Breastfeeding EducationNewbornNCT05853653
Amigurumi-based Breastfeeding Education Trial
A study testing Using dolls in breastfeeding education in people with Breastfeeding Education and Newborn; Vitality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education, Newborn; Vitality, Education
- What is being tested?
- Using dolls in breastfeeding education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Not knowing Turkish
- The woman has neurological and cognitive problems
- Hearing and vision problems in the woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Low-cost Amigurumi Doll-Assisted Simulation-based Breastfeeding Education Programme: A Multicentre Randomised Controlled Study
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.
- Conditions
- Breastfeeding Education, Newborn; Vitality, Education
- Being tested
- Using dolls in breastfeeding education
- Keywords
- Breastfeeding, Nutrition, Newborn, Breastfeeding education, Education with a material
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using dolls in breastfeeding educationBehavioural
Using dolls in breastfeeding education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Oct 2022
- Primary completion15 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding EducationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled quasi-experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Simsek, Istanbul University - Cerrahpasa
- Investigators
- Aysegul Simsek, PhD, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853653
- Sponsor's protocol ID
- A-Doll
- Acronym
- Newborn
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It can be shared with a reasonable request from the principal investigator after the study is published.
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 21145148Bolat 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 at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Low-cost Amigurumi Doll-Assisted Simulation-based Breastfeeding Education Programme: A Multicentre Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05853653
- Acronym / sponsor ID
- Newborn / A-Doll
- Conditions
- Breastfeeding Education, Newborn; Vitality, Education
- Keywords
- Breastfeeding, Nutrition, Newborn, Breastfeeding education, Education with a material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Using dolls in breastfeeding education | Experimental | Behavioral: Using dolls in breastfeeding educationIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not knowing Turkish
- The woman has neurological and cognitive problems
- Hearing and vision problems in the woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using dolls in breastfeeding educationUsing dolls in breastfeeding education | Behavioural | Using dolls in breastfeeding education |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BackgroundArça 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: PubMed 21145148Eksioglu 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.
- BackgroundBolat 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
- BackgroundSamur 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
- BackgroundYılmaz 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 dataSharing planned: Yes. It can be shared with a reasonable request from the principal investigator after the study is published.
Related trials for Breastfeeding Education
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Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
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Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
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The Effect of Model-based Education on Breastfeeding Self-efficacy and Success
Breastfeeding
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Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegul Simsek, PhD principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using dolls in breastfeeding education in people with Breastfeeding Education and Newborn; Vitality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective use of dolls and breastfeeding education (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853653, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.