Pregnant WomenNCT06844929
Impact of Podcast-Based Breastfeeding Education During Pregnancy on Breastfeeding Self-Efficacy in Pregnant Women
A study testing Podcast Group and Brochure Group in people with Pregnant Women and Breastfeeding, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Women who meet the sampling selection criteria will be introduced and informed about the study. Considering the patients who meet the research criteria and accept the study, patients will be divided into groups according to whether their barcode numbers are odd or even (1:1 ratio), provided that the number of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Breastfeeding
- What is being tested?
- Podcast Group and Brochure Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 21 Mar 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be primiparous
- To consent to participate in the research.
Who cannot join
- -Not completing any stage of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Suleyman Demirel University Health Sciences Faculty
Women who meet the sampling selection criteria will be introduced and informed about the study. Considering the patients who meet the research criteria and accept the study, patients will be divided into groups according to whether their barcode numbers are odd or even (1:1 ratio), provided that the number of individuals in the intervention and control groups is equal. It is planned to work with a total of 80 pregnant women, considering the losses. The intervention and control groups will be selected by drawing lots. The Introductory Information Form and Prenatal Breastfeeding Self-Efficacy Scale will be filled out by the women who meet the sampling selection criteria and accept to participate in the study before the application. The content of the podcast-based education to be given to the pregnant women in the intervention group will be created by the researcher and the consultant, and expert opinion will be obtained regarding the content. For the pregnant women in the control group; a brochure will be prepared for breastfeeding education and expert opinion will be obtained. The brochure prepared by the researcher and the consultant will be given to the pregnant women in the control group at the planned time. The pregnant women in the intervention group will be given a period of two weeks to complete the prepared podcast education. At the end of the two-week period, pregnant women in the intervention and control groups will be asked to fill out the Prenatal Breastfeeding Self-Efficacy Scale again.
Read the detailed description
Location of the study: The study is planned to be conducted in the Obstetrics Department of Süleyman Demirel University, Faculty of Medicine. The Department of Gynecology and Obstetrics was established in 1994 in the old faculty of medicine hospital in the city center. Over time, with its 5 outpatient clinic rooms and 38-bed capacity, it has become an important reference center in the Lakes Region and its surroundings, especially in complicated patient approaches. Süleyman Demirel University, Faculty of Medicine, Department of Gynecology and Obstetrics contributes to health services with its faculty members specialized in General Gynecology, Obstetrics, High Risk Pregnancies, Infertility, Assisted Reproductive Techniques (IVF), Gynecologic Oncology, Gynecologic Endoscopic Surgery, Urogynecology. Time of the study: The study will be conducted between April 2024 and January 2025. Research universe, sample, research group: The research universe will consist of women who voluntarily accept to participate in the study and apply to the Obstetrics and Gynecology outpatient clinic of Süleyman Demirel University Research and Practice Hospital. The criteria for inclusion in the study are as follows: • Being literate and speaking Turkish • Agreeing to participate in the research Research method and data collection tools: The data of this study will be collected with the Descriptive Characteristics Form and the Prenatal Breastfeeding Self-Efficacy Scale. Descriptive Characteristics Form: It will be developed by the researchers and will include questions about some sociodemographic data of the pregnant women and their breastfeeding experiences. The Prenatal Breastfeeding Self-Efficacy Scale was developed by Wells et al. in 2006 in order to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The scale consists of a total of 20 items (Appendix-III). The original scale has a total of 4 sub-dimensions. These are: Skills and Desires Sub-dimension: It consists of a total of 7 items. These items are items 6, 7, 8, 9, 10, 11 and 12. The lowest score that can be obtained from this subdimension is 7 and the highest score is 35. Information Acquisition Subdimension: It consists of a total of 5 items. These items are items 1, 2, 3, 5 and 17. The lowest score that can be obtained from this subdimension is 5 and the highest score is 25. Viewpoint of Surrounding People Subdimension: It consists of a total of 4 items. These items are items 13, 14, 15 and 16. The lowest score that can be obtained from this subdimension is 4 and the highest score is 20. Social Pressure Subdimension: It consists of a total of 2 items. These items are items 18 and 19. The lowest score that can be obtained from this subdimension is 2 and the highest score is 10. The validity and reliability of the scale for Turkish was made by Aydın and Pasinlioğlu in 2016 (Aydın \& Pasinlioğlu., 2018). Implementation of the Study: Women who meet the sampling selection criteria will be met and informed about the study. Considering the patients who meet the research criteria and accept the study, the patients will be divided into groups according to whether their barcode numbers are odd or even, provided that the number of individuals in the intervention and control groups is equal (1:1 ratio). It is planned to work with a total of 80 pregnant women, considering the losses. The intervention and control groups will be selected by drawing lots. The Introductory Information Form and Prenatal Breastfeeding Self-Efficacy Scale will be filled out by the women who meet the sampling selection criteria and accept to participate in the study before the application. The content of the podcast-based education to be given to the pregnant women in the intervention group will be created by the researcher and the consultant, and expert opinion will be obtained regarding the content. For the pregnant women in the control group; a brochure will be prepared for breastfeeding education and expert opinion will be obtained. The brochure prepared by the researcher and the consultant will be given to the pregnant women in the control group at the planned time. The pregnant women in the intervention group will be given a period of two weeks to complete the prepared podcast education. At the end of the two-week period, pregnant women in the intervention and control groups will be asked to fill out the Prenatal Breastfeeding Self-Efficacy Scale again.
