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Completed

NCT Number: NCT05433818

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

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Group A

Behavioral

Skin-to-Skin Contact (SSC) contributes to mother-infant interaction and can increase breastfeeding success

Other names: Skin-to-skin Contact

Group B

Other

education with a structured and expert opinion-based breastfeeding brochure

Other names: Breastfeeding education

Primary outcomes

  1. Skin-to-skin contact

    Time frame: 6-8 hours

    Positive effect of skin-to-skin contact on maternal attachment and breastfeeding efficiency

  2. 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

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Collaborators

  • Ataturk University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Feb 16, 2023

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.

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