Effects of Breast Tenderness Relief Intervention During the Late Pregnancy on the Parturients' Breast Engorgement, Lactation, Breastfeeding, Maternal Competence, and Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Parental Self-efficacy Scale
研究概览
简要总结
The study purpose is to examine the effects of breast tenderness relief intervention during the late pregnancy on the parturients' breast engorgement, lactation, breastfeeding, maternal competence, and stress.
详细描述
Background:
Maternal and child health is an important global health issue. Breast milk is the best food for infants and has many benefits for both mothers and infants. However, the breastfeeding rate in Taiwan has not increased but decreased in recent years. Breast engorgement and hypogalactia often cause distress for many women, and lead to stress and abandonment of breastfeeding, which in turn affects the achievement of motherhood. Therefore, nurses should provide support interventions for parturients early.
Methods:
This study is a two-years, prospective randomized controlled trial, and will adopt a longitudinal repeated-measures design. Convenience sampling will be used to recruit 180 pregnancy and postpartum women in the obstetrics clinic and postpartum ward of a medical center. The participants will be randomly assigned into two conditions (routine care and the breast tenderness relief intervention condition). The intervention will be provided to the participants from the 36th week of pregnancy until three months after delivery. Questionnaires, and biological measurements will be used to collect data. The outcome variables include the degree of breast engorgement, lactation, breastfeeding, maternal competencies, and stress. In addition, those data will be collected at the 36th and 38th week of pregnancy, three days, six weeks, and twelve weeks after childbirth. It is expected to analyze the research results with generalized estimation equation method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •1. Healthy pregnant women over 20 years old, without mental illness, and the number of pregnancy weeks has reached 36 weeks;
- •Full term production;
- •Literate or able to communicate in Chinese and Taiwanese;
- •After explaining, agree to participate in the research, sign the consent form, and accept long-term follower
排除标准
- •Pregnant women with a history of smoking, alcohol, and drug abuse;
- •Pregnant women have mental illness;
- •Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.;
- •Newborns with congenital abnormalities and major diseases;
- •Pregnant women who are unable or unwilling to breastfeed due to illness or other factors;
- •Refuse to accept breast compression intervention will be excluded from participating in the study
结局指标
主要结局
Parental Self-efficacy Scale
时间窗: Change from Baseline Parental self-efficacy at 12 weeks after delivery.
the late pregnancy on the parturients' maternal competence
The volume and speed of lactation
时间窗: Change from Baseline lactation at 12 weeks after delivery.
the late pregnancy on the parturients' lactation
Perceived Stress Scale
时间窗: Change from Baseline Perceived Stress Scale at 12 weeks after delivery.
late pregnancy on the parturients' stress
breast engorgement
时间窗: Change from Baseline breast engorgement at 12 weeks after delivery.
the late pregnancy on the parturients' breast engorgement
Breastfeeding Self-efficacy Scale Short Form
时间窗: Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
the late pregnancy on the parturients' breastfeeding
次要结局
未报告次要终点
研究者
Hsiang-Yun Lan
Associate Professor
National Defense Medical Center, Taiwan