NCT05853653

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

April 4, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

BreastfeedingNutritionNewbornBreastfeeding educationEducation with a material

Outcome Measures

Primary Outcomes (2)

  • Effective use of dolls and breastfeeding education

    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

    The effect of breastfeeding education on the level of breastfeeding self-efficacy will be obtained by analyzing the data.

    6 months

Study Arms (2)

Using dolls in breastfeeding education

EXPERIMENTAL

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

Verbal expression is used in breastfeeding education

NO INTERVENTION

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.

Interventions

Using dolls in breastfeeding education

Using dolls in breastfeeding education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aysegul Simsek

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    BACKGROUND
  • 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.

    PMID: 21145148BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Aysegul Simsek, PhD

    Istinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled quasi-experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

April 4, 2023

First Posted

May 11, 2023

Study Start

October 1, 2022

Primary Completion

April 15, 2023

Study Completion

May 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after the study is published in a journal.
Access Criteria
A reasonable request

Locations