BreastfeedingNCT06971302
Effect of Mindfulness Based Breastfeeding Education on Mothers' Breastfeeding Parameters
A study testing Mindfullnes Based Breastfeeding Education in people with Breastfeeding, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Pregnant women followed at the Tece Family Health Center were contacted via telephone and informed about the study. Pregnant women who expressed interest in participating were assessed according to the inclusion and exclusion criteria using the "Eligibility Assessment Form" prepared by the researcher. 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
- What is being tested?
- Mindfullnes Based Breastfeeding Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2024to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- For pregnant women:
- Who are 18 years or older,
- Who are literate,
- Who are in their 24th to 28th week of pregnancy,
- Who are expecting a singleton pregnancy,
- Who are willing to participate in the study,
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- Whose breastfeeding self-efficacy score is below 57,
- Who agree to home visits postpartum for interviews,
- Who do not have any health issues that would prevent breastfeeding,
- Who do not have any communication barriers.
Who cannot join
- For pregnant women who:
- Are under 18 years old,
- Are illiterate,
- Have a gestational age less than 24 weeks or greater than 28 weeks,
- Have a multiple pregnancy,
- Do not wish to breastfeed,
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- Have any health issues that would prevent breastfeeding (such as mastectomy, medication use, HIV, etc.),
- Do not speak Turkish,
- Have any psychiatric issues,
- Have a breastfeeding self-efficacy score higher than 57,
- Cannot attend more than two sessions for any reason during the study period,
- Are illiterate,
- Do not sign the Informed Consent Form,
- Do not agree to home visits postpartum for interviews.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Based Breastfeeding Education Given During Pregnancy on Mothers' of Breastfeeding Self-Efficacy Perception, Effectiveness and Mindful
Pregnant women followed at the Tece Family Health Center were contacted via telephone and informed about the study. Pregnant women who expressed interest in participating were assessed according to the inclusion and exclusion criteria using the "Eligibility Assessment Form" prepared by the researcher. Those who met the research criteria were randomly assigned to either the intervention or the control group.
Before starting the Mindfulness-Based Breastfeeding Education, all participants in both groups were asked to complete the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.
Read more
The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher, both face-to-face and online, on predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make the content more memorable and easier to understand. After the final session of the six-week training program, the participants completed the Antenatal Breastfeeding Self-Efficacy Scale. Mothers were asked to inform the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale.
No intervention was applied to the pregnant women in the control group. Six weeks after the first administration of the Antenatal Breastfeeding Self-Efficacy Scale, the same scale was administered again. Mothers were asked to notify the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following forms and scales were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale.
In order to eliminate any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group after the data collection process had been completed.
Read the detailed description
The content of the Mindfulness-Based Breastfeeding Education was developed by the researchers based on a comprehensive review of the relevant literature. To evaluate the appropriateness of the educational content, feedback was obtained from expert faculty members with academic experience in breastfeeding and/or mindfulness-related studies.
A list of pregnant women being followed at the Tece Family Health Center was compiled, and those who were interested in participating were provided with general information about the study. Additionally, the researcher shared her contact information with these pregnant women.
Pregnant women who expressed willingness to participate and contacted the researcher were assessed for eligibility using a "Eligibility Assessment Form" prepared by the researcher. Those who met the inclusion criteria were randomly assigned to either the intervention or the control group. The participants were then asked to complete the Informed Consent Form, Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.
To facilitate communication with the intervention group, a WhatsApp group was created. Taking into account the needs of the participants and previous studies, appropriate days and times were scheduled for the six-week Mindfulness-Based Breastfeeding Education Program, consisting of weekly two-hour sessions. Participants in the intervention group were divided into subgroups of no more than seven individuals each.
In total, the intervention group received 12 sessions of mindfulness-based breastfeeding education, delivered according to the scheduled days and times. To minimize participant dropout, the program was delivered over six weeks, with the first three weeks conducted online and the remaining three weeks conducted face-to-face, each session lasting two hours.
The educational content covered the following themes: introduction to mindfulness, awareness of the body and the "automatic pilot" mode, mindful communication, coping with difficult emotions and situations, integrating mindfulness into daily life, the postpartum period, and the themes of closure and new beginnings. Mindfulness practices were integrated into the breastfeeding experience under each theme.
No intervention was applied to the control group during the six-week period. At the end of the six weeks, both the intervention and control groups completed the Antenatal Breastfeeding Self-Efficacy Scale once again.
After childbirth, mothers whose newborns did not meet the inclusion criteria were excluded from the sample, and new participants were recruited accordingly. IIn the 1st and 8th weeks postpartum, the Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool (BBAT), and the Mindful Breastfeeding Scale (MIND-BFS) were administered to both the intervention and control groups.
To address any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group following the completion of data collection.
