- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354360
Effect of Oketani Breast Massage on Promoting Breastfeeding (OKETANI-BF)
Effect of Oketani Massage on Successful Breastfeeding
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nourhan Magdy Nasr, MSc in woman's health and midw
- Phone Number: 01097316731
- Email: docnourhan74@gmail.com
Study Locations
-
-
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Al Mansurah, Egypt, 335516
- Mansoura University
-
Contact:
- Nourhan Magdy Nasr, MSc in woman's health and midw
- Phone Number: 01097316731
- Email: docnourhan74@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
inclusion criteria:
- Age between 18 and 35 years
- Singleton pregnancy
- Term gestation (>37-40 weeks).
- Women willing to breast feed
- The woman will deliver by cesarean section and has relative with her
- Absence of maternal physical and/ or mental illness that prevents breastfeeding.
The exclusion criteria include:
- Women with breast problems such as breast tumors, breast surgery and nipple problems
- Women have obstetric complications as postpartum hemorrhage.
- Neonatal problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention group
This group will receive the Oketani massage.
|
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.
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|
No Intervention: Control group
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The LATCH Assessment sheet
Time Frame: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
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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. Scoring system: The 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) |
baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infant Breastfeeding Assessment Tool (IBFAT).
Time Frame: baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
|
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. Scoring system: Each 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. |
baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).
Time Frame: baseline; 2nd time on discharge (24 hours postpartum) and the third time post one week
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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: O Low self-efficacy < 60% (14- 41) O Medium self-efficacy 60% to <75% (42 - 51) O High self-efficacy ≥ 75% (52 - 70). |
baseline; 2nd time on discharge (24 hours postpartum) and the third time post one week
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Six-point engorgement scale
Time Frame: Fourth day
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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. Scoring system: Score 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. |
Fourth day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nasr, Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NURS-MU-OKETANI-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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