Artificial IntelligenceNCT06569017
The Effect of Artificial Intelligence Supported and Nurse-Led Online Breastfeeding Counseling
A study testing 1) Artificial intelligence supported working group and Online breastfeeding counseling group led by a nurse in people with Artificial Intelligence and Nursing Caries, run by Kafkas University.
Trial summary
Breastfeeding is the gold standard in infant nutrition in the first 12 months of life (1). Breastfeeding self-efficacy perception is one of the most important factors affecting mothers\' breastfeeding duration and success in the postpartum period (2,3).Although AI has traditionally been the domain of powerful… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Artificial Intelligence, Nursing Caries, Breastfeeding
- What is being tested?
- 1) Artificial intelligence supported working group and Online breastfeeding counseling group led by a nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pregnant woman is willing to participate in the research,
- The pregnant woman must have an informed written voluntary consent form,
- The pregnant woman is over 18 years of age,
- The pregnant woman speaks and understands Turkish,
- Having the pregnant woman\'s first baby (primiparous),
- The pregnant woman is planning to give birth in the hospital where she came for pregnancy check-up,
Show all 10Show fewer
- The pregnant woman must have received breastfeeding training at the family health center to which she is affiliated.
- The baby does not have a disease that would prevent sucking (cleft palate, cleft lip, etc.),
- The baby is born older than the 37th week of pregnancy,
- The baby\'s birth weight is 2500 g and above, and the APGAR score is 7 and above at the 5th minute.
Who cannot join
- The pregnant woman has mental retardation that affects her ability to understand and comprehend,
- Multiple pregnancy,
- The pregnant woman has gestational disorders such as preeclampsia, eclampsia and a history of gestational diabetes,
- The pregnant woman has a diagnosed psychiatric disorder,
- The pregnant woman receives support from a private breastfeeding consultant,
- Taking the baby to the neonatal intensive care unit after birth,
Show all 12Show fewer
- The baby is born before the 37th week of pregnancy,
- Loss of communication with pregnant women who were contacted before birth, after birth,
- Pregnant women who do not use smartphones,
- Pregnant women who have an application installed on their phones but have never used the application until the birth,
- Pregnant women who were given an educational booklet but did not look at the booklet until the birth,
- Pregnant women who do not attend the 1.5-hour training or who have to leave the training halfway will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Artificial Intelligence Supported and Nurse-Led Online Breastfeeding Counseling on Mothers' Breastfeeding Competence: A Randomized Controlled Study
Breastfeeding is the gold standard in infant nutrition in the first 12 months of life (1). Breastfeeding self-efficacy perception is one of the most important factors affecting mothers\' breastfeeding duration and success in the postpartum period (2,3).Although AI has traditionally been the domain of powerful mainframes and data centers, new approaches have the capacity to put the power of AI directly into the hands of patients (4).Therefore, considering the importance of breastfeeding education and counseling, this study will determine the effect of training and use of a mobile application-supported artificial intelligence tool and nurse-led online breastfeeding counseling on mothers; breastfeeding self-efficacy perception, breastfeeding success, infant feeding attitude and postpartum depression levels. Thus, the effectiveness of the artificial intelligence tool and nurse-led breastfeeding counseling will be compared.
Read the detailed description
Breastfeeding positively affects mother-infant bonding (5). Breast milk is the healthiest food source for the nutrition and development of the newborn (6). Mortality and morbidity rates from infectious diseases are lower in breastfed babies (4). It is stated that breastfeeding provides protection against postpartum bleeding, postpartum depression, ovarian and breast cancer, heart disease and type 2 diabetes (3). The rate of exclusive breastfeeding in the first 6 months in the world is 43% (2). Although breastfeeding is a common practice in Turkey, the rate of babies exclusively breastfed is 45% in the first three months, 4-5. 6-8% to 14% per month. It was determined that it decreased to 4% per month (7).
Continuing breastfeeding effectively and breastfeeding success strengthens the bond between mother and baby (4). Breastfeeding self-efficacy is associated with positive breastfeeding outcomes (5). However, it has been determined that there is a positive relationship between breastfeeding self-efficacy and breastfeeding success (8). In a study conducted with mothers whose babies were followed in the neonatal intensive care unit, it was determined that there was a positive relationship between the mothers; breastfeeding success and breastfeeding self-efficacy (Y5).
