Skip to main content
Clinical Trials/NCT03985579
NCT03985579
Unknown
Not Applicable

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

Żelazna Medical Centre, LLC1 site in 1 country60 target enrollmentStarted: July 1, 2019Last updated:

Overview

Phase
Not Applicable
Sponsor
Żelazna Medical Centre, LLC
Enrollment
60
Locations
1
Primary Endpoint
6 point self-rated breast engorgement scale

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

6 point self-rated breast engorgement scale

Time Frame: 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

Time Frame: 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

Time Frame: assessment at the baseline

assessment of mother's attitude to breastfeeding

Human milk outflow change from baseline till 24 hours after intervention

Time Frame: assessment at the baseline and 24 hours after intervention

Assesment of milk outflow based on infant body mass increase

5 point perceived improvement scale

Time Frame: assessment 24 hours after intervention

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Żelazna Medical Centre, LLC
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Jakóbik

Physiotherapist

Żelazna Medical Centre, LLC

Study Sites (1)

Loading locations...

Similar Trials