- Conditions
- Breastfeeding
- Being tested
- Mindfullnes Based Breastfeeding Education
- Keywords
- minfulness, nursing care, 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.
Mindfullnes Based Breastfeeding EducationOther
Pregnant women in the intervention group will receive mindfulness-based breastfeeding training, conducted face-to-face and online by the researcher at designated days and times. The intervention group will undergo a total of 12 sessions of mindfulness-based breastfeeding training over a six-week period. The training will be made memorable and easy to understand through the support of visual presentations, videos, and models prepared by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Initially, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.No intervention was applied to the pregnant women in the control group. After the first application of the Prenatal Breastfeeding Self-Efficacy Scale, the same scale was applied again six weeks later. Participants were asked to notify the researcher when they gave birth. The following instruments were applied to mothers at 1 and 8 weeks postpartum: * Postpartum Mother-Baby Identifier Form, * Postpartum Breastfeeding Self-Efficacy Scale, * Bristol Breastfeeding Assessment Tool, and * Mindful Breastfeeding Scale. In order to eliminate possible ethical concerns regarding the control group, breastfeeding education was provided to mothers in the control group after the data collection process was completed. |
| Mindfulness based breastfeeding education | Experimental | Before the Mindfulness-Based Breastfeeding Education began, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics For.The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher both face-to-face and online on the predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make it memorable and easy to understand.
After the final session of the six-week training program, the Antenatal Breastfeeding Self-Efficacy Scale was administered to the participants. The mothers were asked to inform the researcher when they gave birth.
In the 1st and 8th weeks postpartum, the following forms and scales were administered to the mothers:
* Postpartum Mother-Infant Descriptive Form,
* Postnatal Breastfeeding Self-Efficacy Scale,
* Bristol Breastfeeding Assessment Tool,
* Mindful Breastfeeding Scale. Receives: Other: Mindfullnes Based Breastfeeding Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding evaluated using the Antenatal Breastfeeding Self-Efficacy Scale
The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher breastfeeding self-efficacy.
Measured: during pregnancy, when the study was started and 6 weeks later
Breastfeeding evaluated using the Postnatal Breastfeeding Self-Efficacy Scale
The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher Change from breastfeeding self-efficacy.
Measured: Change from postpartum 1st and 8th week
Secondary outcomes (1)
Breastfeeding evaluated using the Bristol Breastfeeding Assessment Tool
The lowest score on the scale is 0, and the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Measured: Change from postpartum 1st and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start8 Aug 2024
- Primary completion25 Mar 2025
- Study completion12 Aug 2025 (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.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Dalgalar, Mersin University
- Investigators
- DUYGU VEFİKULUÇAY YILMAZ, PROF, Study chair, Mersin University Faculty of NursingÖZGE DALGALAR, MASTER, Principal investigator, Mersin University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971302
- Sponsor's protocol ID
- 78017789/050.01.04/2621454
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Breastfeeding Education Given During Pregnancy on Mothers' of Breastfeeding Self-Efficacy Perception, Effectiveness and Mindful
- ClinicalTrials.gov ID
- NCT06971302
- Acronym / sponsor ID
- 78017789/050.01.04/2621454
- Conditions
- Breastfeeding
- Keywords
- minfulness, nursing care, breastfeeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 14 May 2025 (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.
Pregnant women followed at the Tece Family Health Center were contacted via telephone and informed about the study. Pregnant women who expressed interest in participating were assessed according to the inclusion and exclusion criteria using the "Eligibility Assessment Form" prepared by the researcher. Those who met the research criteria were randomly assigned to either the intervention or the control group.
Before starting the Mindfulness-Based Breastfeeding Education, all participants in both groups were asked to complete the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.
The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher, both face-to-face and online, on predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make the content more memorable and easier to understand. After the final session of the six-week training program, the participants completed the Antenatal Breastfeeding Self-Efficacy Scale. Mothers were asked to inform the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale.
No intervention was applied to the pregnant women in the control group. Six weeks after the first administration of the Antenatal Breastfeeding Self-Efficacy Scale, the same scale was administered again. Mothers were asked to notify the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following forms and scales were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale.
In order to eliminate any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group after the data collection process had been completed.
Detailed description
The content of the Mindfulness-Based Breastfeeding Education was developed by the researchers based on a comprehensive review of the relevant literature. To evaluate the appropriateness of the educational content, feedback was obtained from expert faculty members with academic experience in breastfeeding and/or mindfulness-related studies.
A list of pregnant women being followed at the Tece Family Health Center was compiled, and those who were interested in participating were provided with general information about the study. Additionally, the researcher shared her contact information with these pregnant women.
