Suboptimal BreastfeedingMIND-BFNCT07647211
MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM
A study testing Mindfulness-Based Breastfeeding Education Group in people with Suboptimal Breastfeeding, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding outcomes among mothers who are not exclusively breastfeeding. Participants will be randomly assigned to either the intervention or control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Suboptimal Breastfeeding
- What is being tested?
- Mindfulness-Based Breastfeeding Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2023to 14 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older, being in the first month postpartum, having a full-term, singleton, and healthy infant, and not exclusively breastfeeding the infant (i.e., using formula or other foods in addition to breast milk)
Who cannot join
- Having previously received mindfulness or similar training, having a diagnosed psychiatric disorder, and having any condition that impairs communication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Family Health Centres (FHCs) in the provincial centre of Elazığ, Türkiye
Elâzığ, 23100
About this study
Official title: EFFECT OF MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM ON BREASTFEEDING OUTCOMES IN MOTHERS NOT EXCLUSIVELY BREASTFEEDING: A RANDOMIZED CONTROLLED TRIAL
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding outcomes among mothers who are not exclusively breastfeeding. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive a mindfulness-based breastfeeding education program in addition to routine care. Breastfeeding outcomes, maternal breastfeeding self-efficacy, and related variables will be assessed following the intervention.
Read the detailed description
Breastfeeding is one of the most important practices for improving maternal and infant health. However, many mothers experience difficulties maintaining exclusive breastfeeding during the postpartum period. Psychological stress, anxiety, low breastfeeding confidence, and difficulties adapting to motherhood may negatively affect breastfeeding behaviors and contribute to early supplementation with formula or other foods.
Mindfulness-based approaches have been increasingly used to support maternal psychological well-being and health-related behaviors. These approaches aim to increase awareness of present-moment experiences in a non-judgmental manner and may help mothers engage more consciously in the breastfeeding process. Previous studies suggest that mindfulness-based interventions may improve maternal coping, emotional regulation, and breastfeeding experiences. However, evidence regarding their effectiveness among mothers who are not exclusively breastfeeding remains limited.
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding awareness, breastfeeding self-efficacy, and exclusive breastfeeding rates among postpartum mothers who are not exclusively breastfeeding. Participants are randomly assigned to either a mindfulness-based breastfeeding education group or a control group receiving routine postpartum care. The intervention includes structured breastfeeding education combined with mindfulness-based practices conducted over four weeks. Outcomes are assessed at baseline, immediately after the intervention, and during follow-up assessments postpartum.
- Conditions
- Suboptimal Breastfeeding
- Being tested
- Mindfulness-Based Breastfeeding Education Group
- Keywords
- breastfeeding, midwife, mindfulness, self-efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Breastfeeding Education GroupBehavioural
Also called mindful breastfeeding group
A 4-week mindfulness-based breastfeeding education program was implemented, consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The intervention combined breastfeeding education with mindfulness-based stress reduction techniques, including breathing meditation, body scan meditation, sitting meditation, mountain meditation, and loving-kindness (Metta) meditation. Practical breastfeeding training was provided using a doll and breast model to support skill acquisition. Participants were also given audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice in addition to routine postpartum care.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Breastfeeding Education Group | Experimental | Participants received a 4-week mindfulness-based breastfeeding education program consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The program combined breastfeeding education with mindfulness-based stress reduction techniques (breathing meditation, body scan, sitting meditation, mountain meditation, and loving-kindness meditation). Practical breastfeeding training was supported using a doll and breast model. Participants also received audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice, in addition to routine postpartum care. Receives: Behavioral: Mindfulness-Based Breastfeeding Education Group |
| Control Group | No intervention | Participants received routine postpartum follow-up and standard breastfeeding counseling provided at Family Health Centres. No additional mindfulness-based intervention was administered. Counseling included brief education and support related to breastfeeding as part of standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Breastfeeding Scale
This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period. The scale is unidimensional and was developed using a 5-point Likert scale. Responses to the scale items range from "always" to "never." The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.
Measured: Baseline, 4th week postpartum, 4th month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start31 Oct 2023
- Primary completion15 Apr 2025
- Study completion14 Jul 2025
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 Suboptimal 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray KURT, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647211
- Sponsor's protocol ID
- 2023/5132
- Other IDs
- 966799
- Acronym
- MIND-BF
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant confidentiality and in accordance with ethical approval and informed consent restrictions.
