than once\n* Under 18 years of age\n* communication problems\n* unhealthy baby birth'}, 'identificationModule': {'nctId': 'NCT05948150', 'briefTitle': 'The Effect of Breastfeeding Pillow on Breastfeeding Self-Efficacy and Postpartum Comfort in Women Who Had Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect Of Breastfeedıng Pıllow On Breastfeedıng Self- Effıcacy And Postnatal Comfort In Prımıparous Postpartum Women Who Gave Bırth By Caesarean Sectıon', 'orgStudyIdInfo': {'id': 'AtaturkU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group not to use a breastfeeding pillow', 'description': 'In this arm, individuals are not provided with a breastfeeding pillow.', 'interventionNames': ['Other: not using a breastfeeding pillow']}, {'type': 'EXPERIMENTAL', 'label': 'breastfeeding pillow group', 'description': 'In this arm, breastfeeding pillows are used for individuals', 'interventionNames': ['Other: using a breastfeeding pillow']}], 'interventions': [{'name': 'using a breastfeeding pillow', 'type': 'OTHER', 'description': 'To make the breastfeeding pillow group use the breastfeeding pillow from the 8th hour in the postnatal period and to make evaluations at 24 and 48 hours', 'armGroupLabels': ['breastfeeding pillow group']}, {'name': 'not using a breastfeeding pillow', 'type': 'OTHER', 'description': 'The non-breastfeeding pillow group was evaluated at 24 and 48 hours without the use of a breastfeeding pillow', 'armGroupLabels': ['group not to use a breastfeeding pillow']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzincan', 'country': 'Turkey (Türkiye)', 'facility': 'Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}], 'overallOfficials': [{'name': 'İltifat H Dinç', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'humeyra.dinc@erzincan.edu.tr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'İltifat Hümeyra DİNÇ', 'investigatorAffiliation': 'Ataturk University'}}}}