Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Nipple crack change
研究概览
简要总结
In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing barrier and breast milk used in the first ten days of breastfeeding to prevent the formation of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women. Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no treatment-control).
详细描述
Current evidence-based guidelines report that the incidence of nipple cracks ranges between 34-96%. Nipple cracks generally occur in the first week after the birth and may continue in the following periods of breastfeeding. Nipple crack is the second most common reason to stop breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies has been expressed as extremely painful and terrible. It is known that breast milk, olive oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks, will successfully allow to continue breastfeeding. In this way, breastfeeding will not be interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months. Using non-pharmacological, effective and therapeutic methods will also have a positive effect to increase the rate of breastfeeding.
Studies in the literature cover the evaluation of the effectiveness of beeswax or beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an effective and sufficient material in preventing and healing nipple cracks.
In this study, it is planned to include 90 lactating women (30 women in each group) to meet the parametric test assumptions in the experimental and control groups (beeswax-containing barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the experimental and control groups will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being over 18 years old;
- •Normal spontaneous delivery.
- •Pregnancy weeks between 37-
- •Single birth.
- •Initiated breastfeeding.
- •Having given birth to a healthy, full-term child.
- •Newborn with no oral, palatal or maxillofacial abnormalities.
- •Not taking any medication, considering that drug use may cause nipple problems.
- •Being able to read and write.
- •Volunteering to participate in the study.
- •Not having contraindications for breastfeeding.
排除标准
- •Not approving to participate in the research.
- •Being a multipara.
- •Not breastfeeding within the first 24 hours.
- •Development of any breast problem: Mastitis, engorgement etc.
- •Taking newborn into intensive care.
- •Not sticking to the application.
- •Using another nipple crack preventing method during application.
- •Being allergic to beeswax.
结局指标
主要结局
Nipple crack change
时间窗: Change from baseline nipple crack at 10 days
Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases)
次要结局
- Severity of nipple pain change(Change from baseline severity of nipple pain at 10 days.)
研究者
Seda Serhatlioglu
Principal Investigator
Karabuk University