BreastfeedingNCT05666817
The Effect of Postpartum Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Success
A study testing breastfeeding education in people with Breastfeeding, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study will be conducted as a pre-test post-test randomized controlled study in order to determine the effect of postpartum breastfeeding education given to women who had normal vaginal delivery and cesarean section on breastfeeding self-efficacy and breastfeeding success. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- breastfeeding education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2022to 18 Dec 2022
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The following criteria will be taken into account for the individuals to be included in the intervention and control groups:
- Volunteering to participate in the research (Annex-1),
- Being between the ages of 18-40,
- Ability to read and write,
- Being able to read and understand Turkish,
- Not having a hearing, speaking or visual impairment,
- Having had a normal or cesarean delivery,
- Having a live birth and having a healthy baby.
Who cannot join
- Women under 18 years of age, • Women whose babies were taken to the neonatal intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Postpartum Breastfeeding Education Given to Women Who Had Normal Vaginal and Cesarean Delivery on Breastfeeding Self-efficacy and Breastfeeding Success
Objective: This study will be conducted as a pre-test post-test randomized controlled study in order to determine the effect of postpartum breastfeeding education given to women who had normal vaginal delivery and cesarean section on breastfeeding self-efficacy and breastfeeding success.
Materials and Methods: The data of the study were collected with "Descriptive Information Form, Breastfeeding Knowledge Level Diagnosis Form, LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale". SPSS 25.0 (Statistical Package for Social Science) program will be used in the analysis of the data.
Read more
Design: Randomized controlled.
The study included 76 women who had normal vaginal and cesarean delivery and met the inclusion criteria (Research Research group, 38 control group) in Zeynep Kamil Gynecology and Pediatrics Education and Hospital Postpartum Postpartum Postpartum Service in Istanbul.
Read the detailed description
Breast milk is a newborn-specific food that varies according to the baby's needs, body weight and the density that the baby can digest. Breastfeeding, on the other hand, is the most natural action that allows mother's milk to meet with the newborn. In addition to providing benefits for the growth and development of the baby, it contributes significantly to the maintenance of general health in advanced ages, the improvement of health and the reduction of the effect of risk factors affecting health. The concept of breastfeeding self-efficacy is the mother's perception of breastfeeding. Self-efficacy perception about breastfeeding determines the behavior of mothers to continue breastfeeding, whether they can cope with breastfeeding problems, their thoughts and attitudes about breastfeeding. Mother's age, education level, baby's weight and mother's number of births are concepts that can affect breastfeeding self-efficacy perception. Although there are many studies on breastfeeding in the literature, a limited number of studies have been found that determine the effect of the early results of postpartum breastfeeding education on breastfeeding self-efficacy and breastfeeding success.
This study aims to determine the effect of postpartum breastfeeding education given to women who had normal vaginal and cesarean delivery on breastfeeding self-efficacy and breastfeeding success.
The objectives of the research;
- To determine the effect of postpartum breastfeeding education given to women with normal vaginal delivery on breastfeeding self-efficacy.
- To determine the effect of postpartum breastfeeding education given to women who had cesarean section on breastfeeding self-efficacy.
- To determine the effect of postpartum breastfeeding education given to women who had normal vaginal delivery on breastfeeding success.
- To determine the effect of postpartum breastfeeding education given to women who had cesarean section on breastfeeding success.
- Conditions
- Breastfeeding
- Being tested
- breastfeeding education
- Keywords
- Breastfeeding, Breastfeeding Education, Self-Efficacy, Successful 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.
