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

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

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 Overview

• Status: Unknown
• Conditions: Lactation Disorders
• Intervention / Treatment: Other: Kinesiology taping application

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Jakóbik, MSc; Phone Number: +48 501145348; Email: a.jakobik@szpitalzelazna.pl

Study Locations

• Poland
  • Warsaw, Poland, 01-004
    • Recruiting
    • Żelazna Medical Centre, St. Sophia Hospital
    • Contact: Anna Jakóbik, PT, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard care and Kinesiology taping Group; 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.	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
No Intervention: Standard care Group; Assistance in baby feeding, manual of device-assisted (lactator) milk expression, cold compress, ibuprofen, gentle breast massage, breathing and shoulder girdle exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
6 point self-rated breast engorgement scale	assesment of breast engorgement, range 1-6, higher values represent worse outcomes	assessment at the baseline
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
The Breastfeeding Self-Efficacy Scale	assessment of mother's attitude to breastfeeding	assessment at the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC

Publications and helpful links

General Publications

• Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Lactation Disorders
• Other Study ID Numbers: 24/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No