BreastfeedingMidwiferyNCT06681753
The Effect of Breastfeeding Support Education on Midwifery Profession Perception and Belonging
A study testing Experimental in people with Breastfeeding, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to provide knowledge and skills regarding breast milk and breastfeeding to midwifery students who will provide breast milk and breastfeeding consultancy to women and the society during pregnancy, birth and postpartum period after graduation, and to positively develop their professional… Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2024to 1 Jan 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 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a senior student in the SAU Faculty of Health Sciences, Midwifery Department
- The student agrees to participate in the study
Who cannot join
- The student does not agree to participate in the study
- Being a 1st, 2nd or 3rd year student in the SAU Faculty of Health Sciences, Midwifery Department
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: Associate Professor Öznur Tiryaki Sakarya University
The study was planned to provide knowledge and skills regarding breast milk and breastfeeding to midwifery students who will provide breast milk and breastfeeding consultancy to women and the society during pregnancy, birth and postpartum period after graduation, and to positively develop their professional affiliation and perception of the profession.
In this context, the following hypotheses will be tested in the study:
Read more
H0: Breastfeeding support education has no effect on the professional affiliation and perception of the profession of intern midwifery students.
H1: Breastfeeding support education increases the breastfeeding and breast milk knowledge and skills of intern midwifery students.
H2: Breastfeeding support education increases the professional affiliation of intern midwifery students.
H3: Breastfeeding support education positively develops the professional perception of intern midwifery students
Read the detailed description
The universe of the study will consist of all students studying in the Department of Midwifery at SAU Faculty of Health Sciences, and the sample will consist of senior midwifery students. In order to determine the sample size, a power analysis will be conducted using the G*Power (v3.1.7) program. The aim of the study was to evaluate the differences in the mean knowledge level scores between the groups. The effect width value was taken as 0.70 as the method used in cases where it is not known how many units of difference are significant between the groups. The effect width value of 0.20 is very high, 0.50 is at a medium level, and 0.80 gives results under the maximum acceptance limit. As the power of the study increases, it means that the measurement is more sensitive in finding the difference. The power is expected to be 0.80 and above. In the case of a Type 1 error probability (α) of 0.05 (95% confidence interval), a power level of 80%, and an effect width value of 0.70, the study will be planned with a total of 68 students, 34 students for each group. Considering the possibility of data collection forms being incomplete and empty, 10% of the sample size (37 for each group, totaling 74 students who meet the inclusion criteria) will be included in the study. When the desired number is reached for each group during the study process, the power of the study will be calculated again (post hoc).
Criteria for Inclusion in the Sample:
- Being a senior student in the SAU Faculty of Health Sciences, Midwifery Department
- The student agrees to participate in the study
Criteria for Exclusion from the Sample:
- The student does not agree to participate in the study
- Being a 1st, 2nd and 3rd year student in the SAU Faculty of Health Sciences, Midwifery Department Data Collection Tools: Data will be collected using the Demographic Information Form containing the sociodemographic characteristics of the participants, the Breast Milk and Breastfeeding Questionnaire prepared by the researchers in line with the literature, the Midwifery Belonging Scale and the Midwifery Profession Perception Scale.
- Conditions
- Breastfeeding
- Being tested
- Experimental
- Keywords
- Breast milk, Midwifery, Belonging, Profession
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Control
No training will be planned for the Control Group, and their undergraduate education will be included in the study. After the study data is collected and the study is concluded, the control group will be given breastfeeding support training from the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| the Breastfeeding Consultancy and Baby Friendly Hospital Training Program | Experimental | The project consultant (PT) who is a Breastfeeding Consultant and National Baby Friendly Hospital evaluator and a nurse working in the Neonatal Intensive Care Unit and who participated in the Breastfeeding Consultancy and Baby Friendly Hospital Training Program of the Ministry of Health, will provide 6 hours of theoretical and 2 hours of practical training on Breastfeeding and Breastfeeding support. The training content will include the following topics: Breastfeeding Status in Turkey and the World, Effective Communication and Consultancy Skills, Composition of Breast Milk, Lactation and Relaxation, Breastfeeding Positions, Feeding of Babies with Special Conditions, and Benefits of Breastfeeding. Receives: Other: Experimental |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide intern midwifery students with breastfeeding consultancy skills.
scale scores will be evaluated
Measured: 12 WEEKS
To ensure that they embrace the midwifery profession and gain a sense of belonging.
scale scores will be evaluated
Measured: 12 WEEKS
Secondary outcomes (1)
To create awareness so that they can better perceive the midwifery profession by realizing the duties, authorities and responsibilities of the profession.
scale scores will be evaluated
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pretest-posttest matched control group quasi-experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
- Investigators
- Öznur Tiryaki, PhDr, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681753
- Sponsor's protocol ID
- E-61923333-050.99-27167
- Acronym
- Midwifery
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associate Professor Öznur Tiryaki Sakarya University
- ClinicalTrials.gov ID
- NCT06681753
- Acronym / sponsor ID
- Midwifery / E-61923333-050.99-27167
- Conditions
- Breastfeeding
- Keywords
- Breast milk, Midwifery, Belonging, Profession
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Nov 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.
