NCT07354360

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 12, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

BreastfeedingOketani massagebreastfeeding self-efficacybreast engorgementFeeding Behavior

Outcome Measures

Primary Outcomes (1)

  • The LATCH Assessment sheet

    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 Outcomes (1)

  • Infant Breastfeeding Assessment Tool (IBFAT).

    baseline; 2nd time after the 1st six hours after birth and the third time on discharge(24 hours postpartum)

Other Outcomes (2)

  • The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).

    baseline; 2nd time on discharge (24 hours postpartum) and the third time post one week

  • Six-point engorgement scale

    Fourth day

Study Arms (2)

Intervention group

OTHER

This group will receive the Oketani massage.

Other: Oketani massage group

Control group

NO INTERVENTION

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

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.

Intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 335516, Egypt

Location

MeSH Terms

Conditions

Breast FeedingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Nasr

    Faculty of Nursing, Dakahlia Governorate, Mansoura University, Mansoura City, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan Magdy Nasr, MSc in woman's health and midw

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * 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). * 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-02

Locations