breastfeeding educationOther
Mothers in the intervention group will be given breastfeeding training after the pre-test application. The content of breastfeeding education is as follows;
- General information about breastfeeding,
- General information about breast milk and the benefits of breast milk,
- Benefits of breastfeeding for mother and baby,
- How the baby should be held during breastfeeding, the baby's position,
- Effective breastfeeding positions for the mother,
- Ensuring that the baby holds the breast correctly,
- Providing the correct breastfeeding technique,
- Breast milking and storage conditions,
- The necessity and benefits of continuing breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | Breastfeeding training will be given to each mother in the room she stays in the form of lectures and after the training, the question and answer method will be used. In addition, the practices explained by the researcher (the way of holding the baby, grasping the breast and positioning the baby appropriately for the baby, determining the position suitable for breastfeeding and the process of expressing and storing breast milk) will be demonstrated using the mother demonstration method in order to evaluate whether the mother understands the breastfeeding education after the breastfeeding training. Breastfeeding training will take approximately 40-45 minutes. Receives: Other: breastfeeding education |
| Control group | No intervention | No attempt will be made to the mothers in the control group following the pre-test application, within the scope of the post-test application before discharge; Breastfeeding Knowledge Level Diagnostic Form, LATCH Scale and Postnatal Self-Efficacy Scale will be applied. In addition to the breastfeeding education given to the intervention group following the post-test application to the mothers in the control group, a guide on the importance of breast milk and breastfeeding will also be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form; mother's age, education status, social security, economic status, number of pregnancies, gestational week, type of delivery, baby's gender, desire for pregnancy, how many times she applied to a health institution during her pregnancy, which health institution she applied to for control, the status of receiving breastfeeding training during pregnancy, If she received breastfeeding training, from whom she received it, the status of reading magazines/brochures about breastfeeding during pregnancy, and the status of wanting to receive free breastfeeding training after delivery.
Measured: 5 minute
Secondary outcomes (1)
Breastfeeding Knowledge Level Diagnosis Form
This form, which was prepared by the researcher in order to measure breastfeeding efficiency; It consists of 15 questions about breastfeeding initiation time, breast milk storage conditions, breastfeeding positions, breastfeeding duration and frequency, general information about breastfeeding and breast milk. Each question has three options: yes, no and I don't know. 1 point is given for each correct answer, and 0 points are given for incorrect and I don't know. The questions in the form are mixed right and wrong. If questions 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, 14, 15 are marked as correct, and questions 7, 8, and 13 as incorrect, the highest total score that can be obtained from the form will be 15.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start10 Dec 2022
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted with 76 women, 38 controls and 38 interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Bahar Kuru Aktürk, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666817
- Sponsor's protocol ID
- p8v6z463
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akturk NBK, Kolcu M. The effect of postnatal breastfeeding education given to women on breastfeeding self-efficacy and breastfeeding success. Rev Assoc Med Bras (1992). 2023 Aug 21;69(8):e20230217. doi: 10.1590/1806-9282.20230217. eCollection 2023.
PubMed 37610927
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postpartum Breastfeeding Education Given to Women Who Had Normal Vaginal and Cesarean Delivery on Breastfeeding Self-efficacy and Breastfeeding Success
- ClinicalTrials.gov ID
- NCT05666817
- Acronym / sponsor ID
- p8v6z463
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Breastfeeding Education, Self-Efficacy, Successful Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 28 Dec 2022 (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.
Objective: This study will be conducted as a pre-test post-test randomized controlled study in order to determine the effect of postpartum breastfeeding education given to women who had normal vaginal delivery and cesarean section on breastfeeding self-efficacy and breastfeeding success.
Materials and Methods: The data of the study were collected with "Descriptive Information Form, Breastfeeding Knowledge Level Diagnosis Form, LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale". SPSS 25.0 (Statistical Package for Social Science) program will be used in the analysis of the data.
Design: Randomized controlled.
The study included 76 women who had normal vaginal and cesarean delivery and met the inclusion criteria (Research Research group, 38 control group) in Zeynep Kamil Gynecology and Pediatrics Education and Hospital Postpartum Postpartum Postpartum Service in Istanbul.
