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

December 26, 2023 updated by: Istinye University

This clinical trial aimed to determine the effect of breastfeeding education using a doll during pregnancy on newborn feeding. The main questions it aims to answer are:

  1. Breastfeeding education using a doll has a positive effect on breastfeeding competence scores.
  2. Breastfeeding training using a doll has a negative effect on the breastfeeding competence score.
  3. Breastfeeding training has a positive effect on infant feeding in the postnatal period.
  4. Breastfeeding education hurts infant feeding in the postnatal period. Prenatal data collection tools will be applied as a pretest. One group will receive prenatal breastfeeding training with a doll and a written brochure. The control group will receive verbal breastfeeding education and a written brochure.

After the birth, breastfeeding will be performed. Then a posttest will be conducted using data collection tools.

The effect of applied breastfeeding education given with a doll on infant feeding and breastfeeding self-efficacy will be determined. In addition, the effectiveness of the training material will be tested.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The most important nutrient in infant nutrition has historically been and still is breast milk. Breastfeeding has many benefits for both the baby, the mother, and 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 to its former state, 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 against a new pregnancy. In addition, being free and natural, reducing maternal-infant mortality, reducing the risk of disease, providing healthy individuals to society, being fast and requiring preparation, reducing health expenditures, reducing the loss of labor force, and reducing the risk of loss of money for working mothers were the benefits to society and the country. Many practices are carried out in the world and in our country to promote breastfeeding. One of the most important of these practices is the friendly hospital practice, which informs pregnant women and their 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. This approach aims to increase breastfeeding rates. However, in the changing world order, there may be problems with the continuation of 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 objective of these practices is to ensure exclusive breastfeeding for the first 6 months, supplementary feeding from the 6th month, 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 take place and to provide training and information in these hospitals. For this reason, breastfeeding and breastfeeding education are provided by health professionals before and after delivery. It is also recommended that this education be shaped according to the needs of the woman, the content be diversified, teaching be carried out using technology, and continuity of education be ensured. Based on this information, our study was planned in a randomized controlled quasi-experimental design to determine the effect of breastfeeding education given using a doll during pregnancy on newborn feeding.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Turkey
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34010
        • Recruiting
        • Istinye University
        • Contact:
        • Sub-Investigator:
          • Fatmanur Gacal, CM
        • Sub-Investigator:
          • Afra Nur Mert, CM
        • Sub-Investigator:
          • Nargiza Muradova, CM
        • Sub-Investigator:
          • Edanur Kocaturk, CM
        • Sub-Investigator:
          • Ozge Gunel, CM
        • Sub-Investigator:
          • Buse Senyuz, CM

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
  • Older 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training group with breastfeeding baby
Device: Breastfeeding training baby
Verbal breastfeeding training
Active Comparator: Verbal breastfeeding education group
Other: Verbal breastfeeding training
Verbal breastfeeding training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding competence score increase
Time Frame: 9 months
Breastfeeding education using a doll has a positive effect on breastfeeding competence score.
9 months
Infant feeding in the postnatal period
Time Frame: 9 months
Breastfeeding education has a positive effect on infant nutrition in the postnatal period.
9 months

Collaborators and Investigators

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

Sponsor

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

  • 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
  • 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
  • Arça G, Işık HK (2019) The role of midwife and nurse regarding breast milk and breastfeeding Health Sciences University Nursing, 3(1): 221-228.
  • Samur G. (2006) Nutrition in Pregnancy and Lactation. T.C. Ministry of Health, General Directorate of Primary Health Care Services, Department of Food Safety, Nutrition Information Series. 1st Edition. Sinem Matbaacılık, Ankara

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 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The results of the study are planned to be published in an international scientific journal and presented at the congress.

After publication and presentation, the data can be shared with a reasonable request.

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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