Studies have determined that mothers; attitudes towards breastfeeding their babies have a significant impact on their baby's feeding behavior (5-7). When mothers develop a positive attitude towards infant nutrition, the time to start breastfeeding and the transition to breastfeeding and complementary feeding can be positively affected (6-8). However, mothers; attitudes towards breastfeeding are affected by the mothers; mood. In a study, it was determined that there was a relationship between the mother's mood and breastfeeding attitude (8). In a different study, it was found that there was a negative relationship between the mother's anxiety level and breastfeeding success (5). However, postpartum depression can occur in the postpartum period (4). Mothers with depressive symptoms experience more anxiety about breastfeeding their babies (8). It has been reported that mothers who are stressed and anxious about taking care of the baby also worry about breastfeeding, and the breastfeeding rate is lower in these mothers (8). While the mother's inability to breastfeed her baby may be a risk factor for depression, the mother may stop breastfeeding depending on the development of depression (6-8).
Nowadays, the use of artificial intelligence has become inevitable to improve the quality of nursing care (8-10). Chat-Generative Pre-Trained Transformer (Chat-GPT) (9), a system developed by Open AI (AI), extracts a wealth of information from a variety of online sources, including books, articles, and websites, and through human-like feedback It improves text creation abilities (7). It uses deep learning, which simulates human learning, to produce human-like answers to questions. Deep learning refers to the use of multiple layers of filters, each of which provides an output score that serves as input for the next layer (9). Providing education to health professionals, especially nurses, on health-related issues, including breastfeeding, is an important part of nurses; professional roes (9).
The aim of this study is to determine the effect of artificial intelligence-supported and nurse-led online breastfeeding counseling on mothers; breastfeeding competencies.
- Being tested
- 1) Artificial intelligence supported working group, Online breastfeeding counseling group led by a nurse
- Keywords
- artificial intelligence, nurse led, breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) Artificial intelligence supported working groupOther
Pregnant women will be a personal information form, breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa infant nutrition attitude scale and Edinburgh postpartum depression scale. Pregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones. Pregnant women will be expected to use this application actively until birth and submit their questions about breastfeeding to this artificial intelligence-supported mobile application and receive instant answers. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month.
Online breastfeeding counseling group led by a nurseOther
The forms that will be applied to pregnant women in all three groups at the first meeting will also be applied to this group. 32-37 in the nurse-led online breastfeeding counseling group. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session. Pregnant women in this group will receive only one session of breastfeeding training. These trainings, which will be given by the nurse, will be carried out online via video call via WhatsApp application. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month.
| Study group | Role | What they receive |
|---|---|---|
| 1) Artificial intelligence supported working group | Experimental | Pregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones. Receives: Other: 1) Artificial intelligence supported working group |
| 3) Observation group | No intervention | 32-37 in the observation group. A breastfeeding education booklet will be given to primiparous pregnant women at the gestational age. |
| 2)Nurse-led online breastfeeding counseling group | Experimental | 32-37. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session. Receives: Other: Online breastfeeding counseling group led by a nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
mothers' breastfeeding self-efficacy perception
Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured.
Measured: Measurements will be completed by 12 months
Secondary outcomes (1)
mothers' breastfeeding success
Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured.
Measured: Measurements will be completed by 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Turk Delibalta, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569017
- Sponsor's protocol ID
- 17993095
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Intelligence Supported and Nurse-Led Online Breastfeeding Counseling on Mothers' Breastfeeding Competence: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06569017
- Acronym / sponsor ID
- 17993095
- Keywords
- artificial intelligence, nurse led, breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 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.
Breastfeeding is the gold standard in infant nutrition in the first 12 months of life (1). Breastfeeding self-efficacy perception is one of the most important factors affecting mothers\' breastfeeding duration and success in the postpartum period (2,3).Although AI has traditionally been the domain of powerful mainframes and data centers, new approaches have the capacity to put the power of AI directly into the hands of patients (4).Therefore, considering the importance of breastfeeding education and counseling, this study will determine the effect of training and use of a mobile application-supported artificial intelligence tool and nurse-led online breastfeeding counseling on mothers; breastfeeding self-efficacy perception, breastfeeding success, infant feeding attitude and postpartum depression levels. Thus, the effectiveness of the artificial intelligence tool and nurse-led breastfeeding counseling will be compared.
Detailed description
Breastfeeding positively affects mother-infant bonding (5). Breast milk is the healthiest food source for the nutrition and development of the newborn (6). Mortality and morbidity rates from infectious diseases are lower in breastfed babies (4). It is stated that breastfeeding provides protection against postpartum bleeding, postpartum depression, ovarian and breast cancer, heart disease and type 2 diabetes (3). The rate of exclusive breastfeeding in the first 6 months in the world is 43% (2). Although breastfeeding is a common practice in Turkey, the rate of babies exclusively breastfed is 45% in the first three months, 4-5. 6-8% to 14% per month. It was determined that it decreased to 4% per month (7).
