Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-03 @ 12:40 AM
Study NCT ID:
NCT06423534
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A preformatted structured questionnaire', 'timeFrame': '3 months', 'description': 'It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.'}, {'measure': 'Self-Efficacy Scale - Short-Form (BSES-SF)', 'timeFrame': '3 months', 'description': 'It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primigravida Women']}, 'descriptionModule': {'briefSummary': "Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.", 'detailedDescription': "This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.\n* Primigravida mothers during last three trimester and 1 month after delivery\n* No problems during pregnant and have a healthy baby\n* Primigravida mothers who are not contraindicated to breastfeeding\n\nExclusion Criteria:\n\n* Multigravida mothers and pregnant women during first and second trimester'}, 'identificationModule': {'nctId': 'NCT06423534', 'briefTitle': 'Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia', 'orgStudyIdInfo': {'id': 'H-2024-126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study GROUP', 'description': 'Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy', 'interventionNames': ['Behavioral: Breastfeeding Health Educational Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "The control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program", 'interventionNames': ['Behavioral: Breastfeeding Health Educational Program']}], 'interventions': [{'name': 'Breastfeeding Health Educational Program', 'type': 'BEHAVIORAL', 'description': "Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.", 'armGroupLabels': ['Control group', 'Study GROUP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hail', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Asmaa Ali', 'role': 'CONTACT', 'email': 'a.alabd@uoh.edu.sa', 'phone': '543132470'}], 'facility': 'Faculty of Nursing, Hail university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mahmoud Khedr', 'investigatorAffiliation': 'Alexandria University'}}}}