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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Breastfeeding Self-Efficacy Score (BSES-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Intervention and Control Groups
- •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.
排除标准
- •for Intervention and Control Groups
- •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,
- •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.
研究组 & 干预措施
Experimental I (Breastfeeding education + yoga)
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
干预措施: Online Breastfeeding Education (Behavioral)
Experimental I (Breastfeeding education + yoga)
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
干预措施: Breath-Based Postpartum Yoga Program (Behavioral)
Experimental II (Breastfeeding education)
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).
干预措施: Online Breastfeeding Education (Behavioral)
Control Group: Routine Care
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.
结局指标
主要结局
Breastfeeding Self-Efficacy Score (BSES-SF)
时间窗: Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)
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).
Perceived Insufficient Milk Supply Scale
时间窗: Baseline (Postpartum Week 2), Second Measurement (Postpartum Week 5), and Final Measurement (Postpartum Week 9)
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).
次要结局
- 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))
研究者
dilek menekşe
Associate Professor
Sakarya University