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

Primary Purpose

Lactation Disorders

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Kinesiology taping application

About this trial

This is an interventional supportive care trial for Lactation Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Żelazna Medical Centre, St. Sophia HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard care and Kinesiology taping Group

Standard care Group

Arm Description

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.

Assistance in baby feeding, manual of device-assisted (lactator) milk expression, cold compress, ibuprofen, gentle breast massage, breathing and shoulder girdle exercise.

Outcomes

Primary Outcome Measures

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.

Human milk outflow change from baseline till 24 hours after intervention

Assesment of milk outflow based on infant body mass increase

6 point self-rated breast engorgement scale

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

5 point perceived improvement scale

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

The Breastfeeding Self-Efficacy Scale

assessment of mother's attitude to breastfeeding

Secondary Outcome Measures

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.

Human milk outflow change from baseline till 3 hours after intervention

Assesment of milk outflow based on infant body mass increase

5 point perceived improvement scale

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

Full Information

NCT ID

NCT03985579

First Posted

June 5, 2019

Last Updated

August 5, 2020

Sponsor

Żelazna Medical Centre, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03985579

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Żelazna Medical Centre, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lactation Disorders

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care and Kinesiology taping Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard care Group

Arm Type

No Intervention

Arm Description

Assistance in baby feeding, manual of device-assisted (lactator) milk expression, cold compress, ibuprofen, gentle breast massage, breathing and shoulder girdle exercise.

Intervention Type

Other

Intervention Name(s)

Kinesiology taping application

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

assessment at the baseline 24 hours after intervention

Title

Human milk outflow change from baseline till 24 hours after intervention

Description

Assesment of milk outflow based on infant body mass increase

Time Frame

assessment at the baseline and 24 hours after intervention

Title

6 point self-rated breast engorgement scale

Description

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

Time Frame

assessment at the baseline

Title

5 point perceived improvement scale

Description

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

Time Frame

assessment 24 hours after intervention

Title

The Breastfeeding Self-Efficacy Scale

Description

assessment of mother's attitude to breastfeeding

Time Frame

assessment at the baseline

Secondary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention

Description

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

Time Frame

assessment at the baseline 3 hours after intervention

Title

Human milk outflow change from baseline till 3 hours after intervention

Description

Assesment of milk outflow based on infant body mass increase

Time Frame

assessment at the baseline and 3 hours after intervention

Title

5 point perceived improvement scale

Description

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

Time Frame

assessment 3 hours after intervention

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Jakóbik, MSc

Phone

+48 501145348

a.jakobik@szpitalzelazna.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorota Sys, PhD

Organizational Affiliation

Centre of Postgraduate Medical Education

Official's Role

Study Chair

Facility Information:

Facility Name

Żelazna Medical Centre, St. Sophia Hospital

City

Warsaw

ZIP/Postal Code

01-004

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Jakóbik, PT, MSc

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32944940

Citation

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.

Results Reference

derived

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

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