PrimiparityNCT06543238
Breastfeeding Education Using the Card Game Method
A study testing Breastfeeding card game group in people with Primiparity, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of breastfeeding education using the card game method on breastfeeding success and breastfeeding self-efficacy in primiparous breastfeeding mothers. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparity
- What is being tested?
- Breastfeeding card game group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The conditions for volunteering to participate in the study are being over the age of 18, being able to read and write, being able to read and understand Turkish, not having hearing, speaking or visual impairments, having received breastfeeding training at a pregnancy school, being healthy in the 34th to 38th week of primiparous pregnancy, having a planned cesarean section, having a live birth and having a healthy baby.
Who cannot join
- Obstacles to communication include having a visual, hearing or perception disorder, not being able to read or write, having a psychiatric illness, being multiparous and having a vaginal birth, having a risky pregnancy, not having a live birth and not having a live baby after birth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakine Yılmaz
Çankırı, None Selected, 18100
Sakine Yılmaz, 05439380626, sakinee_yilmaz@hotmail.com
Sakine Yılmaz, Assist Prof
About this study
Official title: The Effect of Breastfeeding Education Using the Card Game Method on Breastfeeding Success, Breastfeeding Self-efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial
This study aims to determine the effects of breastfeeding education using the card game method on breastfeeding success and breastfeeding self-efficacy in primiparous breastfeeding mothers.
Read the detailed description
Breastfeeding is a safe feeding method that meets all nutritional and health needs of infants, strengthens immunity, protects against invisible microbes such as diarrhea and pneumonia, and improves growth, development, health and survival. Exclusive breastfeeding for 6 months and continuing breastfeeding for 2 years can improve the physical, mental and emotional health of mothers and their babies.
The World Health Organization recommends exclusive breastfeeding for up to 6 months and breastfeeding with complementary feeding until 2 years of age and beyond, as it is directly related to improving health and preventing infant morbidity and mortality. Problems that cause mothers not to breastfeed exclusively include lack of knowledge about the benefits of breastfeeding, proper breastfeeding, lack of breastfeeding consultancy services and support from health professionals, socio-cultural perceptions against breastfeeding, and lack of motivation to breastfeed.The development and implementation of effective training programs to improve breastfeeding self-efficacy is an important issue for health professionals.Therefore, the implementation of innovative strategies and methods in the field of health education can greatly contribute to women's learning in order to strengthen participation in preventive behaviors and promote breastfeeding.One of these educational methods is the card game method. Health messages are presented in various game formats such as four-card games. The educational and teaching method that uses a specific set of cards with various pictures, words and categories is a game. Card games are fun and educational games. This method has the advantages of being simple, being playable anywhere, being easy to store, being able to be played by children or adults in large or small groups and the participants being able to actively participate in the game.Nurses, who are the basic building blocks of health services, also need to provide effective care that is appropriate for the needs of the age. In this context, the educational approaches used by nurses are important. In nursing education, the use of game-based learning and teaching methods has attracted attention, especially in recent years. Game-based learning, one of the educational methods, has an important effect in increasing individuals' interest in educational subjects, ensuring the permanence of knowledge and creating motivation.It is important for health professionals to provide training and consultancy to women on this issue in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that by creating special breastfeeding cards and using a gamification-based education model, correct breastfeeding behavior and self-sufficiency will be developed in mothers. No study has been found in our country where this method has been used. In this respect, the study is original. As a result of the study, it is thought that the use of this game education model by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.
- Conditions
- Primiparity
- Being tested
- Breastfeeding card game group
- Keywords
- Primiparity, Mothers, Breast Feeding, Self Efficacy, Education, Game
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding card game groupOther
Breastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding card game | Experimental | Breastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart. Receives: Other: Breastfeeding card game group |
| Control Group | No intervention | No application will be made to this group by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale
The scale consists of a total of 14 items that evaluate breastfeeding self-efficacy. The scale is a 5-point Likert-type scale, and the items are evaluated by rating from 1 = "not sure at all" to 5 = "always sure". The lowest score that can be obtained from the scale is 14, the highest score is 70; higher scores indicate higher breastfeeding self-efficacy.
Measured: 36th week of pregnancy and postpartum
Secondary outcomes (2)
LATCH Breastfeeding Diagnostic and Assessment Scale
LATCH focuses on 5 features to be able to take appropriate action in cases where intervention is necessary for the mother. L (Latch): Baby's latching on to the breast, A (Audible Swallowing): Baby's swallowing sound is heard, T (Type of Nipple): Type of nipple, C (Comfort of Breast/Nipple): Mother's comfort with the breast/nipple H (Hold/Position): Defined as the assistance the mother needs to place her baby in the breastfeeding position. Each of the criteria is evaluated as "0, 1, 2" points. The maximum score that can be obtained is 10, and a high score from the evaluation and diagnosis scale means that breastfeeding success is high.
Measured: It will be applied to women in the control and experimental groups after birth.
