BreastfeedingNCT06252311
The Effect of Mindfulness-Based Breastfeeding Programme in Mothers After Cesarean Delivery
A study testing Mindfulness-Based Breastfeeding Programme in people with Breastfeeding, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
The study is a randomised controlled trial designed to determine the effect of the Mindfulness-Based Breastfeeding Programme on maternal breastfeeding awareness, breastfeeding attitudes and breastfeeding continuation among mothers who have given birth by caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Mindfulness-Based Breastfeeding Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 May 2025to 29 May 2026
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-40
- Having had a caesarean section at 37 weeks or more of gestation
- Having been hospitalised at Afyonkarahisar Health Sciences University Health Application and Research Center, Gynaecology and Obstetrics Clinic
- Having a single and healthy baby (no multiple pregnancy)
- Having completed at least primary school
- Being able to communicate in Turkish by phone using the WhatsApp application
- The baby is with the mother
Who cannot join
- Having a high-risk pregnancy
- Having a medical condition or taking medication that prevents breastfeeding
- Having a communication problems (vision, hearing, speech, language problems)
- Having a psychiatric illness
- Hysterectomy after caesarean section
- There is an obstacle that prevents the baby from being with the mother or being in the neonatal intensive care unit
- Having a condition/disease that prevents you from doing mindfulness practices (breathing exercises, body scanning)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Afyonkarahisar Health Sciences University Health Application and Research Center
Afyonkarahisar, Dörtyol, 03030
AFSU Health Research and Application Center
Afyonkarahisar, Merkez
About this study
Official title: The Effect of Mindfulness-Based Breastfeeding Programme on Breastfeeding Awareness and Breastfeeding Attitude in Mothers After Cesarean Delivery: A Randomised Controlled Study
The study is a randomised controlled trial designed to determine the effect of the Mindfulness-Based Breastfeeding Programme on maternal breastfeeding awareness, breastfeeding attitudes and breastfeeding continuation among mothers who have given birth by caesarean section. The study will evaluate the effectiveness of the Mindfulness-Based Breastfeeding programme using the "Mindful Breastfeeding Scale" and "Iowa Infant Feeding Attitude Scale". The research will use stratified and simple randomisation methods. Research data will be collected from mothers who gave birth by caesarean section at the gynaecology clinic of the Afyonkarahisar Health Sciences University Health Application and Research Center of between April 2024 and December 2025.
Read the detailed description
Breastfeeding is an ideal form of nutrition that has important implications for the health of mothers, infants and society. In addition to its beneficial effects on biopsychosocial health, it also contributes to social development in economic terms. Because of the powerful effects of breastfeeding, various studies, practices and guidelines have been organised for the initiation and maintenance of breastfeeding. World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first 6 months and continued breastfeeding with complementary foods until the age of 2 years. However, in Turkey, exclusive breastfeeding for the first 6 months is 41% and the median duration of breastfeeding is 16.7 months. Although most women are willing and able to breastfeed, there are several factors that affect the initiation and continuation of breastfeeding. Studies of the difficulties in initiating and maintaining breastfeeding may portray breastfeeding as primarily a challenging and demanding behaviour, rather than a reciprocal act that provides a positive emotional exchange for both infant and mother. Mindfulness-based breastfeeding involves focusing on the present moment and experiencing breastfeeding moment by moment. This approach is based on the idea that breastfeeding is a time for the mother and baby to relax and is a natural process. It is believed that mindfulness-based breastfeeding can have positive effects. While there are studies in the international literature on the effects of mindfulness practices during pregnancy on breastfeeding, mindfulness-based childbirth education interventions, transition to mindfulness-based motherhood, and the effects of mindfulness-based practices on maternal self-efficacy, no study has evaluated the effect of a mindfulness-based breastfeeding programme on breastfeeding attitude and awareness after a cesarean section. This randomised controlled study was planned to investigate the effect of a mindfulness-based structured breastfeeding programme on breastfeeding awareness and breastfeeding attitude after caesarean section. In order to determine the sample size, 70 experimental and 70 control groups were determined to be sufficient according to the power analysis performed by using the G*Power programme version 3.1 when the type-I error level (α)=0.05 and the power of the study was accepted as 0.90. Considering that women could not be provided with appropriate training due to pain and anaesthesia effect after caesarean section, sessions lasting 30 minutes were planned at hours when they felt comfortable and ready within 0-72 hours. The women in the experimental group will be trained a total of 6 sessions of mindfulness-based breastfeeding programme will be implemented, while the control group will be given rutin care. The research data will be collected by using Personal Information Form including sociodemographic characteristics, Iowa Infant Feeding Attitude Scale, Mindful Breastfeeding Scale and Infant Feeding Follow-up Form. As a result of the study, it is expected that breastfeeding awareness, breastfeeding attitude scores and breastfeeding continuity of the experimental group will be higher than the control group.
