Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women：A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Breast engorgement_self-rating scale
研究概览
简要总结
In this article, women were randomly assigned to the Breast Mask Containing Cabbage Leaves Extract group and Breast Mask without Cabbage Leaves Extract group, and the breast engorgement, pain, hardness, before and after each treatment were measured. At the end of the study breast mask user experience and continued breastfeeding were measured.
详细描述
Breast engorgement as the swelling and distention of breast, which is one of the most common problems often occurs 2-4 days after delivery, resulting in pain and fever, which reduces the intention of mothers to continue breastfeeding and causes to stop breastfeeding in the early postpartum period.
There are many conservative treatments for relieving breast engorgement. At present, there have been published studies on the application of medications, cold compresses, warm compresses, massages, gua sha and cabbage leaves compression to breast problems during lactation. Previous studies have shown that cabbage leaves compression can relieve the breast engorgement, pain, and hardness of postpartum women. However, safety concerns related to freshness, preservation, and residual pesticides must be considered when using cabbage leaves in a clinical setting. The purpose of this study was to examine whether breast mask containing cabbage leaves extract can improve breast engorgement, pain, and hardness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old.
- •Breastfeeding.
- •Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.
- •Able to read and understand Chinese.
排除标准
- •Stillbirth
- •Allergy to cabbage or sulfa.
- •lactation inhibitors agents used.
- •Fever symptoms (> 38 degrees Celsius), including: wound infection, upper respiratory tract infection, urinary tract infection.
- •Breast symptoms, including: nipple cracks, skin damage, breast abscesses, mastitis, Malignant tumors.
- •Postpartum complications, including: postpartum hemorrhage, amniotic fluid embolism or other diseases requiring close care.
研究组 & 干预措施
breast mask without cabbage leaves extract group
Apply a breast mask without cabbage leaves extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.
干预措施: Sham Comparator (Combination Product)
breast mask containing cabbage leaves extract group
Apply the breast mask containing cabbage leaf extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.
干预措施: Experimental: breast mask containing cabbage leaves extract group (Combination Product)
结局指标
主要结局
Breast engorgement_self-rating scale
时间窗: Day1, 2, 3
Total four items of breast engorgement, pain, hardness, and heat. There are eleven grades, a score of 0 represents no problem at all, and a score of 10 represents the most severe degree.
Breast hardness_Physiological measurements
时间窗: Day1,2,3.
NEUTONE TDM-Z2 durometer pressure gauge
次要结局
- Breast mask user experience(Day 3)
- Continued breastfeeding(Day 30)