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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197633
Other study ID # 22-147
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date May 1, 2024

Study information

Verified date December 2023
Source Istinye University
Contact Aysegul Simsek, PhD.
Phone +905413155773
Email aysegul.artan@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 209
Est. completion date May 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Breastfeeding training baby
Verbal breastfeeding training
Other:
Verbal breastfeeding training
Verbal breastfeeding training

Locations

Country Name City State
Turkey Istinye University Istanbul Zeytinburnu

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Arça G, Isik HK (2019) The role of midwife and nurse regarding breast milk and breastfeeding Health Sciences University Nursing, 3(1): 221-228.

Bolat F, Uslu S, Bolat G, Bülbül A, Arslan S, Çelik M, Cömert S, Nuhoglu A (2011) Factors affecting breastfeeding in the first six months. Çocuk Dergisi, 11(1):5-13. doi:10.5222/j.child.2011.005

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. — View Citation

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 Matbaacilik, Ankara

Yilmaz M, Kaya NY, Çiçek H, Sahin H, Inanç 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

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding competence score increase Breastfeeding education using a doll has a positive effect on breastfeeding competence score. 9 months
Primary Infant feeding in the postnatal period Breastfeeding education has a positive effect on infant nutrition in the postnatal period. 9 months
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