跳至主要内容
临床试验/NCT03568370
NCT03568370Unknown不适用

Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions

National Defense Medical Center, Taiwan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Nipple trauma change

研究概览

简要总结

The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.

详细描述

Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Normal spontaneous delivery.
  • Pregnancy weeks between 37-
  • Single birth.
  • Initiated breastfeeding.

排除标准

  • Presence of crack in the nipple.
  • Medication applied to the nipple
  • The maternal health condition that may interfere with breastfeeding.
  • The infant with congenital abnormalities that would impair breastfeeding.
  • The infant attained low birth weight or other criteria to intensive care unit.

研究组 & 干预措施

breast milk

No Intervention

use breast milk on each nipple after each feeding

olive oil

Experimental

use one drop olive oil on each nipple after each feeding

干预措施: olive oil (Other)

结局指标

主要结局

Nipple trauma change

时间窗: Change from baseline nipple trauma at 10 days

use Nipple Trauma Score 0-5 point

Nipple sore change

时间窗: Change from baseline nipple pain at 10 days

use Nipple Soreness Score 0-5 point

Nipple pain change

时间窗: Change from baseline nipple pain at 10 days

use Numeric Rating Scale 0-10 point

breastfeeding duration

时间窗: 30 days

use Infant Feeding Categories

次要结局

  • Maternal satisfaction(baseline from Baseline nipple sore at 10 days)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin, Chen-xi

PI

National Defense Medical Center, Taiwan

研究点 (2)

Loading locations...

相似试验