Breath-Based Yoga-Supported Breastfeeding Education in Primiparous Mothers

NCT07435363 | Not Yet Recruiting

• 1 other identifier: BYBSE-2026-01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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 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 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.

Conditions

Breastfeeding; Perceived Insufficient Milk Supply

Keywords

breastfeeding; breastfeeding education; breastfeeding self-efficacy; perceived insufficient milk supply; yoga; breath-based yoga; primiparous mothers

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

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

Secondary Outcomes (1)

• State-Trait Anxiety Inventory (STAI) Scores

  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)

Study Arms (3)

Experimental I (Breastfeeding education + yoga)

EXPERIMENTAL

Mothers 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

Behavioral: Online Breastfeeding Education; Behavioral: Breath-Based Postpartum Yoga Program

Experimental II (Breastfeeding education)

EXPERIMENTAL

Mothers 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).

Behavioral: Online Breastfeeding Education

Control Group: Routine Care

NO INTERVENTION

Mothers 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.

Interventions

Online Breastfeeding Education BEHAVIORAL

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

Experimental I (Breastfeeding education + yoga); Experimental II (Breastfeeding education)

Breath-Based Postpartum Yoga Program BEHAVIORAL

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.

Experimental I (Breastfeeding education + yoga)

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Only individuals who self-identify as female are eligible to participate, as the study focuses on postpartum biological females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Sakarya University: lead

Related Publications (19)

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MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Dilek Menekse, Associate Professor

  Sakarya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Menekse, Associate Professor

CONTACT

+905543485913; dkose@sakarya.edu.tr

Seda Tecik, PhD Candidate

CONTACT

+905447160661; sedatecik@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will use a single-blind design. While participants and intervention providers will not be blinded due to the nature of the education and yoga sessions, the outcomes assessor (statistician) will be blinded to group allocation during data analysis to reduce assessment bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share