The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment

February 14, 2023 updated by: Kutahya Health Sciences University

The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment: A Randomized Controlled Study

Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment.

Design: This study was planned as a three-group randomized controlled study. Setting and participants: This study will conduct with 92 women in a delivery room in Turkey between October 2021 and May 2022.

Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A), breastfeeding education (Group B), and control groups (Group C). Group A received SSC education and Group B received structured breastfeeding education.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primiparous women in the latent phase will given detailed information about the study (purpose and benefits of the study) and the pregnant women will invited to the study. Pregnant women will assigned to one of three groups (1:1:1) as A, B, and C in the www.randomizer.org program. Prior to the interventions, the Mother-Infant Information Form and MAI will applied to the pregnant women. After the interventions, MAI and BBAT will applied at an appropriate time when the participants felt most comfortable and rested and their perceptions will clear (4-6 hours postpartum). Eventually, the study sample will composed of 93 pregnant women based on the CONSORT 2010 (http://www.consort-statement.org/) flow diagram: 31 participants in Group A, and 31 in the Groups B, C (Figure 1).

SSC (Group-A) Pregnant women will assigned to Group A will informed about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A will also benefit from the hospital's routine breastfeeding education service.

Structured Breastfeeding Education Program (Group-B) Structured breastfeeding education material will prepared to increase breastfeeding awareness and level of knowledge. Opinions will received from 7 different experts for the education booklet and brochure. The material will revised based on expert opinions. A brochure and educational material will administered to 10 pregnant women before the study and the material will found to be understandable. The education booklet include breastfeeding techniques, the benefits of breast milk, the benefits of breastfeeding, solution suggestions for breastfeeding problems, lactation mechanism, and storage of breast milk. The breastfeeding brochure include educational texts, educators' contact information, and pictures.

Group B will receive face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered.

Control (Group-C) No intervention will made to Group C by the researchers. Participants benefite from the hospital's routine care and breastfeeding education services. Posttests will applied in a way that would not interrupt the routine care and education practices of the hospital.

Study Type

Interventional

Enrollment (Actual)

92

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 Locations

  • Turkey
      • Kütahya, Turkey, 43000
        • Kutahya Health Science University

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • were having a primiparous pregnancy,
  • being open to cooperation,
  • having a vaginal delivery,
  • giving a single mature birth,
  • having no communication problem

Exclusion Criteria:

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin-to-skin care

Pregnant women will assigned to SSC were inform about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A also benefit from the hospital's routine breastfeeding education service.

As a result, after the SSC application, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale.
Behavioral: Group A
Skin-to-Skin Contact (SSC) contributes to mother-infant interaction and can increase breastfeeding success
Other Names:
  • Skin-to-skin Contact
Active Comparator: Breastfeeding Education
Group B will received face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered. As a result, after the breastfeeding education, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale.
Other: Group B
education with a structured and expert opinion-based breastfeeding brochure
Other Names:
  • Breastfeeding education
No Intervention: Kontrol
No intervention will made to Group C by the researchers. Participants will benefit from the hospital's routine care and breastfeeding education services. As a result, postpartum mother will be evaluated with breastfeeding efficiency scale and maternal attachment scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin-to-skin contact
Time Frame: 6-8 hours
Positive effect of skin-to-skin contact on maternal attachment and breastfeeding efficiency
6-8 hours
Breastfeeding education
Time Frame: 6-8 hours
positive effect of providing education with a structured and expert opinion-based breastfeeding brochure on maternal attachment and breastfeeding efficiency
6-8 hours

Collaborators and Investigators

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

Sponsor

Kutahya Health Sciences University

Collaborators

Ataturk University

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)

January 15, 2022

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-41997688-050.99-26938

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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