Breath-Based Yoga-Supported Breastfeeding Education in Primiparous Mothers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorSakarya University
About this 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
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Online Breastfeeding Education
BehavioralA 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 Program
BehavioralA 4-week breath-based postpartum yoga program delivered online twice weekly for 45-60 minutes, including guided breathing exercises and gentle postpartum-appropriate movements.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Experimental I (Breastfeeding education + yoga)Experimental treatment 2 interventions
Group B: Experimental II (Breastfeeding education)Experimental treatment 1 intervention
Group C: Control Group: Routine CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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).
Time frame
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).
Time frame
Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)Secondary outcomes
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).
Time frame
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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