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临床试验/NCT03985579
NCT03985579Unknown不适用

Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement at Early Lactation Stage.

Żelazna Medical Centre, LLC2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
6 point self-rated breast engorgement scale

研究概览

简要总结

The aim of the research is to asses the efficacy of kinesiology taping application in breast engorgement in early postpartum stage.

Kinesiology application will be performed by women's health physiotherapist. Patient's perceived improvement and milk outflow following application will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • cesarian section or vaginal delivery
  • delivery between 37 and 41 gestational week
  • signs and symptoms of breast engorgement (significant increase of breast between 2nd and 10th day postpartum, pain, obstructed milk outflow)
  • VAS 4 and more
  • volume of milk outflow less than 20ml
  • 6 point self-rated engorgement scale between 3 and 6

排除标准

  • age less than 18 and more than 45
  • patients after extensive surgical breast intervention or having breast implants
  • allergy to kinesiology taping

结局指标

主要结局

6 point self-rated breast engorgement scale

时间窗: assessment at the baseline

assesment of breast engorgement, range 1-6, higher values represent worse outcomes

Visual Analogue Scale (VAS) change from baseline till 24 hours after intervention

时间窗: assessment at the baseline 24 hours after intervention

Pain assesment by Visual Analogue Scale (VAS scale), range 0-10, higher numbers represents worse outcome.

The Breastfeeding Self-Efficacy Scale

时间窗: assessment at the baseline

assessment of mother's attitude to breastfeeding

Human milk outflow change from baseline till 24 hours after intervention

时间窗: assessment at the baseline and 24 hours after intervention

Assesment of milk outflow based on infant body mass increase

5 point perceived improvement scale

时间窗: assessment 24 hours after intervention

assessment of improvement of signs and symptoms of breast engorgement range 1-5, higher values represent worse outcomes

次要结局

  • Human milk outflow change from baseline till 3 hours after intervention(assessment at the baseline and 3 hours after intervention)
  • Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention(assessment at the baseline 3 hours after intervention)
  • 5 point perceived improvement scale(assessment 3 hours after intervention)

研究者

发起方
Żelazna Medical Centre, LLC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Jakóbik

Physiotherapist

Żelazna Medical Centre, LLC

研究点 (2)

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