- Conditions
- Breastfeeding
- Being tested
- Mindfulness-Based Breastfeeding Programme
- Keywords
- Mindfulness, Breast Feeding, Attitude, Nursing
- Medical subject headings
- Breast Feeding, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Breastfeeding ProgrammeBehavioural
Mindfulness-Based Breastfeeding Programme will consist of structure and anatomy of the breast and milk production, breast milk content, benefits of breast milk, breast care, frequency and duration of breastfeeding, correct and comfortable position for breastfeeding, effects of stress on lactation hormones and milk production, World Health Organization guidelines on duration and continuity of breastfeeding, time to start complementary feeding general information on recommendations, General information about breastfeeding with awareness, mentioning its purpose and programme flow, and it includes formal and informal practices such as breathing awareness exercises, noticing the autopilot, lying/sitting meditation, body scanning exercises and mindful breastfeeding practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Breastfeeding Programme group | Experimental | Participants in the experimental group will receive the Mindfulness-Based Breastfeeding Programme, which consists of six 30-minute sessions within 0-72 hours. They will also be asked to complete a personal information form. In addition to the hospital sessions, educational materials, including home applications and audio recordings, will be sent via WhatsApp after discharge. During the first week after discharge, counselling will be provided by phone on the continuation of mindfulness-based practices, continuation of breastfeeding and problems related to breastfeeding, and referral to the health facility in case of problems, "Iowa Infant Feeding Attitude Scale" and "Mindful Breastfeeding Scale" will be administered by phone call in the 2nd month and finally the "Infant Feeding Follow-up Form" prepared by the researcher based on the literature will be used to assess the continuity of breastfeeding in the 1st week, 2nd month, 4th month and 6th month. Receives: Behavioral: Mindfulness-Based Breastfeeding Programme |
| Control group | No intervention | After the women in the control group have been informed about the study and have given their consent, they will complete a personal information form and then they will receive routine breastfeeding support and standard hospital care. The control group will be administered the Iowa Infant Feeding Attitude Scale and the Mindful Breastfeeding Scale by telephone interview at month 2 and the Infant Feeding Follow-up Form at week 1, month 2, month 4 and month 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Breastfeeding Scale (MIND-BFS)
Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding awareness in women who underwent cesarean section.
The Mindful Breastfeeding Scale (MIND-BFS), is a 9-item instrument that assesses mindfulness-based breastfeeding practice in the postpartum period. The scale is unidimensional and developed in 5-point Likert format. The answers to the scale items vary from (1) always (5) never. The total score obtained from the scale ranges from 9 to 45, and as the total score obtained from the scale increases, the level of breastfeeding awareness increases. The Cronbach's alpha value of the scale was found to be 0.83.
Measured: In the 2nd month after implementing the mindfulness-based breastfeeding program
Iowa Infant Feeding Attitude Scale (IIFAS)
Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding attitude in women who underwent caesarean section.
The Iowa Infant Feeding Attitude Scale (IIFAS) was to assess women's attitudes towards breastfeeding and predict the duration of breastfeeding and choice of infant feeding method. The scale comprises 17 items, each rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The scale includes 9 positive items about breastfeeding and 8 positive items about formula feeding, with the latter being reverse scored (1=5, 2=4, 4=2 and 5=1). The total attitude score ranges from 17 points (indicating a positive attitude towards bottle feeding) to 85 points (indicating a positive attitude towards breastfeeding).
