BreastfeedingNCT06313034
The Effect of Breastfeeding Training Given to Mothers With Vaginal Birth by Motivational Interview Technique
A study testing Breastfeeding education based on motivational interviewing technique in people with Breastfeeding, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding education based on motivational interviewing technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 Mar 2024
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal criteria;
- Agreeing to participate in the research
- Being 20 years or older
- Having had a vaginal birth
- being primiparous
- Being at least a primary school graduate
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- Ability to speak Turkish
- Not having any condition that would prevent communication
- No medical breast problem
- Criteria for the baby;
- Being born at term (38-41 gestational weeks)
- There is no congenital anomaly such as cleft palate or lip of the newborn that may prevent sucking.
- Birth weight over 2500 grams
Who cannot join
- Maternal criteria;
- Having a chronic disease that prevents breastfeeding
- Having major breast problems that will prevent breastfeeding
- The mother has a diagnosed psychiatric disease
- Having 2 or more live newborns in this birth
- Criteria for the baby;
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- Premature birth (37th gestational week and before)
- Having a congenital disease
- Being in the risk group/being diagnosed with a disease in the newborn screening program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gümüşhane University
Gümüşhane
ÖZGE PALANCI AY
About this study
Official title: The Effect of Breastfeeding Training for Mothers Who Have a Vaginal Birth With Motivational Interview Technique on Their Breastfeeding Motivation, Self-efficacy, and Attachment
This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial.
Read the detailed description
The study will be conducted as a single-blind, randomized controlled trial with 80 mothers who gave birth vaginally. In the experimental group, just before discharge from the hospital (within the last 4 hours before discharge), on the 2nd-5th, 13th-17th, 30th-42nd days after birth. Breastfeeding training based on motivational interviewing technique will be given 4 times in total. The control group will continue to receive the current standard care and service of the relevant hospital and other postpartum health institutions.
Hypotheses of the Research
- The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the mother's breastfeeding motivation. are there?(H1)
- Breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique has no effect on increasing the mother's breastfeeding self-efficacy. Does it have any effect?(H2)
- The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the level of mother-infant attachment. are there?(H3)
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding education based on motivational interviewing technique
- Keywords
- Attachment, Breastfeeding Motivation, Breastfeeding Self-Efficacy, Mother, Motivational Interview
- 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 education based on motivational interviewing techniqueBehavioural
Breastfeeding education based on motivational interviewing technique; Breast milk properties, benefits to mother and baby, breastfeeding positions, the relationship between breastfeeding and attachment, signs of hunger in the newborn, Breastfeeding frequency, duration and termination, Breast milk expressing methods, Expressions showing that the newborn has enough milk, Breast milk storage will cover the topics. These topics will be given based on motivational interviewing technique.
According to the motivational interviewing technique, the mother's "intention, importance and confidence-sufficiency" regarding breastfeeding will be determined and firstly, an agenda will be created on "issues related to breastfeeding with the mother". Each session will be conducted by following the "open-ended questioning, verification, reflective listening and summarizing" approaches of the motivational interviewing technique.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Breastfeeding education will be given to mothers in the experimental group in 4 individual and face-to-face sessions based on motivational interviewing technique.
The first session of breastfeeding training based on motivational interviewing technique will be held in the delivery room where the mother is hospitalized before being discharged from the hospital. Other sessions will be held according to the monitoring frequency recommended in the Postnatal Care Management Guide of the Ministry of Health of the Republic of Turkey (2018). These will be done at the health institution where the mother receives service.
Second session; Between the 2th and 5th postpartum day Third session; Between the 13th and 17th postpartum day Fourth session; Between the 30th and 42th postpartum day The duration of each motivational interview is planned to be between 30-40 minutes on average. Receives: Behavioral: Breastfeeding education based on motivational interviewing technique |
| control group | No intervention | Before discharge, mothers in the control group will be given routine breastfeeding training by the midwife working in the delivery room in accordance with the mother/baby friendly hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother Introductory Information Form
It was prepared in line with the literature. The form consists of a total of 27 questions, including information about socio-demographic information, obstetric, newborn characteristics.breastfeeding characteristics
Measured: one day
Primipara Breastfeeding Motivation Scale
It was developed to determine the factors affecting breastfeeding motivation in primiparous women. The scale is a 7-point Likert type, consisting of a total of 29 items and 4 sub-dimensions. These sub-dimensions; the value placed on breastfeeding, self-efficacy, perceived midwife support and expectation of success. There is no cut-off value and total score in the evaluation of the scale. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases.
Measured: Three months
Breastfeeding Self-Efficacy Scale Short Form
The scale is a 5-point Likert type and consists of 14 questions in total. The lowest score that can be obtained from the scale is 14 and the highest score is 70. High scores are interpreted as high breastfeeding self-efficacy.
Measured: Three months
Mother-Baby Attachment Scale
The scale has a total of 8 items and is a 4-point Likert type. Responses are scored between 0-3. In the evaluation, items with positive emotion expressions (1, 4, 6.) were scored as 0, 1, 2, 3, while items with negative emotion expressions (2, 3, 5, 7, 8.) were scored as 3, 2, 1,0. It is scored as. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score obtained from the scale increases, the level of mother-infant attachment decreases
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 May 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (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.
- 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 sample of the research will consist of mothers who gave primary vaginal birth (40 experimental group and 40 control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Özge PALANCI AY, Gümüşhane Universıty
- Investigators
- ÖZGE PALANCI AY, Principal investigator, Gümüşhane UniversıtySONGÜL AKTAŞ, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313034
- Sponsor's protocol ID
- GU-SBF-OPA-02
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Training for Mothers Who Have a Vaginal Birth With Motivational Interview Technique on Their Breastfeeding Motivation, Self-efficacy, and Attachment
- ClinicalTrials.gov ID
- NCT06313034
- Acronym / sponsor ID
- GU-SBF-OPA-02
- Conditions
- Breastfeeding
- Keywords
- Attachment, Breastfeeding Motivation, Breastfeeding Self-Efficacy, Mother, Motivational Interview
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 15 Mar 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.
This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial.
Detailed description
The study will be conducted as a single-blind, randomized controlled trial with 80 mothers who gave birth vaginally. In the experimental group, just before discharge from the hospital (within the last 4 hours before discharge), on the 2nd-5th, 13th-17th, 30th-42nd days after birth. Breastfeeding training based on motivational interviewing technique will be given 4 times in total. The control group will continue to receive the current standard care and service of the relevant hospital and other postpartum health institutions.
Hypotheses of the Research
- The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the mother's breastfeeding motivation. are there?(H1)
- Breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique has no effect on increasing the mother's breastfeeding self-efficacy. Does it have any effect?(H2)
- The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the level of mother-infant attachment. are there?(H3)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample of the research will consist of mothers who gave primary vaginal birth (40 experimental group and 40 control group)
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Breastfeeding education based on motivational interviewing techniqueBreastfeeding education will be given to mothers in the experimental group in 4 individual and face-to-face sessions based on motivational interviewing technique. The first session of breastfeeding training based on motivational interviewing technique will be held in the delivery room where the mother is hospitalized before being discharged from the hospital. Other sessions will be held according to the monitoring frequency recommended in the Postnatal Care Management Guide of the Ministry of Health of the Republic of Turkey (2018). These will be done at the health institution where the mother receives service. Second session; Between the 2th and 5th postpartum day Third session; Between the 13th and 17th postpartum day Fourth session; Between the 30th and 42th postpartum day The duration of each motivational interview is planned to be between 30-40 minutes on average. |
| control group | No intervention | –Before discharge, mothers in the control group will be given routine breastfeeding training by the midwife working in the delivery room in accordance with the mother/baby friendly hospital protocol. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Maternal criteria;
- Agreeing to participate in the research
- Being 20 years or older
- Having had a vaginal birth
- being primiparous
Key exclusion criteria (9 listed)
- Maternal criteria;
- Having a chronic disease that prevents breastfeeding
- Having major breast problems that will prevent breastfeeding
- The mother has a diagnosed psychiatric disease
- Having 2 or more live newborns in this birth
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 education based on motivational interviewing techniqueBreastfeeding education based on motivational interviewing technique; Breast milk properties, benefits to mother and baby, breastfeeding positions, the relationship between breastfeeding and attachment, signs of hunger in the newborn, Breastfeeding frequency, duration and termination, Breast milk expressing methods, Expressions showing that the newborn has enough milk, Breast milk storage will cover the topics. These topics will be given based on motivational interviewing technique. According to the motivational interviewing technique, the mother's "intention, importance and confidence-sufficiency" regarding breastfeeding will be determined and firstly, an agenda will be created on "issues related to breastfeeding with the mother". Each session will be conducted by following the "open-ended questioning, verification, reflective listening and summarizing" approaches of the motivational interviewing technique. | Behavioural | experimental group |
Primary outcome
Mother Introductory Information Form
Time frame: one day
It was prepared in line with the literature. The form consists of a total of 27 questions, including information about socio-demographic information, obstetric, newborn characteristics.breastfeeding characteristics
Primipara Breastfeeding Motivation Scale
Time frame: Three months
It was developed to determine the factors affecting breastfeeding motivation in primiparous women. The scale is a 7-point Likert type, consisting of a total of 29 items and 4 sub-dimensions. These sub-dimensions; the value placed on breastfeeding, self-efficacy, perceived midwife support and expectation of success. There is no cut-off value and total score in the evaluation of the scale. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases.
Breastfeeding Self-Efficacy Scale Short Form
Time frame: Three months
The scale is a 5-point Likert type and consists of 14 questions in total. The lowest score that can be obtained from the scale is 14 and the highest score is 70. High scores are interpreted as high breastfeeding self-efficacy.
Mother-Baby Attachment Scale
Time frame: Three months
The scale has a total of 8 items and is a 4-point Likert type. Responses are scored between 0-3. In the evaluation, items with positive emotion expressions (1, 4, 6.) were scored as 0, 1, 2, 3, while items with negative emotion expressions (2, 3, 5, 7, 8.) were scored as 3, 2, 1,0. It is scored as. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score obtained from the scale increases, the level of mother-infant attachment decreases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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. This study is not recruiting at the moment.
ÖZGE PALANCI AY principal investigator
Gümüşhane Universıty
SONGÜL AKTAŞ principal investigator
Karadeniz Technical 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 Breastfeeding education based on motivational interviewing technique in people with Breastfeeding, run by Gümüşhane Universıty 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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ÖZGE PALANCI AY (05428933629, ozge.plnci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother Introductory Information Form (time frame: one day). 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 15 Mar 2024.