Publications
Kurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM ON BREASTFEEDING OUTCOMES IN MOTHERS NOT EXCLUSIVELY BREASTFEEDING: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07647211
- Acronym / sponsor ID
- MIND-BF / 2023/5132
- Conditions
- Suboptimal Breastfeeding
- Keywords
- breastfeeding, midwife, mindfulness, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 15 Jun 2026 (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 randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding outcomes among mothers who are not exclusively breastfeeding. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive a mindfulness-based breastfeeding education program in addition to routine care. Breastfeeding outcomes, maternal breastfeeding self-efficacy, and related variables will be assessed following the intervention.
Detailed description
Breastfeeding is one of the most important practices for improving maternal and infant health. However, many mothers experience difficulties maintaining exclusive breastfeeding during the postpartum period. Psychological stress, anxiety, low breastfeeding confidence, and difficulties adapting to motherhood may negatively affect breastfeeding behaviors and contribute to early supplementation with formula or other foods.
Mindfulness-based approaches have been increasingly used to support maternal psychological well-being and health-related behaviors. These approaches aim to increase awareness of present-moment experiences in a non-judgmental manner and may help mothers engage more consciously in the breastfeeding process. Previous studies suggest that mindfulness-based interventions may improve maternal coping, emotional regulation, and breastfeeding experiences. However, evidence regarding their effectiveness among mothers who are not exclusively breastfeeding remains limited.
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding awareness, breastfeeding self-efficacy, and exclusive breastfeeding rates among postpartum mothers who are not exclusively breastfeeding. Participants are randomly assigned to either a mindfulness-based breastfeeding education group or a control group receiving routine postpartum care. The intervention includes structured breastfeeding education combined with mindfulness-based practices conducted over four weeks. Outcomes are assessed at baseline, immediately after the intervention, and during follow-up assessments postpartum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Breastfeeding Education Group | Experimental | Behavioral: Mindfulness-Based Breastfeeding Education GroupParticipants received a 4-week mindfulness-based breastfeeding education program consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The program combined breastfeeding education with mindfulness-based stress reduction techniques (breathing meditation, body scan, sitting meditation, mountain meditation, and loving-kindness meditation). Practical breastfeeding training was supported using a doll and breast model. Participants also received audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice, in addition to routine postpartum care. |
| Control Group | No intervention | –Participants received routine postpartum follow-up and standard breastfeeding counseling provided at Family Health Centres. No additional mindfulness-based intervention was administered. Counseling included brief education and support related to breastfeeding as part of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being 18 years of age or older, being in the first month postpartum, having a full-term, singleton, and healthy infant, and not exclusively breastfeeding the infant (i.e., using formula or other foods in addition to breast milk)
Key exclusion criteria (1 listed)
- Having previously received mindfulness or similar training, having a diagnosed psychiatric disorder, and having any condition that impairs communication.
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 |
|---|---|---|
| Mindfulness-Based Breastfeeding Education GroupAlso: mindful breastfeeding groupA 4-week mindfulness-based breastfeeding education program was implemented, consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The intervention combined breastfeeding education with mindfulness-based stress reduction techniques, including breathing meditation, body scan meditation, sitting meditation, mountain meditation, and loving-kindness (Metta) meditation. Practical breastfeeding training was provided using a doll and breast model to support skill acquisition. Participants were also given audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice in addition to routine postpartum care. | Behavioural | Mindfulness-Based Breastfeeding Education Group |
Primary outcome
Mindful Breastfeeding Scale
Time frame: Baseline, 4th week postpartum, 4th month postpartum
This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period. The scale is unidimensional and was developed using a 5-point Likert scale. Responses to the scale items range from "always" to "never." The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.
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 15 Jun 2026.
- Results publicationKurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.
- Fırat University official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant confidentiality and in accordance with ethical approval and informed consent restrictions.
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 Mindfulness-Based Breastfeeding Education Group in people with Suboptimal Breastfeeding, run by Firat 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 1 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 15 Jun 2026. 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?
Mindful Breastfeeding Scale (time frame: Baseline, 4th week postpartum, 4th month postpartum). 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 NCT07647211, 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 15 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.