BreastfeedingNCT05562245
Motivational Interviewing-Based Breastfeeding Education
A study testing Motivational Interviewing-Based Breastfeeding Education in people with Breastfeeding and Motivation, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The general purpose of this project is; to evaluate effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section. 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
- Breastfeeding, Motivation, Success
- What is being tested?
- Motivational Interviewing-Based Breastfeeding Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2022to 10 Oct 2023
- 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
- Volunteer to participate in the study,
- Cesarean delivery,
- Does not have a condition that prevents breastfeeding,
- Married
- Primiparous,
- Not receiving general anesthesia,
Show all 12Show fewer
- At least primary school graduate,
- 18 years and above,
- Do not have any chronic disease,
- The birth weight of the baby is 2500 g and above,
- Your baby's APGAR score is 7 and above in the 5th minute,
- Mothers whose babies do not have congenital and/or metabolic diseases will be included in the study.
Who cannot join
- Having multiple pregnancy and giving birth,
- Foreign nationals and do not speak Turkish,
- Having a history of preeclampsia, eclampsia and gestational diabetes,
- Mothers who develop complications during cesarean section and whose transfer to the service exceeds 1 hour (because breastfeeding will be delayed for the first hour),
- COVID-19 positive in the 1st hour after birth and having a condition that prevents breastfeeding,
- Those with a history of diagnosed mental or psychiatric illness will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interviewing-Based Breastfeeding Education on Breastfeeding Motivation, Breastfeeding Success, and Breastfeeding Self-Efficacy Perceptions After Cesarean Section
The general purpose of this project is; to evaluate effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
The sub-aims of the study were to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding outcomes of primiparous mothers who gave birth by cesarean section.
The study will be conducted between September 2022- March 2023 at Konya a private hospital.
Read the detailed description
The research was planned as a randomized controlled experimental study. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list.
A total of 80 primiparous mothers who gave birth by cesarean section, 40 in the experimental group and 40 in the control group, will be included in the study.
Pre-Test Information Collection Form at the 1st hour after Caesarean section, Postpartum 5-7. Day Follow-up Form, Postpartum 6th Week Follow-Up Form and Postpartum 3rd Month Follow-up Form, LATCH Breastfeeding Assessment Tool, Breastfeeding Self-Efficacy Short Form Scale, The Primipara Breastfeeding Motivation Scale, Confidence-sufficiency and importance a scale.
Breastfeeding education based on motivational interviewing will be held for mothers in the experimental group, 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. Routine breastfeeding training of the hospital will be given to mothers in the control group 1st hour after cesarean section and will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
The breastfeeding guide prepared by the researcher will be given to the mothers in the experimental and control groups.
- Conditions
- Breastfeeding, Motivation, Success, Self-Efficacy
- Being tested
- Motivational Interviewing-Based Breastfeeding Education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing-Based Breastfeeding EducationOther
Motivational interviewing is basically a directive and client-centered psychosocial intervention used to help individuals discover and analyze ambivalent emotions related to their health behaviors, to learn new skills and to improve their existing skills. One of the main guiding principles in motivational interviewing is self-support and empowerment. The interviews consist of one to four sessions lasting between 7.5-60 minutes.
A total of four motivational interviews will be held with the mothers in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 1. 1st hour after cesarean section Pre-tests and motivational interviewing-based breastfeeding education
2. Postpartum 5-7th Day: When the mothers come to the hospital for control, a second motivational interviewing session will be held in the breastfeeding room and breastfeeding will be supported when necessary and a second measurement will be made.
3. Postpartum 6th Week: The third motivational interviewing session will be held by going to the mothers' homes, breastfeeding will be supported when necessary and a third measurement will be made.
4. Postpartum 3rd Month: In order to end the motivational interviewing, the fourth motivational interviewing session will be held by going to the mothers' homes and the fourth measurement will be made. Receives: Other: Motivational Interviewing-Based Breastfeeding Education |
| Control arm | No intervention | 1st hour after cesarean section will be made pre-tests and routine breastfeeding training of the hospital will be given to mothers in the control group. Mothers will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Assessment Tool
The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10.
Measured: Change from LATCH Breastfeeding Assessment Tool at 3 months
Breastfeeding Self-Efficacy Short Form Scale
The scale consists of 33 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained
Measured: Change from Breastfeeding Self-Efficacy Short Form Scale at 3 months
The Primipara Breastfeeding Motivation Scale
The Primipara Breastfeeding Motivation Scale: The scale consists of 29 items and is scored between 1-7. It has a total of four sub-dimensions. Evaluation is made by summing the scores obtained in each subgroup in the scale.
Measured: Change from The Primipara Breastfeeding Motivation Scale at 3 months
Confidence- sufficiency and importance a scale
It is a grading scale prepared in the form of a visual analog scale. The score that can be obtained from the scale varies in the range of 0-10 points.
Measured: Change from Confidence- sufficiency and importance a scale at 3 months
Secondary outcomes (2)
Rate of feeding the baby with only breast milk
1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month
Measured: 3 months
Total breastfeeding time
1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start19 Sep 2022
- Primary completion30 Mar 2023
- Study completion10 Oct 2023
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.
