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Breath-Based Yoga-Supported Breastfeeding Education in Primiparous Mothers

Study acronym: BYBSE
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: Mar 1, 2026 to Jun 1, 2026
    • Primary completion pushed from Sep 1, 2026 to Dec 1, 2026
    • Study completion pushed from Jan 1, 2027 to Jun 1, 2027
    • Study description shortened, about 239 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07435363
Lead Sponsor Sakarya University
Conditions
(from sponsor)
Breastfeeding, Perceived Insufficient Milk Supply
Related terms Breast Feeding
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov