The Effect of Oketani Breast Massage on Breastfeeding

November 26, 2024 updated by: Filiz Ünal Toprak, Saglik Bilimleri Universitesi

The Effect of Oketani Breast Massage on Breastfeeding Success, Breastfeeding Self-Efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial

This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings and massage should be given starting from the prenatal period. It is important for health professionals to provide training and consultancy to women in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that correct breastfeeding behavior and self-sufficiency will be developed in mothers by using the oketani breast massage method. No study has been found in our country where this method is used. In this respect, the study is original. As a result of the study, it is thought that the use of oketani breast massage by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Locations

      • Çankırı, Turkey
        • Recruiting
        • Cankiri State Hospital
        • Contact:
          • Sakine Yılmaz, PhD

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

Yes

Description

Inclusion Criteria:

  • To volunteer to participate in the study,
  • To be over 18 years of age,
  • To be able to read and write,
  • To be able to read and understand Turkish,
  • To have no hearing, speech or visual impairments,
  • To have received breastfeeding training at a pregnancy school,
  • To be healthy in the 36th week of primiparous pregnancy.

Exclusion Criteria:

  • Obstacles to communication include having a visual, hearing or perception disorder,
  • Not being able to read or write,
  • Having a psychiatric illness,
  • Being multiparous and having a vaginal birth,
  • Having a risky pregnancy.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage Group
Pregnant women who meet the inclusion criteria assigned to the Oketani Massage group will be informed about the study and their written and verbal consent will be obtained. Pregnant women will be asked to fill out the 'Introductory Characteristics Information Form' and 'Prenatal Breastfeeding Self-Efficacy Scale Short Form' at the first meeting before the training and then they will be given breastfeeding training and massage prepared with the Oketani method. 2 weeks after the training, the researcher will apply Oketani breast massage twice before the mother enters the operating room and once before the mother's first breastfeeding in the operating room or in the ward. One day after birth, they will be asked to answer the Postpartum Breastfeeding Self-Efficacy Scale Short Form, LACTH and Visual Comparison Scale Satisfaction (VAS-S) scale.

The Oketani Method is based upon practical breastfeeding theory, but is original in its practice. Oketani breast massage improves breastmilk secretion, can prevent and treat problems such as mastitis. In addition, the massage is painless, allowing your body to relax and breathe, something very much appreciated by mothers.

The Oketani breast massage consists of massaging and milking the base of the breasts. These delicate glands are massaged as well as protected.

Other Names:
  • Oketani Massage
No Intervention: Control Group
Pregnant women who meet the inclusion criteria and who are assigned to the control group will be informed about the study and their written and verbal consent will be obtained. Pregnant women will be asked to fill out the 'Introductory Characteristics Information Form' and 'Prenatal Breastfeeding Self-Efficacy Scale Short Form' at the first meeting. One day after birth, they will be asked to answer the Postpartum Breastfeeding Self-Efficacy Scale Short Form and LACTH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form
Time Frame: 1. week, 2. week and after labor 1. day

The first form of the scale developed by Dennis and Faux was designed as 33 items, but after a second study, Dennis revised the scale and created a 14-item short form. The Turkish validity and reliability study of the scale was conducted by Aluş Tokat et al. in 2017. The scale can be administered in prenatal and postnatal periods and measures how competent women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure

(1), not very sure (2), sometimes sure (3), sure (4), very sure (5). The lowest score that can be obtained from all the evaluation scores of the scale is 14 and the highest score is 70. A low total score on the scale indicates a low perception of breastfeeding self-efficacy. In the original scale, the Cronbach's alpha reliability coefficient of the prenatal form was 0.87 and the Cronbach's alpha reliability coefficient of the postnatal form was 0.86.

1. week, 2. week and after labor 1. day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Assessment Scale - Satisfaction (VAS - S)
Time Frame: After labor 1. day
The VAS is also used to measure other components besides pain, such as satisfaction.In our study, the VAS will also be used to assess mothers' breastfeeding satisfaction levels. The Visual Assessment Scale - Satisfaction (VAS-S) is a 10 cm ruler with the expression "Not satisfied" on one end and "Very satisfied" on the other end. The mother is asked to rate her satisfaction with breastfeeding after the training from 1 to 10. High scores on the scale indicate that the satisfaction of the recipients is also high
After labor 1. day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Filiz Ünal Toprak, PhD, Saglik Bilimleri Universitesi

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 (Actual)

November 4, 2024

Primary Completion (Estimated)

May 4, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FÜT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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