- 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 was planned in a randomized controlled experimental design to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Bekmezci, Selcuk University
- Investigators
- Halime Esra Meram, PhD, Study director, esrameran@selcuk.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562245
- Sponsor's protocol ID
- 2022/28
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing-Based Breastfeeding Education on Breastfeeding Motivation, Breastfeeding Success, and Breastfeeding Self-Efficacy Perceptions After Cesarean Section
- ClinicalTrials.gov ID
- NCT05562245
- Acronym / sponsor ID
- 2022/28
- Conditions
- Breastfeeding, Motivation, Success, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 30 Sep 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.
The general purpose of this project is; to evaluate effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
The sub-aims of the study were to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding outcomes of primiparous mothers who gave birth by cesarean section.
The study will be conducted between September 2022- March 2023 at Konya a private hospital.
Detailed description
The research was planned as a randomized controlled experimental study. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list.
A total of 80 primiparous mothers who gave birth by cesarean section, 40 in the experimental group and 40 in the control group, will be included in the study.
Pre-Test Information Collection Form at the 1st hour after Caesarean section, Postpartum 5-7. Day Follow-up Form, Postpartum 6th Week Follow-Up Form and Postpartum 3rd Month Follow-up Form, LATCH Breastfeeding Assessment Tool, Breastfeeding Self-Efficacy Short Form Scale, The Primipara Breastfeeding Motivation Scale, Confidence-sufficiency and importance a scale.
Breastfeeding education based on motivational interviewing will be held for mothers in the experimental group, 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. Routine breastfeeding training of the hospital will be given to mothers in the control group 1st hour after cesarean section and will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
The breastfeeding guide prepared by the researcher will be given to the mothers in the experimental and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned in a randomized controlled experimental design to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Motivational Interviewing-Based Breastfeeding Education1. 1st hour after cesarean section Pre-tests and motivational interviewing-based breastfeeding education 2. Postpartum 5-7th Day: When the mothers come to the hospital for control, a second motivational interviewing session will be held in the breastfeeding room and breastfeeding will be supported when necessary and a second measurement will be made. 3. Postpartum 6th Week: The third motivational interviewing session will be held by going to the mothers' homes, breastfeeding will be supported when necessary and a third measurement will be made. 4. Postpartum 3rd Month: In order to end the motivational interviewing, the fourth motivational interviewing session will be held by going to the mothers' homes and the fourth measurement will be made. |
| Control arm | No intervention | –1st hour after cesarean section will be made pre-tests and routine breastfeeding training of the hospital will be given to mothers in the control group. Mothers will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Volunteer to participate in the study,
- Cesarean delivery,
- Does not have a condition that prevents breastfeeding,
- Married
- Primiparous,
Key exclusion criteria (6 listed)
- Having multiple pregnancy and giving birth,
- Foreign nationals and do not speak Turkish,
- Having a history of preeclampsia, eclampsia and gestational diabetes,
- Mothers who develop complications during cesarean section and whose transfer to the service exceeds 1 hour (because breastfeeding will be delayed for the first hour),
- COVID-19 positive in the 1st hour after birth and having a condition that prevents breastfeeding,
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 |
|---|---|---|
| Motivational Interviewing-Based Breastfeeding EducationMotivational interviewing is basically a directive and client-centered psychosocial intervention used to help individuals discover and analyze ambivalent emotions related to their health behaviors, to learn new skills and to improve their existing skills. One of the main guiding principles in motivational interviewing is self-support and empowerment. The interviews consist of one to four sessions lasting between 7.5-60 minutes. A total of four motivational interviews will be held with the mothers in the experimental group. | Other | Intervention arm |
Primary outcome
LATCH Breastfeeding Assessment Tool
Time frame: Change from LATCH Breastfeeding Assessment Tool at 3 months
The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10.
Breastfeeding Self-Efficacy Short Form Scale
Time frame: Change from Breastfeeding Self-Efficacy Short Form Scale at 3 months
The scale consists of 33 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained
The Primipara Breastfeeding Motivation Scale
Time frame: Change from The Primipara Breastfeeding Motivation Scale at 3 months
The Primipara Breastfeeding Motivation Scale: The scale consists of 29 items and is scored between 1-7. It has a total of four sub-dimensions. Evaluation is made by summing the scores obtained in each subgroup in the scale.
Confidence- sufficiency and importance a scale
Time frame: Change from Confidence- sufficiency and importance a scale at 3 months
It is a grading scale prepared in the form of a visual analog scale. The score that can be obtained from the scale varies in the range of 0-10 points.
2 secondary outcomes
Rate of feeding the baby with only breast milk
Time frame: 3 months
Total breastfeeding time
Time frame: 3 months
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 5 Jan 2024.
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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.
Halime Esra Meram, PhD study director
esrameran@selcuk.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing-Based Breastfeeding Education in people with Breastfeeding and Motivation, run by Selcuk 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 12 inclusion and 6 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 5 Jan 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?
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?
LATCH Breastfeeding Assessment Tool (time frame: Change from LATCH Breastfeeding Assessment Tool at 3 months). The study lists 4 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 5 Jan 2024.