The Effect of Breastfeeding Education Using a Doll During Pregnancy on Newborn Feeding (Newborn)

May 2, 2023 updated by: Aysegul Simsek, Istanbul University - Cerrahpasa (IUC)

The Effect of Breastfeeding Education Using a Doll During Pregnancy on Newborn Feeding: A Randomized Control Trial

This study was planned in a randomized controlled quasi-experimental design to determine the effect of breastfeeding education using a doll during pregnancy on newborn feeding. Necessary institutional and ethics committee permissions will be obtained before the study. Before data collection, the consent form will be read to the pregnant women who meet the inclusion criteria and volunteer to participate in the study and their written and verbal consent will be obtained. The information in the participant information form will be questioned before the training. In the prenatal period of the study, the Control group will be given the standard breastfeeding education applied by the institution verbally. In the intervention group, breastfeeding education prepared in line with the relevant literature will be given by the researchers. Individual breastfeeding training will be given to each participant by a researcher.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The most important nutrient in infant nutrition has been breast milk throughout history. Breastfeeding has many benefits for both the infant, the mother and the society. In addition to reducing mortality and morbidity rates in infants, it provides a healthy growth and development process. It has positive effects on the mother such as feeling happy, being physically healthy with the effect of hormones, facilitating the return of the uterus, providing emotional satisfaction, reducing the risk of breast cancer, reducing the risk of anemia, reducing the risk of depression, facilitating mother-infant bonding, and protecting from a new pregnancy. In addition, being free and natural, decreasing maternal-infant mortality, decreasing the risk of disease, providing healthy individuals to the society, being fast and requiring preparation, decreasing health expenditures, decreasing the loss of labor force, decreasing the risk of loss of money for working mothers were the benefits to the society and the country. In the world and in our country, many practices are carried out to popularize breastfeeding. One of the most important of these practices is the friendly hospital practice, which informs pregnant women and families about the importance of breastfeeding. Skin-to-skin contact between mother and baby is ensured immediately after birth, and the mother is supported to start breastfeeding as soon as possible and not to interrupt contact (Bolat et al, 2011; Samur, 2006). This approach aims to increase the rate of breastfeeding. However, in the changing world order, there may be problems in maintaining the maternal herd due to the inclusion of women in business life. For this reason, practices to promote breastfeeding are on the agenda. The primary aim of these practices is to provide exclusive breastfeeding for the first 6 months, supplementary feeding from the 6th month onwards and continuation of breastfeeding until the age of 2 years. Within the scope of the "Promotion of Breastfeeding and Baby Friendly Hospitals Program" in our country, it is aimed to reach all hospitals where births are performed and to provide education and information in these hospitals. For this reason, prenatal and postnatal breastfeeding and breastfeeding education is provided by health professionals. It is also recommended that this education should be shaped according to the needs of women, the content should be diversified, teaching should be carried out by using technology, and continuity of education should be ensured.

Study Type

Interventional

Enrollment (Actual)

209

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
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34010
        • Aysegul Simsek

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:

  • Being in the last trimester of pregnancy
  • Having a healthy pregnancy
  • Fetus and newborn are healthy
  • Having the mother and baby in the same room in the postpartum period

Exclusion Criteria:

  • Not knowing Turkish
  • The woman has neurological and cognitive problems
  • Hearing and vision problems in the woman

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Using dolls in breastfeeding education
In the breastfeeding training, the researchers will explain the pre-created training content. It will then be demonstrated practically using the baby. A training brochure will be given at the end of the training.
Behavioral: Using dolls in breastfeeding education
Using dolls in breastfeeding education
No Intervention: Verbal expression is used in breastfeeding education
In the breastfeeding training, the researchers will verbally explain the pre-created training content. A training brochure will be given at the end of the training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective use of dolls and breastfeeding education
Time Frame: 6 months
The effect of breastfeeding education using dolls will be obtained by analyzing the data collected with data collection tools.
6 months
Effect of breastfeeding education on breastfeeding self-efficacy level
Time Frame: 6 months
The effect of breastfeeding education on the level of breastfeeding self-efficacy will be obtained by analyzing the data.
6 months

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Istinye University

Investigators

  • Principal Investigator: Aysegul Simsek, PhD, Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Arça G, Işık HK (2019) The role of midwife and nurse regarding breast milk and breastfeeding Health Sciences University Nursing, 2019;3(1): 221-228.
  • Eksioglu AB, Ceber E. Translation and validation of the Breast-feeding Self-efficacy Scale into Turkish. Midwifery. 2011 Dec;27(6):e246-53. doi: 10.1016/j.midw.2010.10.009. Epub 2010 Dec 8.
  • Bolat F, Uslu S, Bolat G, Bülbül A, Arslan S, Çelik M, Cömert S, Nuhoğlu A (2011) Factors affecting breastfeeding in the first six months. Çocuk Dergisi, 11(1):5-13. doi:10.5222/j.child.2011.005
  • Samur G. Nutrition in Pregnancy and Lactation. T.C. Ministry of Health, General Directorate of Primary Health Care Services, Department of Food Safety, Nutrition Information Series. 2006, 1st Edition. Sinem Matbaacılık, Ankara
  • Yılmaz M, Kaya NY, Çiçek H, Şahin H, İnanç N, Akyut M (2012) The Effect of Breastfeeding Education Given During Pregnancy on Breastfeeding and Breastfeeding Related Behaviors. Journal of Nutrition and Diet 2012;40(1):2-11

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)

October 1, 2022

Primary Completion (Actual)

April 15, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IstinyeU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It can be shared with a reasonable request from the principal investigator after the study is published.

IPD Sharing Time Frame

after the study is published in a journal.

IPD Sharing Access Criteria

A reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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