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RecruitingNCT06536608Updated Nov 27, 2024

The Effect of Oketani Breast Massage on Breastfeeding

An interventional study of Massage in Breast Feeding and Massage, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Feeding
  • Massage

Keywords

  • Breast Feeding
  • Nursing
  • Massage
03

In context

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Other: 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.

Interventions

  • OtherMassage

    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.

    Also known as: Oketani Massage

06

What researchers measure

Primary outcomes

  1. Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form

    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.

    Time frame: 1. week, 2. week and after labor 1. day

Secondary outcomes

  1. Visual Assessment Scale - Satisfaction (VAS - S)

    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

    Time frame: After labor 1. day

07

Study locations

1 of 1 sites recruiting
  • Cankiri State Hospital
    Çankırı, Turkey
    • Sakine Yılmaz, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06536608
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Filiz Ünal Toprak (Associate Professor, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Aug 5, 2024
Start date
Nov 4, 2024
Primary completion
May 4, 2025 (estimated)
Completion
May 20, 2025 (estimated)
Last update
Nov 27, 2024

Study contacts

Filiz Ünal Toprak, PhD
Contact
filizore1@gmail.com
05077732090
Filiz Ünal Toprak, PhD
principal investigator · Saglik Bilimleri Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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