Effect of Oketani Breast Massage on Promoting Breastfeeding (OKETANI-BF)

March 7, 2026 updated by: Mansoura University

Effect of Oketani Massage on Successful Breastfeeding

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

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nourhan Magdy Nasr, MSc in woman's health and midw
  • Phone Number: 01097316731
  • Email: docnourhan74@gmail.com

Study Locations

      • Al Mansurah, Egypt, 335516
        • Mansoura University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

inclusion criteria:

  1. Age between 18 and 35 years
  2. Singleton pregnancy
  3. Term gestation (>37-40 weeks).
  4. Women willing to breast feed
  5. The woman will deliver by cesarean section and has relative with her
  6. Absence of maternal physical and/ or mental illness that prevents breastfeeding.

The exclusion criteria include:

  1. Women with breast problems such as breast tumors, breast surgery and nipple problems
  2. Women have obstetric complications as postpartum hemorrhage.
  3. Neonatal problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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)

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

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
Six-point engorgement scale
Time Frame: Fourth day

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nasr, Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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