NCT03985579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

June 5, 2019

Last Update Submit

August 5, 2020

Conditions

Lactation Disorders

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

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

    assessment at the baseline 3 hours after intervention

  • Human milk outflow change from baseline till 3 hours after intervention

    assessment at the baseline and 3 hours after intervention

  • 5 point perceived improvement scale

    assessment 3 hours after intervention

Study Arms (2)

Standard care and Kinesiology taping Group

EXPERIMENTAL

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

Standard care Group

NO INTERVENTION

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

Interventions

Kinesiology taping applicationOTHER

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

Standard care and Kinesiology taping Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • point self-rated engorgement scale between 3 and 6

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Żelazna Medical Centre, St. Sophia Hospital

Warsaw, 01-004, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32944940DERIVED

MeSH Terms

Conditions

Lactation Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dorota Sys, PhD

    Centre of Postgraduate Medical Education

    STUDY CHAIR

Central Study Contacts

Anna Jakóbik, MSc

CONTACT

+48 501145348a.jakobik@szpitalzelazna.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 13, 2019

Study Start

July 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)