Measured: In the 2nd month after implementing the mindfulness-based breastfeeding program
Secondary outcomes (1)
Infant Follow-up Form
Evaluation of the effect of mindfulness-based breastfeeding programme on the continuity of breastfeeding in women who underwent caesarean section. This is a 7-question form designed by the researcher to assess the continuity of breastfeeding at specific time intervals, including questions such as adequate weight gain of the baby, breastfeeding status and feeding method
Measured: 1st week, 2nd month, 4th month and 6th month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start11 May 2025
- Primary completion29 May 2026
- Study completion29 May 2026
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 Akdeniz 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
- Participants are assigned to one of two groups with a Mindfulness-Based Breastfeeding Programme and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife BUYUKOKUDAN, Akdeniz University
- Investigators
- Oznur KORUKCU, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252311
- Sponsor's protocol ID
- AkdenizU-HF-SB-01
- Status last verified
- May 2025
- First submitted
- 2 Feb 2024
- Last updated
- 26 Jun 2026
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Breastfeeding Programme on Breastfeeding Awareness and Breastfeeding Attitude in Mothers After Cesarean Delivery: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06252311
- Acronym / sponsor ID
- AkdenizU-HF-SB-01
- Conditions
- Breastfeeding
- Keywords
- Mindfulness, Breast Feeding, Attitude, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 11 May 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 9 Feb 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.
The study is a randomised controlled trial designed to determine the effect of the Mindfulness-Based Breastfeeding Programme on maternal breastfeeding awareness, breastfeeding attitudes and breastfeeding continuation among mothers who have given birth by caesarean section. The study will evaluate the effectiveness of the Mindfulness-Based Breastfeeding programme using the "Mindful Breastfeeding Scale" and "Iowa Infant Feeding Attitude Scale". The research will use stratified and simple randomisation methods. Research data will be collected from mothers who gave birth by caesarean section at the gynaecology clinic of the Afyonkarahisar Health Sciences University Health Application and Research Center of between April 2024 and December 2025.
Detailed description
Breastfeeding is an ideal form of nutrition that has important implications for the health of mothers, infants and society. In addition to its beneficial effects on biopsychosocial health, it also contributes to social development in economic terms. Because of the powerful effects of breastfeeding, various studies, practices and guidelines have been organised for the initiation and maintenance of breastfeeding. World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first 6 months and continued breastfeeding with complementary foods until the age of 2 years. However, in Turkey, exclusive breastfeeding for the first 6 months is 41% and the median duration of breastfeeding is 16.7 months. Although most women are willing and able to breastfeed, there are several factors that affect the initiation and continuation of breastfeeding. Studies of the difficulties in initiating and maintaining breastfeeding may portray breastfeeding as primarily a challenging and demanding behaviour, rather than a reciprocal act that provides a positive emotional exchange for both infant and mother. Mindfulness-based breastfeeding involves focusing on the present moment and experiencing breastfeeding moment by moment. This approach is based on the idea that breastfeeding is a time for the mother and baby to relax and is a natural process. It is believed that mindfulness-based breastfeeding can have positive effects. While there are studies in the international literature on the effects of mindfulness practices during pregnancy on breastfeeding, mindfulness-based childbirth education interventions, transition to mindfulness-based motherhood, and the effects of mindfulness-based practices on maternal self-efficacy, no study has evaluated the effect of a mindfulness-based breastfeeding programme on breastfeeding attitude and awareness after a cesarean section. This randomised controlled study was planned to investigate the effect of a mindfulness-based structured breastfeeding programme on breastfeeding awareness and breastfeeding attitude after caesarean section. In order to determine the sample size, 70 experimental and 70 control groups were determined to be sufficient according to the power analysis performed by using the G*Power programme version 3.1 when the type-I error level (α)=0.05 and the power of the study was accepted as 0.90. Considering that women could not be provided with appropriate training due to pain and anaesthesia effect after caesarean section, sessions lasting 30 minutes were planned at hours when they felt comfortable and ready within 0-72 hours. The women in the experimental group will be trained a total of 6 sessions of mindfulness-based breastfeeding programme will be implemented, while the control group will be given rutin care. The research data will be collected by using Personal Information Form including sociodemographic characteristics, Iowa Infant Feeding Attitude Scale, Mindful Breastfeeding Scale and Infant Feeding Follow-up Form. As a result of the study, it is expected that breastfeeding awareness, breastfeeding attitude scores and breastfeeding continuity of the experimental group will be higher than the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups with a Mindfulness-Based Breastfeeding Programme and control group
