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BreastfeedingBYBSENCT07435363

Breath-Based Yoga-Supported Breastfeeding Education in Primiparous Mothers

A study testing Online Breastfeeding Education and Breath-Based Postpartum Yoga Program in people with Breastfeeding and Perceived Insufficient Milk Supply, run by Sakarya University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is designed as a randomized controlled trial (RCT) focused on improving breastfeeding outcomes among primiparous mothers in the postpartum period. Although the World Health Organization (WHO) recommends exclusive breastfeeding for the first six months as the ideal nutritional source for newborns, the rate… Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
What is being tested?
Online Breastfeeding Education and Breath-Based Postpartum Yoga Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 1 Jun 2027
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 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Primiparous mothers aged 19 years or older who delivered at term (37-42 weeks),
  • Mothers who gave birth in a Baby-Friendly Hospital in Sakarya,
  • Mothers who are open to communication and cooperation, voluntarily agree to participate in the study, and had a normal vaginal delivery,
  • Mothers who agree to participate in the study during postpartum weeks 0-2 and who will be in postpartum weeks 2-10 during the intervention period,
  • Mothers who breastfeed or practice mixed feeding,
  • Mothers and infants who are in good health,
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  • Mothers with a Body Mass Index within the normal range,
  • Mothers without sensory impairments such as hearing or vision problems,
  • Mothers without a diagnosed psychiatric history,
  • Mothers who can read and write in Turkish,
  • Mothers who score below 13 on the Edinburgh Postpartum Depression Scale (EPDS) at the first assessment.

Who cannot join

  • Infant loss,
  • Mothers with visual, auditory, or cognitive impairments,
  • Infants with physical disabilities or congenital anomalies,
  • Mothers with any neurological, orthopedic, or chronic condition that may prevent participation in exercise,
  • Mothers scoring 13 or above on the Edinburgh Postnatal Depression Scale (EPDS) at the first assessment,
  • Mothers who practiced yoga or breathing exercises during pregnancy or postpartum will be excluded,
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  • Since brief educational sessions provided before discharge in Baby-Friendly Hospitals are routine in Turkey, they will not be considered exclusion criteria.
  • However, mothers who received a structured breastfeeding education program during pregnancy or postpartum will be excluded from the study.
  • Withdrawal Criteria for Intervention and Control Groups
  • Participants who request to withdraw from the study at any time,
  • Participants who miss more than two yoga-breathing sessions, more than two breastfeeding education sessions, or who cannot be reached will be removed from the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dilek Menekse, Associate Professor contact

+905543485913 ext. +902642956613

dkose@sakarya.edu.tr

About this study

Official title: Effects of Breath-Based Yoga Supported Breastfeeding Education on Anxiety, Breastfeeding Self-Efficacy, and Perceived Insufficient Milk Supply in Primiparous Mothers: A Randomized Controlled Trial

This study is designed as a randomized controlled trial (RCT) focused on improving breastfeeding outcomes among primiparous mothers in the postpartum period. Although the World Health Organization (WHO) recommends exclusive breastfeeding for the first six months as the ideal nutritional source for newborns, the rate in Turkey (41% according to TDHS 2018) lags behind global targets (50-70%). Early cessation of breastfeeding is generally associated with mothers' inability to adapt to physical and psychological challenges. In particular, anxiety and stress experienced during the postpartum period lead to the development of a perceived insufficient milk supply, which negatively affects the acquisition of breastfeeding self-efficacy. In this context, this study investigates the potential of a supportive intervention facilitating stress management and relaxation on breastfeeding sustainability. Participants will be randomized into three groups: Intervention Group I (Online Breastfeeding Education + Breath-Based Yoga), Intervention Group II (Online Breastfeeding Education Only), and the Control Group (Routine Care). The interventions will be delivered remotely via Google Meet over a maximum period of seven weeks (3 weeks of breastfeeding education + 4 weeks of yoga practice). The primary objective of the study is to evaluate whether these structured interventions significantly improve maternal breastfeeding self-efficacy and reduce the perception of insufficient milk. Additionally, secondary outcomes will assess the impact on maternal anxiety levels. To ensure internal validity and isolate the intervention effect, mothers at high risk of postpartum depression (EPDS score > 13) are excluded from the study.

