PostpartumBFNCT04515862
Hospital-Based Breastfeeding Training İn The Early Postpartum Period
A study testing Breastfeeding education in people with Postpartum and Women, run by Ege University.
Trial summary
H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Women, Education
- What is being tested?
- Breastfeeding education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 15 Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can be contacted,
- had a single birth,
- Those who are 18 years old or older,
- Residing in Izmir,
- able to use phone
- were determined to be mothers with no health problems in the mother and the baby
Who cannot join
- -
About this study
Official title: A Randomızed Controlled Study On Analysıs Of Effect Of Hospıtal Based Breast-Feedıng Group Traınıng Provıded In Early Postpartum Perıod About Breast-Feedıng Self-Effıcacy And Breast-Feedıng Status Of Maternals
H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care.
H2: The level of knowledge obtained according to the "Pre-test Post-test Question Form" in mothers who received postnatal hospital-based breastfeeding group training is higher than before the education.
H3: The status of starting and successfully continuing breastfeeding is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group who received routine care.
Read the detailed description
Follow-up data of all mothers were collected by phone at 4 and 12 weeks. For this reason, the phone numbers of the mothers and a relative were recorded.
- Conditions
- Postpartum, Women, Education
- Being tested
- Breastfeeding education
- Keywords
- Breastfeeding, group training, Self-Effıcacy
- 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
The importance of breastfeeding Benefits of breastfeeding for mother and baby Structure of the breast and milk production Breastfeeding techniques and positions Breastfeeding problems and breast care
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Intervention group: Mothers in the intervention group were included in the breastfeeding training program with the group training method. The training program was developed by the researchers, and the content of the program was evaluated with the expert opinion of academicians, obstetricians, nurses and breastfeeding counselor midwives working on breastfeeding. Receives: Other: Breastfeeding education |
| control | No intervention | Control Group:Routine obstetric care and treatment procedures were applied to the mothers in the control group. In the hospital where the study was conducted, all mothers are routinely evaluated for breastfeeding by an infant nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale
This scale was developed by Cindy-Lee Dennis to measure breastfeeding competence and consists of 2 subscales and 33 items. The Turkish validity and reliability of the breastfeeding proficiency scale was made by Ekşioğlu and Çeber (2011). Breastfeeding self-efficacy increases as the total score increases in the 5-point Likert-type scale with a Cronbach Alpha coefficient of 0.91. The lowest score is 33, the highest score is 165.
Measured: twelve weeks
Pre-Test Post-Test Information Form
It is a question form consisting of 25 questions in order to evaluate the knowledge about breastfeeding and breast milk before and after the training. The first application was done before the training and the second application was carried out in the 12th week.
Measured: twelve weeks
Breastfeeding levels of mothers
The exclusive breastfeeding levels of their babies in the fourth and twelfth weeks of the mothers who received and did not receive education were evaluated.
Measured: four weeks, twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Aug 2015
- Primary completion30 Jan 2016
- Study completion15 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Ege 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study was applied to mothers who gave birth at a time when they felt well after being taken to their postnatal room. First, the mothers who met the inclusion criteria were informed, after obtaining written consent, the mothers were randomized using a random number table and then assigned to the intervention and control groups. All mothers were asked to fill in the breastfeeding self-efficacy scale form together with the questionnaire before the intervention. Later, a training program was conducted in the hospital with the mothers in the intervention group. In the data collection phase of the study, 1180 women were evaluated in terms of sampling criteria. 1152 women (who did not meet the criteria or refused to participate) were excluded from the study. 90 randomized women were divided into two groups as intervention and control group. During the follow-up, 5 women in the intervention group and 5 women in the control group were excluded from the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEŞİM YEŞİL, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515862
- Sponsor's protocol ID
- Yesim Yesil
- Acronym
- BF
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
PubMed 26792873Yilmaz M, Aykut M. The effect of breastfeeding training on exclusive breastfeeding: a randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Mar;34(6):925-932. doi: 10.1080/14767058.2019.1622672. Epub 2019 Jul 25.
PubMed 31345049Eksioglu AB, Ceber E. Translation and validation of the Breast-feeding Self-efficacy Scale into Turkish. Midwifery. 2011 Dec;27(6):e246-53. doi: 10.1016/j.midw.2010.10.009. Epub 2010 Dec 8.
