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Not yet recruitingNCT06681753MidwiferyUpdated Nov 8, 2024

The Effect of Breastfeeding Support Education on Midwifery Profession Perception and Belonging

An interventional study of Experimental in Breastfeeding, sponsored by Sakarya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Sakarya University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
20 Years to 25 Years
Sex
Female
01

Study 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 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

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.
02

Conditions studied

  • Breastfeeding

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Keywords

  • Breast milk
  • Midwifery
  • Belonging
  • Profession
03

In context

Breast Feeding

289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.

This study's planned enrollment of 74 is below the median of 97 across 228 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Sakarya University is the lead sponsor of 183 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being a senior student in the SAU Faculty of Health Sciences, Midwifery Department
  • The student agrees to participate in the study

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    the Breastfeeding Consultancy and Baby Friendly Hospital Training Program

    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.

    Other: Experimental

  • No intervention
    Control

Interventions

  • OtherExperimental

    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.

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. To provide intern midwifery students with breastfeeding consultancy skills.

    scale scores will be evaluated

    Time frame: 12 WEEKS

  2. To ensure that they embrace the midwifery profession and gain a sense of belonging.

    scale scores will be evaluated

    Time frame: 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

    Time frame: 12 WEEKS

07

Study locations

1 site
  • Sakarya University
    Sakarya, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Dec 2024, 1 month later.

Of 158 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 1 month is below that.

Counting every sponsor, half of 159 studies reached it within 12 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 8, 2024
StartEst.
Nov 10, 2024
Primary completionEst.
Dec 31, 2024
CompletionEst.
Jan 1, 2025
Last update
Nov 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06681753
Lead sponsor
Sakarya University
Responsible party
öznur tiryaki (associate professor, Sakarya University) — Principal investigator
First posted
Nov 8, 2024
Start date
Nov 10, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Nov 8, 2024

Study contacts

Öznur Tiryaki, PhDr
Contact
oznuritiryaki@gmail.com
+902647271 ext. 7271
Öznur Tiryaki, PhDr
Contact
otiryaki@sakarya.edu.tr
+902647271 ext. 7271
Öznur Tiryaki, PhDr
study chair · Sakarya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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