Pregnant women who expressed willingness to participate and contacted the researcher were assessed for eligibility using a "Eligibility Assessment Form" prepared by the researcher. Those who met the inclusion criteria were randomly assigned to either the intervention or the control group. The participants were then asked to complete the Informed Consent Form, Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.
To facilitate communication with the intervention group, a WhatsApp group was created. Taking into account the needs of the participants and previous studies, appropriate days and times were scheduled for the six-week Mindfulness-Based Breastfeeding Education Program, consisting of weekly two-hour sessions. Participants in the intervention group were divided into subgroups of no more than seven individuals each.
In total, the intervention group received 12 sessions of mindfulness-based breastfeeding education, delivered according to the scheduled days and times. To minimize participant dropout, the program was delivered over six weeks, with the first three weeks conducted online and the remaining three weeks conducted face-to-face, each session lasting two hours.
The educational content covered the following themes: introduction to mindfulness, awareness of the body and the "automatic pilot" mode, mindful communication, coping with difficult emotions and situations, integrating mindfulness into daily life, the postpartum period, and the themes of closure and new beginnings. Mindfulness practices were integrated into the breastfeeding experience under each theme.
No intervention was applied to the control group during the six-week period. At the end of the six weeks, both the intervention and control groups completed the Antenatal Breastfeeding Self-Efficacy Scale once again.
After childbirth, mothers whose newborns did not meet the inclusion criteria were excluded from the sample, and new participants were recruited accordingly. IIn the 1st and 8th weeks postpartum, the Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool (BBAT), and the Mindful Breastfeeding Scale (MIND-BFS) were administered to both the intervention and control groups.
To address any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group following the completion of data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomize control
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Initially, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.No intervention was applied to the pregnant women in the control group. After the first application of the Prenatal Breastfeeding Self-Efficacy Scale, the same scale was applied again six weeks later. Participants were asked to notify the researcher when they gave birth. The following instruments were applied to mothers at 1 and 8 weeks postpartum: * Postpartum Mother-Baby Identifier Form, * Postpartum Breastfeeding Self-Efficacy Scale, * Bristol Breastfeeding Assessment Tool, and * Mindful Breastfeeding Scale. In order to eliminate possible ethical concerns regarding the control group, breastfeeding education was provided to mothers in the control group after the data collection process was completed. |
| Mindfulness based breastfeeding education | Experimental | Other: Mindfullnes Based Breastfeeding EducationBefore the Mindfulness-Based Breastfeeding Education began, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics For.The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher both face-to-face and online on the predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make it memorable and easy to understand. After the final session of the six-week training program, the Antenatal Breastfeeding Self-Efficacy Scale was administered to the participants. The mothers were asked to inform the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following forms and scales were administered to the mothers: * Postpartum Mother-Infant Descriptive Form, * Postnatal Breastfeeding Self-Efficacy Scale, * Bristol Breastfeeding Assessment Tool, * Mindful Breastfeeding Scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Who are 18 years or older,
- Who are literate,
- Who are in their 24th to 28th week of pregnancy,
- Who are expecting a singleton pregnancy,
- Who are willing to participate in the study,
Key exclusion criteria (14 listed)
- Are under 18 years old,
- Are illiterate,
- Have a gestational age less than 24 weeks or greater than 28 weeks,
- Have a multiple pregnancy,
- Do not wish to breastfeed,
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 |
|---|---|---|
| Mindfullnes Based Breastfeeding EducationPregnant women in the intervention group will receive mindfulness-based breastfeeding training, conducted face-to-face and online by the researcher at designated days and times. The intervention group will undergo a total of 12 sessions of mindfulness-based breastfeeding training over a six-week period. The training will be made memorable and easy to understand through the support of visual presentations, videos, and models prepared by the researcher. | Other | Mindfulness based breastfeeding education |
Primary outcome
Breastfeeding evaluated using the Antenatal Breastfeeding Self-Efficacy Scale
Time frame: during pregnancy, when the study was started and 6 weeks later
The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher breastfeeding self-efficacy.
Breastfeeding evaluated using the Postnatal Breastfeeding Self-Efficacy Scale
Time frame: Change from postpartum 1st and 8th week
The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher Change from breastfeeding self-efficacy.
1 secondary outcome
Breastfeeding evaluated using the Bristol Breastfeeding Assessment Tool
Time frame: Change from postpartum 1st and 8th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- 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.
DUYGU VEFİKULUÇAY YILMAZ, PROF study chair
Mersin University Faculty of Nursing
ÖZGE DALGALAR, MASTER principal investigator
Mersin University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfullnes Based Breastfeeding Education in people with Breastfeeding, run by Mersin 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 evaluated using the Antenatal Breastfeeding Self-Efficacy Scale (time frame: during pregnancy, when the study was started and 6 weeks later). The study lists 2 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 14 May 2025.