PubMed 21145148
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomızed Controlled Study On Analysıs Of Effect Of Hospıtal Based Breast-Feedıng Group Traınıng Provıded In Early Postpartum Perıod About Breast-Feedıng Self-Effıcacy And Breast-Feedıng Status Of Maternals
- ClinicalTrials.gov ID
- NCT04515862
- Acronym / sponsor ID
- BF / Yesim Yesil
- Conditions
- Postpartum, Women, Education
- Keywords
- Breastfeeding, group training, Self-Effıcacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 17 Aug 2020 (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.
H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care.
H2: The level of knowledge obtained according to the "Pre-test Post-test Question Form" in mothers who received postnatal hospital-based breastfeeding group training is higher than before the education.
H3: The status of starting and successfully continuing breastfeeding is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group who received routine care.
Detailed description
Follow-up data of all mothers were collected by phone at 4 and 12 weeks. For this reason, the phone numbers of the mothers and a relative were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was applied to mothers who gave birth at a time when they felt well after being taken to their postnatal room. First, the mothers who met the inclusion criteria were informed, after obtaining written consent, the mothers were randomized using a random number table and then assigned to the intervention and control groups. All mothers were asked to fill in the breastfeeding self-efficacy scale form together with the questionnaire before the intervention. Later, a training program was conducted in the hospital with the mothers in the intervention group. In the data collection phase of the study, 1180 women were evaluated in terms of sampling criteria. 1152 women (who did not meet the criteria or refused to participate) were excluded from the study. 90 randomized women were divided into two groups as intervention and control group. During the follow-up, 5 women in the intervention group and 5 women in the control group were excluded from the study.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Breastfeeding educationIntervention group: Mothers in the intervention group were included in the breastfeeding training program with the group training method. The training program was developed by the researchers, and the content of the program was evaluated with the expert opinion of academicians, obstetricians, nurses and breastfeeding counselor midwives working on breastfeeding. |
| control | No intervention | –Control Group:Routine obstetric care and treatment procedures were applied to the mothers in the control group. In the hospital where the study was conducted, all mothers are routinely evaluated for breastfeeding by an infant nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Can be contacted,
- had a single birth,
- Those who are 18 years old or older,
- Residing in Izmir,
- able to use phone
Key exclusion criteria (1 listed)
- -
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 educationThe importance of breastfeeding Benefits of breastfeeding for mother and baby Structure of the breast and milk production Breastfeeding techniques and positions Breastfeeding problems and breast care | Other | intervention |
Primary outcome
Breastfeeding Self-Efficacy Scale
Time frame: twelve weeks
This scale was developed by Cindy-Lee Dennis to measure breastfeeding competence and consists of 2 subscales and 33 items. The Turkish validity and reliability of the breastfeeding proficiency scale was made by Ekşioğlu and Çeber (2011). Breastfeeding self-efficacy increases as the total score increases in the 5-point Likert-type scale with a Cronbach Alpha coefficient of 0.91. The lowest score is 33, the highest score is 165.
Pre-Test Post-Test Information Form
Time frame: twelve weeks
It is a question form consisting of 25 questions in order to evaluate the knowledge about breastfeeding and breast milk before and after the training. The first application was done before the training and the second application was carried out in the 12th week.
Breastfeeding levels of mothers
Time frame: four weeks, twelve weeks
The exclusive breastfeeding levels of their babies in the fourth and twelfth weeks of the mothers who received and did not receive education were evaluated.
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 18 Aug 2020.
- Background: PubMed 14649593Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background: PubMed 26792873Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
- Background: PubMed 31345049Yilmaz M, Aykut M. The effect of breastfeeding training on exclusive breastfeeding: a randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Mar;34(6):925-932. doi: 10.1080/14767058.2019.1622672. Epub 2019 Jul 25.
- Background: PubMed 21145148Eksioglu AB, Ceber E. Translation and validation of the Breast-feeding Self-efficacy Scale into Turkish. Midwifery. 2011 Dec;27(6):e246-53. doi: 10.1016/j.midw.2010.10.009. Epub 2010 Dec 8.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding education in people with Postpartum and Women, run by Ege 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 6 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 18 Aug 2020. 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?
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?
Breastfeeding Self-Efficacy Scale (time frame: twelve weeks). The study lists 3 primary outcomes in all. 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 NCT04515862, which also lists 4 linked publications.
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 18 Aug 2020.