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临床试验/NCT06129344
NCT06129344终止不适用

Comparative Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Feasibility Pilot Study

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
1
主要终点
The Breast Enhancement Assessment Scale

研究概览

简要总结

In this article, women were randomly assigned to the manual lymphatic drainage group, therapeutic ultrasound group, and control group, and the breast pain, swelling hardness, and milk excretion before and after each treatment were measured.

详细描述

Breast engorgement as the swelling and distention of breast, which is one of the most common problems of postpartum of 3-8 days. At the same time, the congested blood vessels and tissue fluid will enter the surrounding tissues, resulting in the retention of tissue fluid and blood, resulting in interstitial fluid. In cases such as interstitial edema, the flow of milk is restricted.

There are many conservative treatments for relieving breast swelling. At present, there have been published studies on the application of ultrasound therapy and manual lymphatic drainage to breast problems during lactation. Previous studies have shown that manual lymphatic drainage and ultrasound therapy can significantly improve the pain, temperature, and firmness of breast engorgement. Manual lymphatic drainage and ultrasound therapy have been widely used in physical therapy, but there is little empirical evidence for manual lymphatic drainage on breast swelling. It is hoped that this empirical medical research method can be used to reduce the effect of breast pain caused by breast problems and improve breast milk. The purpose of this study was to examine whether manual lymphatic drainage and ultrasound therapy can improve breast pain, breast swelling, and increase the flow and volume of milk removed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Typically, participants are unaware whether they are receiving experimental treatment or a control (e.g., standard care). The researchers and medical staff are aware of the treatment allocation.

Due to medical ethics, if there is related breast pain and discomfort, the medical staff will still relieve the patient's breast pain.

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Over 20 years old
  • Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth
  • Able to read and understand Chinese
  • At least four points on the Breast Swelling Scale

排除标准

  • Autoimmune system problems
  • physical and mental health problems
  • Breast abscesses, mastitis
  • Breast implants
  • Cardiac pacemakers
  • Malignant tumors

结局指标

主要结局

The Breast Enhancement Assessment Scale

时间窗: Change from Baseline The Breast Enhancement Assessment Scale at 3day

There are six grades of breast swelling: grade 1: tender, the breast does not change; grade 2: slight change; grade 3: the breast feels thick without tenderness; grade 4: the breast feels thick and begins to pressure Pain; Grade 5: Thick breasts with obvious tenderness; Grade 6: Very hard and very painful.

The Visual Analogue Scale for Pain;VASP

时间窗: Change from Baseline The Visual Analogue Scale for Pain;VASP at 3day

Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

The Total Daily Milk Volume

时间窗: Change from Baseline The Total Daily Milk Volume at 3day

Total Daily Milk Volume was be recorded.

次要结局

  • Increase breastfeeding rates(3day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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