Education Content: Benefits of breastfeeding, How breastfeeding mothers should be fed Hormones, What to consider when breastfeeding, Breastfeeding problems, Symptoms of insufficient milk, Reasons for and treatment of breast refusal,Necessary information on storing breast milk. Evaluation of Data: Data evaluation will be done in a computer environment using SPSS (Statistical Package For Social Sciences) 21.0 package program. Percentage distributions, mean, standard deviation chi-square test, t-test in dependent groups will be used in the analysis of data. Research findings will be evaluated at a 95% confidence interval and at a significance level of p<0.05.
- Conditions
- Pregnant Women, Breastfeeding
- Being tested
- Podcast Group, Brochure Group
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcast GroupOther
Providing breastfeeding education via podcast
Brochure GroupOther
Providing standard breastfeeding education using brochures
| Study group | Role | What they receive |
|---|---|---|
| Podcast Group | Experimental | Creating the content of podcast-based training Obtaining expert opinions on the content Recording podcasts at the Radio Television Application and Research Center Receives: Other: Podcast Group |
| Brochure Group | Other | Preparation of brochures for breastfeeding education Obtaining expert opinions Receives: Other: Brochure Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect of podcast-based breastfeeding education on pregnant women's Prenatal Breastfeeding Self-Efficacy Scale scores.
The differences in Prenatal Breastfeeding Self-Efficacy Scale scores between women who received podcast-based breastfeeding education and those who received brochure-based breastfeeding education will be evaluated.The total score on the Prenatal Breastfeeding Self-Efficacy Scale ranges from a minimum of 20 to a maximum of 100. Higher scores indicate greater breastfeeding self-efficacy
Measured: Before the intervention and 2 weeks after completing the podcast training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Sep 2024
- Primary completion21 Mar 2025 (estimated)
- Study completion21 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Atasever, Suleyman Demirel University
- Investigators
- İlknur Atasever, Dr., Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844929
- Sponsor's protocol ID
- BREASTFEED_PODCAST_2024
- Other IDs
- Suleyman Demirel University
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our plan aims to ensure transparent sharing of research results and accessibility to the scientific community. Individual participant data will be safeguarded in accordance with privacy standards
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suleyman Demirel University Health Sciences Faculty
- ClinicalTrials.gov ID
- NCT06844929
- Acronym / sponsor ID
- BREASTFEED_PODCAST_2024
- Conditions
- Pregnant Women, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 21 Mar 2025 (estimated)
- Study completion
- 21 Mar 2025 (estimated)
- First posted
- 25 Feb 2025 (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.
Women who meet the sampling selection criteria will be introduced and informed about the study. Considering the patients who meet the research criteria and accept the study, patients will be divided into groups according to whether their barcode numbers are odd or even (1:1 ratio), provided that the number of individuals in the intervention and control groups is equal. It is planned to work with a total of 80 pregnant women, considering the losses. The intervention and control groups will be selected by drawing lots. The Introductory Information Form and Prenatal Breastfeeding Self-Efficacy Scale will be filled out by the women who meet the sampling selection criteria and accept to participate in the study before the application. The content of the podcast-based education to be given to the pregnant women in the intervention group will be created by the researcher and the consultant, and expert opinion will be obtained regarding the content. For the pregnant women in the control group; a brochure will be prepared for breastfeeding education and expert opinion will be obtained. The brochure prepared by the researcher and the consultant will be given to the pregnant women in the control group at the planned time. The pregnant women in the intervention group will be given a period of two weeks to complete the prepared podcast education. At the end of the two-week period, pregnant women in the intervention and control groups will be asked to fill out the Prenatal Breastfeeding Self-Efficacy Scale again.
