Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement.

Lactation Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03985579
• Other study ID #: 24/2019
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: Zelazna Medical Centre, LLC
• Contact: Anna Jakóbik, MSc
• Phone: +48 501145348
• Email: a.jakobik[@]szpitalzelazna.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lactation Disorders
• Signs and Symptoms

Intervention

Other:
• Kinesiology taping application
Application of elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability from athletic injuries and a variety of other physical disorders

Locations

Country	Name	City	State
Poland	Zelazna Medical Centre, St. Sophia Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) change from baseline till 24 hours after intervention	Pain assesment by Visual Analogue Scale (VAS scale), range 0-10, higher numbers represents worse outcome.	assessment at the baseline 24 hours after intervention
Primary	Human milk outflow change from baseline till 24 hours after intervention	Assesment of milk outflow based on infant body mass increase	assessment at the baseline and 24 hours after intervention
Primary	6 point self-rated breast engorgement scale	assesment of breast engorgement, range 1-6, higher values represent worse outcomes	assessment at the baseline
Primary	5 point perceived improvement scale	assessment of improvement of signs and symptoms of breast engorgement range 1-5, higher values represent worse outcomes	assessment 24 hours after intervention
Primary	The Breastfeeding Self-Efficacy Scale	assessment of mother's attitude to breastfeeding	assessment at the baseline
Secondary	Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention	Pain assesment by Visual Analogue Scale (VAS scale), range from 0-10, higher numbers represents worse outcome.	assessment at the baseline 3 hours after intervention
Secondary	Human milk outflow change from baseline till 3 hours after intervention	Assesment of milk outflow based on infant body mass increase	assessment at the baseline and 3 hours after intervention
Secondary	5 point perceived improvement scale	assessment of improvement of signs and symptoms of breast engorgement, range 1-5, higher values represent worse outcomes	assessment 3 hours after intervention