Visual analog satisfaction scale
It is a scale used to evaluate satisfaction with the training provided. The individual indicates his/her satisfaction by marking a score between 0 (not satisfied at all) and 10 (very satisfied).
Measured: It will be applied to women in experimental groups after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start9 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrimiparityStudies of the same condition, open and under way.
- 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
- The study consists of two groups: control and experimental group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sakine Yılmaz, Çankırı Karatekin University
- Investigators
- Sakine Yılmaz, Principal investigator, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543238
- Sponsor's protocol ID
- CakırıKU
- Status last verified
- Feb 2025
- First submitted
- 4 Aug 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education Using the Card Game Method on Breastfeeding Success, Breastfeeding Self-efficacy and Satisfaction in Primiparous Mothers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06543238
- Acronym / sponsor ID
- CakırıKU
- Conditions
- Primiparity
- Keywords
- Primiparity, Mothers, Breast Feeding, Self Efficacy, Education, Game
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Aug 2024 (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 aims to determine the effects of breastfeeding education using the card game method on breastfeeding success and breastfeeding self-efficacy in primiparous breastfeeding mothers.
Detailed description
Breastfeeding is a safe feeding method that meets all nutritional and health needs of infants, strengthens immunity, protects against invisible microbes such as diarrhea and pneumonia, and improves growth, development, health and survival. Exclusive breastfeeding for 6 months and continuing breastfeeding for 2 years can improve the physical, mental and emotional health of mothers and their babies.
The World Health Organization recommends exclusive breastfeeding for up to 6 months and breastfeeding with complementary feeding until 2 years of age and beyond, as it is directly related to improving health and preventing infant morbidity and mortality. Problems that cause mothers not to breastfeed exclusively include lack of knowledge about the benefits of breastfeeding, proper breastfeeding, lack of breastfeeding consultancy services and support from health professionals, socio-cultural perceptions against breastfeeding, and lack of motivation to breastfeed.The development and implementation of effective training programs to improve breastfeeding self-efficacy is an important issue for health professionals.Therefore, the implementation of innovative strategies and methods in the field of health education can greatly contribute to women's learning in order to strengthen participation in preventive behaviors and promote breastfeeding.One of these educational methods is the card game method. Health messages are presented in various game formats such as four-card games. The educational and teaching method that uses a specific set of cards with various pictures, words and categories is a game. Card games are fun and educational games. This method has the advantages of being simple, being playable anywhere, being easy to store, being able to be played by children or adults in large or small groups and the participants being able to actively participate in the game.Nurses, who are the basic building blocks of health services, also need to provide effective care that is appropriate for the needs of the age. In this context, the educational approaches used by nurses are important. In nursing education, the use of game-based learning and teaching methods has attracted attention, especially in recent years. Game-based learning, one of the educational methods, has an important effect in increasing individuals' interest in educational subjects, ensuring the permanence of knowledge and creating motivation.It is important for health professionals to provide training and consultancy to women on this issue in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that by creating special breastfeeding cards and using a gamification-based education model, correct breastfeeding behavior and self-sufficiency will be developed in mothers. No study has been found in our country where this method has been used. In this respect, the study is original. As a result of the study, it is thought that the use of this game education model by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two groups: control and experimental group.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding card game | Experimental | Other: Breastfeeding card game groupBreastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart. |
| Control Group | No intervention | –No application will be made to this group by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The conditions for volunteering to participate in the study are being over the age of 18, being able to read and write, being able to read and understand Turkish, not having hearing, speaking or visual impairments, having received breastfeeding training at a pregnancy school, being healthy in the 34th to 38th week of primiparous pregnancy, having a planned cesarean section, having a live birth and having a healthy baby.
Key exclusion criteria (1 listed)
- Obstacles to communication include having a visual, hearing or perception disorder, not being able to read or write, having a psychiatric illness, being multiparous and having a vaginal birth, having a risky pregnancy, not having a live birth and not having a live baby after birth.
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 |
|---|---|---|
| Breastfeeding card game groupBreastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart. | Other | Breastfeeding card game |
Primary outcome
Breastfeeding Self-Efficacy Scale
Time frame: 36th week of pregnancy and postpartum
The scale consists of a total of 14 items that evaluate breastfeeding self-efficacy. The scale is a 5-point Likert-type scale, and the items are evaluated by rating from 1 = "not sure at all" to 5 = "always sure". The lowest score that can be obtained from the scale is 14, the highest score is 70; higher scores indicate higher breastfeeding self-efficacy.
2 secondary outcomes
LATCH Breastfeeding Diagnostic and Assessment Scale
Time frame: It will be applied to women in the control and experimental groups after birth.
Visual analog satisfaction scale
Time frame: It will be applied to women in experimental groups after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Sakine Yılmaz principal investigator
Çankırı Karatekin 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 Breastfeeding card game group in people with Primiparity, run by Çankırı Karatekin University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sakine Yılmaz (05439380626, sakinee_yilmaz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy Scale (time frame: 36th week of pregnancy and postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025.