Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:41 AM
Study NCT ID:
NCT07354360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oketani Breast Massage on Promoting Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* The massage will be performed very gently and rhythmically on the right and left breasts within 8 several manual steps. From one to seven refers to (the course of treatment) \\& Step eight refers to (milking or expressing).\n* One minute will be spent on a series of tasks and statements, which will be repeated for 15 to 20 minutes. Pushing and pulling away included manipulations in stages one, two, and three will be carried out gently and painlessly on primipara women in order to separate the hard section of the breast from the fascia of the pectoralis. Four to six steps will be required to drag the entire breast downward and to either side with two thumbs and two hands. At four Steps; the total breast will be pushed down towards the umbilicus. Five to six steps will be done to disconnect the hard base parts of the breast. In addition to, the breast will be circulated clockwise in the first seven steps with an expansion of its base. In the eighth step, expression will be done'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).', 'timeFrame': 'baseline; 2nd time on discharge (24 hours postpartum) and the third time post one week', 'description': 'It will be adopted by (Dennis et al., 2011) to measure breastfeeding confidence. The short form scale contains 14 statements as (I think I can always breastfeed my baby without using formula as a supplement, I think I can always keep wanting to breastfeed, ….. etc) that are scored on a 5-point Likert scale ranging from very confident (score 5) to never confident (score 1). The minimum on this scale is 14 and the maximum possible score is 70. The total scores breastfeeding self-efficacy ranged from 14 to 70 then the level of self-efficacy categorized as the following:\n\nO Low self-efficacy \\< 60% (14- 41) O Medium self-efficacy 60% to \\<75% (42 - 51) O High self-efficacy ≥ 75% (52 - 70).'}, {'measure': 'Six-point engorgement scale', 'timeFrame': 'Fourth day', 'description': 'It will be adopted from (Hill and Humenick,1994). Breast engorgement was graded on a scale of 1 to 6. Each score represented the following description: (1) soft and no changes in the breast, (2) small changes in the breast, (3) firm and no tender breast, (4) firm and beginning tenderness in the breast, (5) firm and tender of the breast, and (6) very firm and tender.\n\nScoring system:\n\nScore 1 signifies normal breast (no engorgement). Score 2 and 3 signifies mild breast engorgement. Score 4 and 5 signifies moderate breast engorgement. Score 6 signifies severe breast engorgement.'}], 'primaryOutcomes': [{'measure': 'The LATCH Assessment sheet', 'timeFrame': 'baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)', 'description': "It will be adopted from (Jensen et al, 1994) to assess primipara women's need for breastfeeding support, it is numbered from zero to ten, and getting a score of less than ten offers the women's need for more support during breastfeeding. The letters of the acronym LATCH appoint separate areas of assessment: L (Latch) for how well the infant latches onto the breast; A (Audible swallowing) refers the amount of audible swallowing noted while nursing the neonate; T (Type of nipple) for the women's nipple type; C (Comfort) for the women's level of comfort regarding the breast and nipple; and H (Hold) indicates to whether or not the women need help in positioning the infant.\n\nScoring system:\n\nThe system assigns a numerical score, 0, 1, or 2, to five key statements. LATCH score of poor (0 to 3), moderate (4 to 7), and good (8 to 10)"}], 'secondaryOutcomes': [{'measure': 'Infant Breastfeeding Assessment Tool (IBFAT).', 'timeFrame': 'baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)', 'description': 'It will be adopted from (Matthews, 1988) to assess the infant state and contains four statements as the following: (1) infant readiness to feed/reusability, (2) rooting, (3) fixing (the time needed to latch to the breast), and (4) the sucking pattern.\n\nScoring system:\n\nEach item is scored on a scale of 0-3, with minimum and maximum scores of 0 to 12, respectively. A score of 10-12 refers to completely successful breastfeeding behavior, a score of 7-9 indicates relatively successful breastfeeding behavior and a score of 0-6 suggests unsuccessful breastfeeding behavior.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breastfeeding', 'Oketani massage', 'breastfeeding self-efficacy', 'breast engorgement', 'Feeding Behavior'], 'conditions': ['Breastfeeding', 'Breastfeeding Self-Efficacy', 'Oketani Massage', 'Latching']}, 'descriptionModule': {'briefSummary': 'Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful breastfeeding. Oketani massage is a non-pharmacological, cost-effective breast massage technique developed to enhance milk flow, improve maternal comfort during breastfeeding and reduce breast engorgement. This study aims to evaluate effect of Oketani massage on successful breastfeeding. Successful breastfeeding will be assessed through indicators of maternal latching technique, successful breastfeeding behavior and maternal breastfeeding self-efficacy. The findings of this study may support the use of Oketani massage as a supportive nursing intervention to promote successful breastfeeding outcomes in the early postpartum period'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria:\n\n1. Age between 18 and 35 years\n2. Singleton pregnancy\n3. Term gestation (\\>37-40 weeks).\n4. Women willing to breast feed\n5. The woman will deliver by cesarean section and has relative with her\n6. Absence of maternal physical and/ or mental illness that prevents breastfeeding.\n\nThe exclusion criteria include:\n\n1. Women with breast problems such as breast tumors, breast surgery and nipple problems\n2. Women have obstetric complications as postpartum hemorrhage.\n3. Neonatal problems'}, 'identificationModule': {'nctId': 'NCT07354360', 'acronym': 'OKETANI-BF', 'briefTitle': 'Effect of Oketani Breast Massage on Promoting Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Oketani Massage on Successful Breastfeeding', 'orgStudyIdInfo': {'id': 'NURS-MU-OKETANI-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention group', 'description': 'This group will receive the Oketani massage.', 'interventionNames': ['Other: Oketani massage group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Primipara women in the control group who meet the inclusion criteria will be informed about the study and their consent will be obtained. This group will receive postpartum routine breast care according to health care facility policy. and they will be assessed according to outcome measures in the study'}], 'interventions': [{'name': 'Oketani massage group', 'type': 'OTHER', 'description': 'primipara who meet inclusion criteria and who are assigned to the intervention group will be informed about the study and their consent will be obtained.. Primipara mothers in the intervention group will receive Oketani massage after delivery to enhance successful breastfeeding. The massage is performed using 8 specific hand steps (7 steps for separating the mammary glands and 1 step for expression). Each session lasts 15-20 minutes and is repeated according to the study protocol. the researcher will train primipara relatives to apply Oketani massage after discharge to primipara after discharge. The massage aims to increase milk flow, reduce breast engorgement, improve breast softness, enhance nipple elasticity, and increase maternal comfort and breastfeeding self-efficacy.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '335516', 'city': 'Al Mansurah', 'country': 'Egypt', 'contacts': [{'name': "Nourhan Magdy Nasr, MSc in woman's health and midw", 'role': 'CONTACT', 'email': 'docnourhan74@gmail.com', 'phone': '01097316731'}], 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': "Nourhan Magdy Nasr, MSc in woman's health and midw", 'role': 'CONTACT', 'email': 'docnourhan74@gmail.com', 'phone': '01097316731'}], 'overallOfficials': [{'name': 'Nasr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}