Detailed description
Location of the study: The study is planned to be conducted in the Obstetrics Department of Süleyman Demirel University, Faculty of Medicine. The Department of Gynecology and Obstetrics was established in 1994 in the old faculty of medicine hospital in the city center. Over time, with its 5 outpatient clinic rooms and 38-bed capacity, it has become an important reference center in the Lakes Region and its surroundings, especially in complicated patient approaches. Süleyman Demirel University, Faculty of Medicine, Department of Gynecology and Obstetrics contributes to health services with its faculty members specialized in General Gynecology, Obstetrics, High Risk Pregnancies, Infertility, Assisted Reproductive Techniques (IVF), Gynecologic Oncology, Gynecologic Endoscopic Surgery, Urogynecology. Time of the study: The study will be conducted between April 2024 and January 2025. Research universe, sample, research group: The research universe will consist of women who voluntarily accept to participate in the study and apply to the Obstetrics and Gynecology outpatient clinic of Süleyman Demirel University Research and Practice Hospital. The criteria for inclusion in the study are as follows: • Being literate and speaking Turkish • Agreeing to participate in the research Research method and data collection tools: The data of this study will be collected with the Descriptive Characteristics Form and the Prenatal Breastfeeding Self-Efficacy Scale. Descriptive Characteristics Form: It will be developed by the researchers and will include questions about some sociodemographic data of the pregnant women and their breastfeeding experiences. The Prenatal Breastfeeding Self-Efficacy Scale was developed by Wells et al. in 2006 in order to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The scale consists of a total of 20 items (Appendix-III). The original scale has a total of 4 sub-dimensions. These are: Skills and Desires Sub-dimension: It consists of a total of 7 items. These items are items 6, 7, 8, 9, 10, 11 and 12. The lowest score that can be obtained from this subdimension is 7 and the highest score is 35. Information Acquisition Subdimension: It consists of a total of 5 items. These items are items 1, 2, 3, 5 and 17. The lowest score that can be obtained from this subdimension is 5 and the highest score is 25. Viewpoint of Surrounding People Subdimension: It consists of a total of 4 items. These items are items 13, 14, 15 and 16. The lowest score that can be obtained from this subdimension is 4 and the highest score is 20. Social Pressure Subdimension: It consists of a total of 2 items. These items are items 18 and 19. The lowest score that can be obtained from this subdimension is 2 and the highest score is 10. The validity and reliability of the scale for Turkish was made by Aydın and Pasinlioğlu in 2016 (Aydın \& Pasinlioğlu., 2018). Implementation of the Study: Women who meet the sampling selection criteria will be met and informed about the study. Considering the patients who meet the research criteria and accept the study, the patients will be divided into groups according to whether their barcode numbers are odd or even, provided that the number of individuals in the intervention and control groups is equal (1:1 ratio). It is planned to work with a total of 80 pregnant women, considering the losses. The intervention and control groups will be selected by drawing lots. The Introductory Information Form and Prenatal Breastfeeding Self-Efficacy Scale will be filled out by the women who meet the sampling selection criteria and accept to participate in the study before the application. The content of the podcast-based education to be given to the pregnant women in the intervention group will be created by the researcher and the consultant, and expert opinion will be obtained regarding the content. For the pregnant women in the control group; a brochure will be prepared for breastfeeding education and expert opinion will be obtained. The brochure prepared by the researcher and the consultant will be given to the pregnant women in the control group at the planned time. The pregnant women in the intervention group will be given a period of two weeks to complete the prepared podcast education. At the end of the two-week period, pregnant women in the intervention and control groups will be asked to fill out the Prenatal Breastfeeding Self-Efficacy Scale again.
Education Content: Benefits of breastfeeding, How breastfeeding mothers should be fed Hormones, What to consider when breastfeeding, Breastfeeding problems, Symptoms of insufficient milk, Reasons for and treatment of breast refusal,Necessary information on storing breast milk. Evaluation of Data: Data evaluation will be done in a computer environment using SPSS (Statistical Package For Social Sciences) 21.0 package program. Percentage distributions, mean, standard deviation chi-square test, t-test in dependent groups will be used in the analysis of data. Research findings will be evaluated at a 95% confidence interval and at a significance level of p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Podcast Group | Experimental | Other: Podcast GroupCreating the content of podcast-based training Obtaining expert opinions on the content Recording podcasts at the Radio Television Application and Research Center |
| Brochure Group | Other | Other: Brochure GroupPreparation of brochures for breastfeeding education Obtaining expert opinions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Be primiparous
- To consent to participate in the research.
Key exclusion criteria (1 listed)
- -Not completing any stage of the study
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 |
|---|---|---|
| Podcast GroupProviding breastfeeding education via podcast | Other | Podcast Group |
| Brochure GroupProviding standard breastfeeding education using brochures | Other | Brochure Group |
Primary outcome
Measuring the effect of podcast-based breastfeeding education on pregnant women's Prenatal Breastfeeding Self-Efficacy Scale scores.
Time frame: Before the intervention and 2 weeks after completing the podcast training
The differences in Prenatal Breastfeeding Self-Efficacy Scale scores between women who received podcast-based breastfeeding education and those who received brochure-based breastfeeding education will be evaluated.The total score on the Prenatal Breastfeeding Self-Efficacy Scale ranges from a minimum of 20 to a maximum of 100. Higher scores indicate greater breastfeeding self-efficacy
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 25 Feb 2025.
- Individual participant dataSharing planned: No. Our plan aims to ensure transparent sharing of research results and accessibility to the scientific community. Individual participant data will be safeguarded in accordance with privacy standards
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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.
İlknur Atasever, Dr. principal investigator
Suleyman Demirel 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 Podcast Group and Brochure Group in people with Pregnant Women and Breastfeeding, run by Suleyman Demirel 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 2 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: enrolling by invitation, as of the sponsor's last update on 25 Feb 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?
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?
Measuring the effect of podcast-based breastfeeding education on pregnant women's Prenatal Breastfeeding Self-Efficacy Scale scores. (time frame: Before the intervention and 2 weeks after completing the podcast training). 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 25 Feb 2025.