The Hypotheses of the Study

Read more

Each hypothesis will be tested independently:

H₀: The pre- and post-intervention measurement differences do not significantly differ between groups.

H₁: The pre- and post-intervention measurement differences significantly differ between groups (p < 0.05).

If a significant difference is detected, H₀ will be rejected and H₁ will be accepted. Multiple comparisons will be evaluated using the Holm-Bonferroni correction to control the Type I error rate.

  • H1a: Online breastfeeding education provided to primiparous mothers positively affects their anxiety levels.
  • H1b: Online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy.
  • H1c: Online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply.
  • H2a: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their anxiety levels.
  • H2b: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy.
  • H2c: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply.
Read the detailed description

Background Breast milk is the most ideal source of nutrition for newborns, due to its essential nutrients and bioactive components. The WHO recommends exclusive breastfeeding for the first six months, aiming for a rate of 50% by 2025 and 70% by 2030. Breast milk reduces morbidity and mortality related to infections, lowers the risk of chronic diseases, and supports neurodevelopment. It also has long-term protective effects for maternal health. However, exclusive breastfeeding rates are still below desired levels globally, ranging from 44-48%, and are 41% in Turkey. These low rates are associated with various factors, including maternal characteristics, birthing process, socioeconomic status, and access to health services.

Hormonal changes and sleep disturbances experienced during the postpartum period increase maternal anxiety, and breastfeeding difficulties are more common in primiparous mothers. Mothers are reported to require professional support in coping with problems and understanding infant behavior.

According to Bandura's Social Cognitive Theory, self-efficacy is an individual's belief in their capacity to successfully perform a specific task. Dennis's breastfeeding self-efficacy model shows that high self-efficacy is a determinant factor in initiating, continuing, and exclusively breastfeeding. Perceived insufficient milk supply is also a significant factor in early breastfeeding cessation. Problems such as pain, nipple trauma, and infant restlessness reinforce this perception. Low self-efficacy and perceived insufficient milk supply increase the need for formula supplementation. Kent et al. (2021) reported that 44% of mothers felt their milk supply was insufficient, leading 66% of them to provide formula. Therefore, WHO and UNICEF emphasize the importance of individual-needs-focused professional support for at-risk mothers.

Current breastfeeding education programs are reported to be insufficient in meeting the long-term needs of mothers, especially in the postpartum period, indicating a need for more comprehensive and holistic programs to increase breastfeeding self-efficacy. The literature suggests that while education increases self-efficacy and breastfeeding success, the sustainability of this effect needs to be strengthened. Digital platforms enhance the accessibility of breastfeeding counseling.

Yoga is a holistic practice based on breathing, stretching, and mindfulness, providing positive effects on stress, anxiety, and depression. Yoga practice during the prenatal and postnatal periods is reported to support physical and psychological well-being and reduce stress hormones. Findings also suggest that yoga practices in the postpartum period may have positive effects on milk production, oxytocin levels, and breastfeeding success.

Studies examining the relationship between yoga and breastfeeding in the national literature are limited. Arabacı (2024) demonstrated that yoga-breathing exercises had positive effects on breastfeeding success and self-efficacy. Boybay Koyuncu (2019) evaluated the effects of postpartum yoga on breastfeeding adequacy and maternal bonding. However, there is no study examining the effect of structured breastfeeding education based on the breastfeeding self-efficacy theory, integrated with breath-based yoga, on psychosocial outcomes such as anxiety and perceived insufficient milk supply.

Therefore, this randomized controlled trial aims to evaluate the effects of breath-based yoga supported breastfeeding education on anxiety, breastfeeding self-efficacy, and perceived insufficient milk supply in primiparous mothers. The intervention combines education based on the Breastfeeding Self-Efficacy Model with breath-based yoga practices, and its online delivery facilitates mothers' access to professional support. The study is expected to offer an innovative and holistic model for breastfeeding counseling and postpartum nursing care.

