The Effect of Modified Pillow on Safety During Breastfeeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Breastfeeding Self-Efficacy Scale (BSES)
研究概览
简要总结
This study will investigate the effectiveness of a modified product "safe breastfeeding pillow" in enhancing the comfort and safety of postpartum women during breastfeeding. The results of this study can be used as a reference to promote clinical practice and education on breastfeeding to prolong the duration of breastfeeding and to ensure the safety of newborns.
详细描述
Breastfeeding has a significant long-term positive impact on the health, nutrition and development of children, as well as the physical and mental health of women. Baby-Friendly Hospital Initiative (BFHI) was launched by the World Health Organization and UNICEF in 1991 to encourage comfortable, supportive, and safe breastfeeding environments (Byrom et al., 2021). During breastfeeding, mothers need to maintain the same position with their hands for long periods of time, which can lead to muscle pain due to improper posture. In addition, postpartum fatigue can also lead to newborn fall accidents (Lipke et al., 2018).
Objective
To investigate the effectiveness of a modified pillow to enhance the comfort and safety of postpartum women during breastfeeding.
METHODS: A randomized controlled trial was conducted. Mothers and infants who gave birth naturally without serious postpartum complications at a university affiliate hospital will recruit in northern Taiwan. A questionnaire containing "Breastfeeding Self-Efficacy Scale (BSES)", "B-R-E-A-S-T-Feed scale", "Breastfeeding safety scale", and "Body Part Discomfort Scale (BPDS)" will be used to assess comfort and safety during breastfeeding.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal spontaneous delivered mothers without serious postpartum complications.
- •Normal newborns who can breastfeed.
- •The mother is willing to breastfeed at least 3 times in the cradle position during the hospital stay.
- •Mothers can communicate in Chinese and Taiwanese.
- •Agree to participate in the study and complete the informed consent form.
排除标准
- •Infants who cannot continue breastfeeding due to condition changes after birth.
- •Mothers who cannot continue breastfeeding due to medical reasons after childbirth.
结局指标
主要结局
Breastfeeding Self-Efficacy Scale (BSES)
时间窗: through study completion, an average of 2-7 days
A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence
次要结局
- Breastfeeding safety scale(through study completion, an average of 2-7 days)
- Body Part Discomfort Scale (BPDS)(through study completion, an average of 2-7 days)
- B-R-E-A-S-T-Feed scale(through study completion, an average of 2-7 days)