Detailed description
Breast milk is a newborn-specific food that varies according to the baby's needs, body weight and the density that the baby can digest. Breastfeeding, on the other hand, is the most natural action that allows mother's milk to meet with the newborn. In addition to providing benefits for the growth and development of the baby, it contributes significantly to the maintenance of general health in advanced ages, the improvement of health and the reduction of the effect of risk factors affecting health. The concept of breastfeeding self-efficacy is the mother's perception of breastfeeding. Self-efficacy perception about breastfeeding determines the behavior of mothers to continue breastfeeding, whether they can cope with breastfeeding problems, their thoughts and attitudes about breastfeeding. Mother's age, education level, baby's weight and mother's number of births are concepts that can affect breastfeeding self-efficacy perception. Although there are many studies on breastfeeding in the literature, a limited number of studies have been found that determine the effect of the early results of postpartum breastfeeding education on breastfeeding self-efficacy and breastfeeding success.
This study aims to determine the effect of postpartum breastfeeding education given to women who had normal vaginal and cesarean delivery on breastfeeding self-efficacy and breastfeeding success.
The objectives of the research;
- To determine the effect of postpartum breastfeeding education given to women with normal vaginal delivery on breastfeeding self-efficacy.
- To determine the effect of postpartum breastfeeding education given to women who had cesarean section on breastfeeding self-efficacy.
- To determine the effect of postpartum breastfeeding education given to women who had normal vaginal delivery on breastfeeding success.
- To determine the effect of postpartum breastfeeding education given to women who had cesarean section on breastfeeding success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be conducted with 76 women, 38 controls and 38 interventions.
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: breastfeeding educationBreastfeeding training will be given to each mother in the room she stays in the form of lectures and after the training, the question and answer method will be used. In addition, the practices explained by the researcher (the way of holding the baby, grasping the breast and positioning the baby appropriately for the baby, determining the position suitable for breastfeeding and the process of expressing and storing breast milk) will be demonstrated using the mother demonstration method in order to evaluate whether the mother understands the breastfeeding education after the breastfeeding training. Breastfeeding training will take approximately 40-45 minutes. |
| Control group | No intervention | –No attempt will be made to the mothers in the control group following the pre-test application, within the scope of the post-test application before discharge; Breastfeeding Knowledge Level Diagnostic Form, LATCH Scale and Postnatal Self-Efficacy Scale will be applied. In addition to the breastfeeding education given to the intervention group following the post-test application to the mothers in the control group, a guide on the importance of breast milk and breastfeeding will also be given. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The following criteria will be taken into account for the individuals to be included in the intervention and control groups:
Key exclusion criteria (1 listed)
- Women under 18 years of age, • Women whose babies were taken to the neonatal intensive care unit.
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 educationMothers in the intervention group will be given breastfeeding training after the pre-test application. The content of breastfeeding education is as follows; * General information about breastfeeding, * General information about breast milk and the benefits of breast milk, * Benefits of breastfeeding for mother and baby, * How the baby should be held during breastfeeding, the baby's position, * Effective breastfeeding positions for the mother, * Ensuring that the baby holds the breast correctly, * Providing the correct breastfeeding technique, * Breast milking and storage conditions, * The necessity and benefits of continuing breastfeeding. | Other | experiment group |
Primary outcome
Introductory Information Form
Time frame: 5 minute
This form; mother's age, education status, social security, economic status, number of pregnancies, gestational week, type of delivery, baby's gender, desire for pregnancy, how many times she applied to a health institution during her pregnancy, which health institution she applied to for control, the status of receiving breastfeeding training during pregnancy, If she received breastfeeding training, from whom she received it, the status of reading magazines/brochures about breastfeeding during pregnancy, and the status of wanting to receive free breastfeeding training after delivery.
1 secondary outcome
Breastfeeding Knowledge Level Diagnosis Form
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Derived from this study: PubMed 37610927Akturk NBK, Kolcu M. The effect of postnatal breastfeeding education given to women on breastfeeding self-efficacy and breastfeeding success. Rev Assoc Med Bras (1992). 2023 Aug 21;69(8):e20230217. doi: 10.1590/1806-9282.20230217. eCollection 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 education in people with Breastfeeding, run by Saglik Bilimleri Universitesi 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 8 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: finished, as of the sponsor's last update on 28 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Introductory Information Form (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666817, which also lists 1 linked publication.
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 28 Dec 2022.