Methodology: This randomized controlled trial will be conducted to evaluate the effect of breath-based yoga supported breastfeeding education on anxiety, breastfeeding self-efficacy, and perceived insufficient milk supply in primiparous mothers during the postpartum period. The research will be carried out in Family Health Centers in the Sakarya province and will be reported according to the CONSORT 2025 guideline.

The study sample size was determined using the G*Power (v3.1) software for a three-group design. Based on the effect size ($Cohen's$ $f = 0.36$) obtained from a similar breastfeeding education study in the literature, the power analysis calculated that 26 participants per group would be sufficient, using parameters of $\alpha = 0.05$ and 1-$\beta = 0.80$. Considering a 15% increase for potential data losses, the final sample size is planned as a total of 90 participants, with 30 mothers in each group.

Primiparous mothers registered at the Family Health Centers, who are within 0-2 weeks postpartum and meet the inclusion criteria, will be enrolled. After informed consent and baseline assessments, mothers scoring below 13 points on the Edinburgh Postpartum Depression Scale will be included in the sample. The block randomization method will be preferred for assigning participants to the study and control groups. Following randomization, mothers will be assigned to Intervention Group I (breastfeeding education + yoga, n = 30), Intervention Group II (breastfeeding education only, n = 30), or the control group (n = 30). The randomization sequence will be generated by an independent statistician using a computer-based method and implemented via the opaque envelope method. Due to the nature of the intervention, participant blinding is not possible; analyses will be conducted by a blinded statistician.

Interventions and Timeline: The data collection tools for this study are the Introductory Information Form, BSES-SF, Perceived Insufficient Milk Supply Scale, STAI State-Trait Anxiety Inventory, and Edinburgh Postnatal Depression Scale (EPDS).

The interventions will be conducted online via Google Meet in small groups of 5, starting from the 2nd postpartum week (T1). The breastfeeding education program will consist of six synchronous sessions of 30-60 minutes each, held twice a week for three weeks. In the education + yoga group (Intervention I), breath-based yoga will be applied twice a week for 45-60 minutes for four weeks following the breastfeeding education. The control group will continue to receive routine Family Health Center services with no intervention. The same scales will be administered in all groups at T1 (2nd week), T2 (5th week), and T3 (9th week). The research will analyze changes over time and differences between groups to evaluate the effectiveness of the yoga-supported breastfeeding education.

Being tested
Online Breastfeeding Education, Breath-Based Postpartum Yoga Program
Keywords
breastfeeding, breastfeeding education, breastfeeding self-efficacy, perceived insufficient milk supply, yoga, breath-based yoga, primiparous mothers
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Breastfeeding EducationBehavioural

    A 3-week online breastfeeding education program delivered via Google Meet, twice weekly for 30-60 minutes, in small groups of five.

  • Breath-Based Postpartum Yoga ProgramBehavioural

    A 4-week breath-based postpartum yoga program delivered online twice weekly for 45-60 minutes, including guided breathing exercises and gentle postpartum-appropriate movements.

Study groups in NCT07435363
Study groupRoleWhat they receive
Experimental I (Breastfeeding education + yoga)ExperimentalMothers who meet the inclusion criteria and provide written informed consent will first complete the "Descriptive Information Form" and the "Edinburgh Postpartum Depression Scale (EPDS)." Mothers scoring below 13 on EPDS will be included in the study. Following randomization, mothers allocated to the Intervention I group will receive both breastfeeding education and breath-based yoga sessions. Participants will be organized into small groups of five, and a WhatsApp group will be created for each subgroup to facilitate communication and scheduling. Breastfeeding education will be delivered online via Google Meet twice weekly for 30-60 minutes over a three-week period by the researcher. After the completion of breastfeeding education, mothers will begin the breath-based yoga program. The yoga intervention will last four weeks and will be performed twice weekly for 45-60 minutes. Yoga sessions will include guided breathing exercises and gentle postpartum-appropriate movements. All necess
Receives: Behavioral: Online Breastfeeding Education; Behavioral: Breath-Based Postpartum Yoga Program
Experimental II (Breastfeeding education)ExperimentalMothers allocated to the Intervention II group will receive breastfeeding education only. Participants will be organized into small groups of five, and a WhatsApp group will be created for each subgroup. Breastfeeding education will be delivered online via Google Meet twice weekly for 30-60 minutes over a three-week period by the researcher. The educational content is identical to the content provided to the Intervention I group. No yoga intervention will be provided. Outcome measurements will be completed at postpartum week 2 (T1, before intervention), postpartum week 5 (T2, after completion of the education), and postpartum week 9 (T3, follow-up).
Receives: Behavioral: Online Breastfeeding Education
Control Group: Routine CareNo interventionMothers allocated to the Control Group will not receive any intervention (neither breastfeeding education nor yoga) within the scope of this study. Participants will continue to receive the routine standard care services provided by their Family Health Centers. Data collection will be carried out at the same time points as the intervention groups (postpartum week 2 [T1], week 5 [T2], and week 9 [T3]) during their routine check-ups at the Family Health Centers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breastfeeding Self-Efficacy Score (BSES-SF)