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Breastfeeding Programme group | Experimental | Behavioral: Mindfulness-Based Breastfeeding ProgrammeParticipants in the experimental group will receive the Mindfulness-Based Breastfeeding Programme, which consists of six 30-minute sessions within 0-72 hours. They will also be asked to complete a personal information form. In addition to the hospital sessions, educational materials, including home applications and audio recordings, will be sent via WhatsApp after discharge. During the first week after discharge, counselling will be provided by phone on the continuation of mindfulness-based practices, continuation of breastfeeding and problems related to breastfeeding, and referral to the health facility in case of problems, "Iowa Infant Feeding Attitude Scale" and "Mindful Breastfeeding Scale" will be administered by phone call in the 2nd month and finally the "Infant Feeding Follow-up Form" prepared by the researcher based on the literature will be used to assess the continuity of breastfeeding in the 1st week, 2nd month, 4th month and 6th month. |
| Control group | No intervention | –After the women in the control group have been informed about the study and have given their consent, they will complete a personal information form and then they will receive routine breastfeeding support and standard hospital care. The control group will be administered the Iowa Infant Feeding Attitude Scale and the Mindful Breastfeeding Scale by telephone interview at month 2 and the Infant Feeding Follow-up Form at week 1, month 2, month 4 and month 6. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being between the ages of 18-40
- Having had a caesarean section at 37 weeks or more of gestation
- Having been hospitalised at Afyonkarahisar Health Sciences University Health Application and Research Center, Gynaecology and Obstetrics Clinic
- Having a single and healthy baby (no multiple pregnancy)
- Having completed at least primary school
Key exclusion criteria (7 listed)
- Having a high-risk pregnancy
- Having a medical condition or taking medication that prevents breastfeeding
- Having a communication problems (vision, hearing, speech, language problems)
- Having a psychiatric illness
- Hysterectomy after caesarean section
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 ProgrammeMindfulness-Based Breastfeeding Programme will consist of structure and anatomy of the breast and milk production, breast milk content, benefits of breast milk, breast care, frequency and duration of breastfeeding, correct and comfortable position for breastfeeding, effects of stress on lactation hormones and milk production, World Health Organization guidelines on duration and continuity of breastfeeding, time to start complementary feeding general information on recommendations, General information about breastfeeding with awareness, mentioning its purpose and programme flow, and it includes formal and informal practices such as breathing awareness exercises, noticing the autopilot, lying/sitting meditation, body scanning exercises and mindful breastfeeding practice. | Behavioural | Mindfulness-Based Breastfeeding Programme group |
Primary outcome
Mindful Breastfeeding Scale (MIND-BFS)
Time frame: In the 2nd month after implementing the mindfulness-based breastfeeding program
Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding awareness in women who underwent cesarean section. The Mindful Breastfeeding Scale (MIND-BFS), is a 9-item instrument that assesses mindfulness-based breastfeeding practice in the postpartum period. The scale is unidimensional and developed in 5-point Likert format. The answers to the scale items vary from (1) always (5) never. The total score obtained from the scale ranges from 9 to 45, and as the total score obtained from the scale increases, the level of breastfeeding awareness increases. The Cronbach's alpha value of the scale was found to be 0.83.
Iowa Infant Feeding Attitude Scale (IIFAS)
Time frame: In the 2nd month after implementing the mindfulness-based breastfeeding program
Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding attitude in women who underwent caesarean section. The Iowa Infant Feeding Attitude Scale (IIFAS) was to assess women's attitudes towards breastfeeding and predict the duration of breastfeeding and choice of infant feeding method. The scale comprises 17 items, each rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The scale includes 9 positive items about breastfeeding and 8 positive items about formula feeding, with the latter being reverse scored (1=5, 2=4, 4=2 and 5=1). The total attitude score ranges from 17 points (indicating a positive attitude towards bottle feeding) to 85 points (indicating a positive attitude towards breastfeeding).
1 secondary outcome
Infant Follow-up Form
Time frame: 1st week, 2nd month, 4th month and 6th month after birth
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 26 Jun 2026.
- 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.
Oznur KORUKCU principal investigator
Akdeniz University
2 sites 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 Programme in people with Breastfeeding, run by Akdeniz University at 2 sites 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 7 inclusion and 7 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 26 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 2 sites 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 (MIND-BFS) (time frame: In the 2nd month after implementing the mindfulness-based breastfeeding program). 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 26 Jun 2026.