Continuing breastfeeding effectively and breastfeeding success strengthens the bond between mother and baby (4). Breastfeeding self-efficacy is associated with positive breastfeeding outcomes (5). However, it has been determined that there is a positive relationship between breastfeeding self-efficacy and breastfeeding success (8). In a study conducted with mothers whose babies were followed in the neonatal intensive care unit, it was determined that there was a positive relationship between the mothers; breastfeeding success and breastfeeding self-efficacy (Y5).
Studies have determined that mothers; attitudes towards breastfeeding their babies have a significant impact on their baby's feeding behavior (5-7). When mothers develop a positive attitude towards infant nutrition, the time to start breastfeeding and the transition to breastfeeding and complementary feeding can be positively affected (6-8). However, mothers; attitudes towards breastfeeding are affected by the mothers; mood. In a study, it was determined that there was a relationship between the mother's mood and breastfeeding attitude (8). In a different study, it was found that there was a negative relationship between the mother's anxiety level and breastfeeding success (5). However, postpartum depression can occur in the postpartum period (4). Mothers with depressive symptoms experience more anxiety about breastfeeding their babies (8). It has been reported that mothers who are stressed and anxious about taking care of the baby also worry about breastfeeding, and the breastfeeding rate is lower in these mothers (8). While the mother's inability to breastfeed her baby may be a risk factor for depression, the mother may stop breastfeeding depending on the development of depression (6-8).
Nowadays, the use of artificial intelligence has become inevitable to improve the quality of nursing care (8-10). Chat-Generative Pre-Trained Transformer (Chat-GPT) (9), a system developed by Open AI (AI), extracts a wealth of information from a variety of online sources, including books, articles, and websites, and through human-like feedback It improves text creation abilities (7). It uses deep learning, which simulates human learning, to produce human-like answers to questions. Deep learning refers to the use of multiple layers of filters, each of which provides an output score that serves as input for the next layer (9). Providing education to health professionals, especially nurses, on health-related issues, including breastfeeding, is an important part of nurses; professional roes (9).
The aim of this study is to determine the effect of artificial intelligence-supported and nurse-led online breastfeeding counseling on mothers; breastfeeding competencies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1) Artificial intelligence supported working group | Experimental | Other: 1) Artificial intelligence supported working groupPregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones. |
| 3) Observation group | No intervention | –32-37 in the observation group. A breastfeeding education booklet will be given to primiparous pregnant women at the gestational age. |
| 2)Nurse-led online breastfeeding counseling group | Experimental | Other: Online breastfeeding counseling group led by a nurse32-37. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The pregnant woman is willing to participate in the research,
- The pregnant woman must have an informed written voluntary consent form,
- The pregnant woman is over 18 years of age,
- The pregnant woman speaks and understands Turkish,
- Having the pregnant woman\'s first baby (primiparous),
Key exclusion criteria (12 listed)
- The pregnant woman has mental retardation that affects her ability to understand and comprehend,
- Multiple pregnancy,
- The pregnant woman has gestational disorders such as preeclampsia, eclampsia and a history of gestational diabetes,
- The pregnant woman has a diagnosed psychiatric disorder,
- The pregnant woman receives support from a private breastfeeding consultant,
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 |
|---|---|---|
| 1) Artificial intelligence supported working groupPregnant women will be a personal information form, breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa infant nutrition attitude scale and Edinburgh postpartum depression scale. Pregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones. Pregnant women will be expected to use this application actively until birth and submit their questions about breastfeeding to this artificial intelligence-supported mobile application and receive instant answers. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month. | Other | 1) Artificial intelligence supported working group |
| Online breastfeeding counseling group led by a nurseThe forms that will be applied to pregnant women in all three groups at the first meeting will also be applied to this group. 32-37 in the nurse-led online breastfeeding counseling group. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session. Pregnant women in this group will receive only one session of breastfeeding training. These trainings, which will be given by the nurse, will be carried out online via video call via WhatsApp application. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month. | Other | 2)Nurse-led online breastfeeding counseling group |
Primary outcome
mothers' breastfeeding self-efficacy perception
Time frame: Measurements will be completed by 12 months
Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured.
1 secondary outcome
mothers' breastfeeding success
Time frame: Measurements will be completed by 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- The effect of online breastfeeding education on breastfeeding motivationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Artificial Intelligence
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
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.
Questions about this trial
What is this clinical trial studying?
A study testing 1) Artificial intelligence supported working group and Online breastfeeding counseling group led by a nurse in people with Artificial Intelligence and Nursing Caries, run by Kafkas University.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zehra coktay (+905432035243, zehracoktay1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mothers' breastfeeding self-efficacy perception (time frame: Measurements will be completed by 12 months). 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 23 Aug 2024.