    Measured using the Breast-Feeding Self-Efficacy Scale-Short Form (BSES-SF). The BSES-SF is a 14-item, 5-point Likert scale (score range: 14 to 70). Higher scores indicate higher levels of breastfeeding self-efficacy. The aim is to detect significant differences in BSES-SF scores between the intervention and control groups across the three time points (T1, T2, T3).

    Measured: Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)

  2. Perceived Insufficient Milk Supply Scale

    Measured using the Perceived Insufficient Milk Supply Scale (PIMSS) a validated 6-item scale assessing mothers' perception of breast milk adequacy. The first item is answered yes/no, and the remaining items are scored from 0 to 10. Total scores range from 0 to 50, with lower scores indicating perceived milk insufficiency and higher scores indicating perceived adequacy. The aim is to detect significant differences in PIMSS scores between the intervention and control groups across the three time points (T1, T2, T3).

    Measured: Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)

Secondary outcomes (1)
  1. State-Trait Anxiety Inventory (STAI) Scores

    Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), which consists of two 20-item subscales: the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T). Both subscales are rated on a 4-point Likert scale. STAI-S measures anxiety experienced at the moment, whereas STAI-T reflects general and enduring anxiety tendencies. Total scores for each subscale range from 20 to 80, with higher scores indicating higher anxiety. The outcome includes changes in both STAI-S and STAI-T scores between the intervention and control groups across the three measurement points (T1, T2, T3).

    Measured: Postpartum Week 2 (T1), Week 5 (T2), Week 9 (T3)Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Randomized Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435363
Sponsor's protocol ID
BYBSE-2026-01
Acronym
BYBSE
Status last verified
Apr 2026
First submitted
20 Feb 2026
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy and confidentiality considerations.

Publications

  • Sharma H, Swetanshu, Singh P. Role of Yoga in Cardiovascular Diseases. Curr Probl Cardiol. 2024 Jan;49(1 Pt A):102032. doi: 10.1016/j.cpcardiol.2023.102032. Epub 2023 Aug 13.

    PubMed 37582455
  • Wood NK, Odom-Maryon T, Smart DA. Factors Associated with Perceived Insufficient Milk in the First Three Months of Breastfeeding. MCN Am J Matern Child Nurs. 2021 Jul-Aug 01;46(4):223-229. doi: 10.1097/NMC.0000000000000723.

    PubMed 34166240
  • Menekse D, Tiryaki O, Karakaya Suzan O, Cinar N. An investigation of the relationship between mother's personality traits, breastfeeding self-efficacy, and perception of insufficient milk supply. Health Care Women Int. 2021;42(4-6):925-941. doi: 10.1080/07399332.2021.1892114. Epub 2021 Apr 2.

    PubMed 33797343
  • Mohebati LM, Hilpert P, Bath S, Rayman MP, Raats MM, Martinez H, Caulfield LE. Perceived insufficient milk among primiparous, fully breastfeeding women: Is infant crying important? Matern Child Nutr. 2021 Jul;17(3):e13133. doi: 10.1111/mcn.13133. Epub 2021 Jan 5.

