BreastfeedingNCT06668467
The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply
A study testing Mindfulness-based Stress Reduction in people with Breastfeeding, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Mindfulness-based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2024to 30 May 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35
- 37 weeks or more of gestation
- Primipar
- Having given birth vaginally
- University Health Application and Research Center, Gynaecology and Obstetrics Clinic
- Having a single and healthy baby (no multiple pregnancy)
Show all 9Show fewer
- 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
- 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
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, 34668
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply: A Randomized Controlled Trial
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
Read the detailed description
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
The study is designed as a single-blind, randomised controlled trial. It will be conducted between November 2024 and January 2025 at the Zeynep Kamil Women and Children's Diseases Education and Research Hospital.
Power analysis using G*Power showed that at least 35 samples would be sufficient for 2 groups with an effect size of 0.5, 95% power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).
Eligible women were randomised to the intervention group (n=35) and the control group (n=35). Women allocated to the intervention group received the MBSR programme. MBSR was scheduled for 4 weekly sessions of 30 minutes each. The control group received routine hospital care but no other intervention during this period.
The pre-test data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions and the measurement tools used in the study. After one week and at the end of 4 weeks, the same measurement tools were used to collect post-test data.
Participants were given information about the MBSR programme and told how, for how long, and where they would practise. The online MBSR programme was completed by the participants in a specific way for each session (with mind, body and breathing exercises). The MBSR programme was delivered in this way for 4 weeks (eight sessions in total, two sessions per week). In addition, participants were given homework (audio recordings) to repeat the mindfulness meditation practices throughout the week (until the next session). At the end of the fourth week, the measures were administered again to participants who had attended all eight sessions and completed their homework, and post-test data were collected.
- Conditions
- Breastfeeding
- Being tested
- Mindfulness-based Stress Reduction
- Keywords
- Breastfeeding self-efficacy, Mindfulness, Insufficient milk, Social support, Stress
- 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 Stress ReductionBehavioural
An 4-week Mindfulness-based stress reduction training programme
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Women assigned to the experimental group will receive mindfulness-based stress reduction training for 4 weeks. Receives: Behavioral: Mindfulness-based Stress Reduction |
| Control | No intervention | Women assigned to the control group will receive routine postpartum care services provided in the same hospital's outpatient clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Breastfeeding Scale (MIND-BFS)
The Mindful Breastfeeding Scale (MIND-BFS) is a 9-item measurement tool that evaluates awareness-based breastfeeding practices in the postpartum period. The scale is one-dimensional and was developed as a 5-point Likert type. Responses to the scale items vary from (1) Always to (5) Never. The total score to be obtained from the scale is scored between 9-45, and as the total score obtained from the scale increases, the awareness rate of breastfeeding also increases.
Measured: Day 1, Day 7, Day 30 after delivery
Breastfeeding Self-Efficacy Scale
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.
Measured: Day 1, Day 7, Day 30 after delivery
Depression, Anxiety and Stress Scale (DASS-21)
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension
Measured: Day 1, Day 7, Day 30 after delivery
Multidimensional Scale of Perceived Social Support (MSPSS)
MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.
Measured: Day 1, Day 7, Day 30 after delivery
Insufficient Milk Perception Scale
The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high
Measured: Day 1, Day 7, Day 30 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start4 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 May 2025
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 Saglik Bilimleri UniversitesiThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya, Saglik Bilimleri Universitesi
- Investigators
- Leyla Kaya, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668467
- Sponsor's protocol ID
- 19.04.2023/59
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06668467
- Acronym / sponsor ID
- 19.04.2023/59
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding self-efficacy, Mindfulness, Insufficient milk, Social support, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 31 Oct 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 aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
Detailed description
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
The study is designed as a single-blind, randomised controlled trial. It will be conducted between November 2024 and January 2025 at the Zeynep Kamil Women and Children's Diseases Education and Research Hospital.
Power analysis using G*Power showed that at least 35 samples would be sufficient for 2 groups with an effect size of 0.5, 95% power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).
Eligible women were randomised to the intervention group (n=35) and the control group (n=35). Women allocated to the intervention group received the MBSR programme. MBSR was scheduled for 4 weekly sessions of 30 minutes each. The control group received routine hospital care but no other intervention during this period.
The pre-test data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions and the measurement tools used in the study. After one week and at the end of 4 weeks, the same measurement tools were used to collect post-test data.
Participants were given information about the MBSR programme and told how, for how long, and where they would practise. The online MBSR programme was completed by the participants in a specific way for each session (with mind, body and breathing exercises). The MBSR programme was delivered in this way for 4 weeks (eight sessions in total, two sessions per week). In addition, participants were given homework (audio recordings) to repeat the mindfulness meditation practices throughout the week (until the next session). At the end of the fourth week, the measures were administered again to participants who had attended all eight sessions and completed their homework, and post-test data were collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mindfulness-based Stress ReductionWomen assigned to the experimental group will receive mindfulness-based stress reduction training for 4 weeks. |
| Control | No intervention | –Women assigned to the control group will receive routine postpartum care services provided in the same hospital's outpatient clinics. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being between the ages of 18-35
- 37 weeks or more of gestation
- Primipar
- Having given birth vaginally
- University Health Application and Research Center, Gynaecology and Obstetrics Clinic
Key exclusion criteria (6 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
- There is an obstacle that prevents the baby from being with the mother or being in the neonatal intensive care unit
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 Stress ReductionAn 4-week Mindfulness-based stress reduction training programme | Behavioural | Experimental |
Primary outcome
Mindful Breastfeeding Scale (MIND-BFS)
Time frame: Day 1, Day 7, Day 30 after delivery
The Mindful Breastfeeding Scale (MIND-BFS) is a 9-item measurement tool that evaluates awareness-based breastfeeding practices in the postpartum period. The scale is one-dimensional and was developed as a 5-point Likert type. Responses to the scale items vary from (1) Always to (5) Never. The total score to be obtained from the scale is scored between 9-45, and as the total score obtained from the scale increases, the awareness rate of breastfeeding also increases.
Breastfeeding Self-Efficacy Scale
Time frame: Day 1, Day 7, Day 30 after delivery
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Day 1, Day 7, Day 30 after delivery
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Day 1, Day 7, Day 30 after delivery
MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.
Insufficient Milk Perception Scale
Time frame: Day 1, Day 7, Day 30 after delivery
The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high
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 11 Jul 2025.
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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.
Leyla Kaya, PhD principal investigator
Saglik Bilimleri Universitesi
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 Stress Reduction in people with Breastfeeding, run by Saglik Bilimleri Universitesi 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 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 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?
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: Day 1, Day 7, Day 30 after delivery). The study lists 5 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 11 Jul 2025.