The study was planned to provide knowledge and skills regarding breast milk and breastfeeding to midwifery students who will provide breast milk and breastfeeding consultancy to women and the society during pregnancy, birth and postpartum period after graduation, and to positively develop their professional affiliation and perception of the profession.
In this context, the following hypotheses will be tested in the study:
H0: Breastfeeding support education has no effect on the professional affiliation and perception of the profession of intern midwifery students.
H1: Breastfeeding support education increases the breastfeeding and breast milk knowledge and skills of intern midwifery students.
H2: Breastfeeding support education increases the professional affiliation of intern midwifery students.
H3: Breastfeeding support education positively develops the professional perception of intern midwifery students
Detailed description
The universe of the study will consist of all students studying in the Department of Midwifery at SAU Faculty of Health Sciences, and the sample will consist of senior midwifery students. In order to determine the sample size, a power analysis will be conducted using the G*Power (v3.1.7) program. The aim of the study was to evaluate the differences in the mean knowledge level scores between the groups. The effect width value was taken as 0.70 as the method used in cases where it is not known how many units of difference are significant between the groups. The effect width value of 0.20 is very high, 0.50 is at a medium level, and 0.80 gives results under the maximum acceptance limit. As the power of the study increases, it means that the measurement is more sensitive in finding the difference. The power is expected to be 0.80 and above. In the case of a Type 1 error probability (α) of 0.05 (95% confidence interval), a power level of 80%, and an effect width value of 0.70, the study will be planned with a total of 68 students, 34 students for each group. Considering the possibility of data collection forms being incomplete and empty, 10% of the sample size (37 for each group, totaling 74 students who meet the inclusion criteria) will be included in the study. When the desired number is reached for each group during the study process, the power of the study will be calculated again (post hoc).
Criteria for Inclusion in the Sample:
- Being a senior student in the SAU Faculty of Health Sciences, Midwifery Department
- The student agrees to participate in the study
Criteria for Exclusion from the Sample:
- The student does not agree to participate in the study
- Being a 1st, 2nd and 3rd year student in the SAU Faculty of Health Sciences, Midwifery Department Data Collection Tools: Data will be collected using the Demographic Information Form containing the sociodemographic characteristics of the participants, the Breast Milk and Breastfeeding Questionnaire prepared by the researchers in line with the literature, the Midwifery Belonging Scale and the Midwifery Profession Perception Scale.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pretest-posttest matched control group quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| the Breastfeeding Consultancy and Baby Friendly Hospital Training Program | Experimental | Other: ExperimentalThe project consultant (PT) who is a Breastfeeding Consultant and National Baby Friendly Hospital evaluator and a nurse working in the Neonatal Intensive Care Unit and who participated in the Breastfeeding Consultancy and Baby Friendly Hospital Training Program of the Ministry of Health, will provide 6 hours of theoretical and 2 hours of practical training on Breastfeeding and Breastfeeding support. The training content will include the following topics: Breastfeeding Status in Turkey and the World, Effective Communication and Consultancy Skills, Composition of Breast Milk, Lactation and Relaxation, Breastfeeding Positions, Feeding of Babies with Special Conditions, and Benefits of Breastfeeding. |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being a senior student in the SAU Faculty of Health Sciences, Midwifery Department
- The student agrees to participate in the study
Key exclusion criteria (2 listed)
- The student does not agree to participate in the study
- Being a 1st, 2nd or 3rd year student in the SAU Faculty of Health Sciences, Midwifery Department
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 |
|---|---|---|
| ExperimentalAlso: ControlNo training will be planned for the Control Group, and their undergraduate education will be included in the study. After the study data is collected and the study is concluded, the control group will be given breastfeeding support training from the intervention group. | Other | the Breastfeeding Consultancy and Baby Friendly Hospital Training Program |
Primary outcome
To provide intern midwifery students with breastfeeding consultancy skills.
Time frame: 12 WEEKS
scale scores will be evaluated
To ensure that they embrace the midwifery profession and gain a sense of belonging.
Time frame: 12 WEEKS
scale scores will be evaluated
1 secondary outcome
To create awareness so that they can better perceive the midwifery profession by realizing the duties, authorities and responsibilities of the profession.
Time frame: 12 WEEKS
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 8 Nov 2024.
- 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.
Öznur Tiryaki, PhDr study chair
Sakarya 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 Experimental in people with Breastfeeding, run by Sakarya 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 2 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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 Öznur Tiryaki, PhDr (+902647271 ext. 7271, oznuritiryaki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide intern midwifery students with breastfeeding consultancy skills. (time frame: 12 WEEKS). 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?
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 8 Nov 2024.