    PubMed 33399268
  • Mahurin-Smith J. Challenges with Breastfeeding: Pain, Nipple Trauma, and Perceived Insufficient Milk Supply. MCN Am J Matern Child Nurs. 2023 May-Jun 01;48(3):161-167. doi: 10.1097/NMC.0000000000000909.

    PubMed 37101329
  • Huang Y, Liu Y, Yu XY, Zeng TY. The rates and factors of perceived insufficient milk supply: A systematic review. Matern Child Nutr. 2022 Jan;18(1):e13255. doi: 10.1111/mcn.13255. Epub 2021 Aug 12.

    PubMed 34382733
  • Galipeau R, Dumas L, Lepage M. Perception of Not Having Enough Milk and Actual Milk Production of First-Time Breastfeeding Mothers: Is There a Difference? Breastfeed Med. 2017 May;12:210-217. doi: 10.1089/bfm.2016.0183. Epub 2017 Mar 22.

    PubMed 28326807
  • Mercan Y, Tari Selcuk K. Association between postpartum depression level, social support level and breastfeeding attitude and breastfeeding self-efficacy in early postpartum women. PLoS One. 2021 Apr 2;16(4):e0249538. doi: 10.1371/journal.pone.0249538. eCollection 2021.

    PubMed 33798229
  • Hines M, Hardy N, Martens A, Zimmerman E. Birth Order Effects on Breastfeeding Self-Efficacy, Parent Report of Problematic Feeding and Infant Feeding Abilities. J Neonatal Nurs. 2022 Feb;28(1):16-20. doi: 10.1016/j.jnn.2021.07.003. Epub 2021 Dec 21.

    PubMed 35095321
  • Gianni ML, Bettinelli ME, Manfra P, Sorrentino G, Bezze E, Plevani L, Cavallaro G, Raffaeli G, Crippa BL, Colombo L, Morniroli D, Liotto N, Roggero P, Villamor E, Marchisio P, Mosca F. Breastfeeding Difficulties and Risk for Early Breastfeeding Cessation. Nutrients. 2019 Sep 20;11(10):2266. doi: 10.3390/nu11102266.

    PubMed 31547061
  • Feenstra MM, Jorgine Kirkeby M, Thygesen M, Danbjorg DB, Kronborg H. Early breastfeeding problems: A mixed method study of mothers' experiences. Sex Reprod Healthc. 2018 Jun;16:167-174. doi: 10.1016/j.srhc.2018.04.003. Epub 2018 Apr 6.

    PubMed 29804762
  • Krol KM, Grossmann T. Psychological effects of breastfeeding on children and mothers. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Aug;61(8):977-985. doi: 10.1007/s00103-018-2769-0.

    PubMed 29934681
  • van der Kooij K, Te Pas SF. Perception of 3D Slant Out of the Box. Front Psychol. 2011 Jun 6;2:119. doi: 10.3389/fpsyg.2011.00119. eCollection 2011.

    PubMed 21713121
  • Espinosa E, Zamora P, Milla A, Morales S, Molina R, Mira M, Gonzalez Baron M; Oncopaz Cooperative Group. A phase II trial of cisplatin and vinorelbine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Head Neck. 2002 Dec;24(12):1054-9. doi: 10.1002/hed.10172.

    PubMed 12454943
  • Grolleau A, Bowman J, Pradet-Balade B, Puravs E, Hanash S, Garcia-Sanz JA, Beretta L. Global and specific translational control by rapamycin in T cells uncovered by microarrays and proteomics. J Biol Chem. 2002 Jun 21;277(25):22175-84. doi: 10.1074/jbc.M202014200. Epub 2002 Apr 9.

    PubMed 11943782

Questions about this trial

What is this clinical trial studying?

A study testing Online Breastfeeding Education and Breath-Based Postpartum Yoga Program in people with Breastfeeding and Perceived Insufficient Milk Supply, run by Sakarya University.

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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Dilek Menekse, Associate Professor (+905543485913 ext. +902642956613, dkose@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy Score (BSES-SF) (time frame: Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)). 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?

On the ClinicalTrials.gov record for NCT07435363, which also lists 19 linked publications.

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 28 Apr 2026.

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