The Effect of Oketani Breast Massage on Breastfeeding

NCT06536608 | Recruiting

• 1 other identifier: FÜT-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Feeding; Massage

Keywords

Breast Feeding; Nursing; Massage

Outcome Measures

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.

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

Secondary Outcomes (1)

• Visual Assessment Scale - Satisfaction (VAS - S)

  After labor 1. day

Study Arms (2)

Massage Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Massage OTHER

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

Massage Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women 36 weeks and over
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Cankiri State Hospital

Çankırı, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Massage

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Filiz Ünal Toprak, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Ünal Toprak, PhD

CONTACT

05077732090; filizore1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two groups with oketani massage group and control group

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 5, 2024
• Study Start: November 4, 2024
• Primary Completion: May 4, 2025
• Study Completion: May 20, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)