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Status unknownNCT05853653NewbornUpdated May 11, 2023

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

An interventional study of Using dolls in breastfeeding education in Breastfeeding Education, Newborn; Vitality and Education, sponsored by Istanbul University - Cerrahpasa. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
209
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breastfeeding Education
  • Newborn; Vitality
  • Education

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Keywords

  • Breastfeeding
  • Nutrition
  • Newborn
  • Breastfeeding education
  • Education with a material
03

In context

Breast Feeding

289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.

This study's enrollment of 209 is above the median of 97 across 228 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 694 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not knowing Turkish
  • The woman has neurological and cognitive problems
  • Hearing and vision problems in the woman
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
209 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralUsing dolls in breastfeeding education

    Using dolls in breastfeeding education

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Aysegul Simsek
    Istanbul, Zeytinburnu 34010, Turkey (Türkiye)
08

References and documents

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. PubMed 21145148 ↗
  • 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

Individual participant data

Plan to share: Yes — It can be shared with a reasonable request from the principal investigator after the study is published.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: after the study is published in a journal.

Access criteria: A reasonable request

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05853653
Collaborators
Istinye University
Responsible party
Aysegul Simsek (Assist. Prof. Dr., Istanbul University - Cerrahpasa) — Principal investigator
First posted
May 11, 2023
Start date
Oct 1, 2022
Primary completion
Apr 15, 2023
Completion
May 31, 2023 (estimated)
Last update
May 11, 2023

Study contacts

Aysegul Simsek, PhD
principal investigator · Istinye University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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