Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07354360

Effect of Oketani Breast Massage on Promoting 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 335516, Egypt

Location contact

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

CONTACT

[email protected]

01097316731

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oketani massage group

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

01097316731

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of Oketani Massage on Successful Breastfeeding

Acronym: OKETANI-BF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.