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

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ClinicalTrials.gov Identifier: NCT03985579
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Jakóbik, Żelazna Medical Centre, LLC

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.


Condition or disease Intervention/treatment Phase
Lactation Disorders Other: Kinesiology taping application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement at Early Lactation Stage.
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. The Breastfeeding Self‐Efficacy Scale [ Time Frame: assessment at the baseline ]
    assessment of mother's attitude to breastfeeding


Secondary Outcome Measures :
  1. Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention [ Time Frame: assessment at the baseline 3 hours after intervention ]
    Pain assesment by Visual Analogue Scale (VAS scale), range from 0-10, higher numbers represents worse outcome.

  2. Human milk outflow change from baseline till 3 hours after intervention [ Time Frame: assessment at the baseline and 3 hours after intervention ]
    Assesment of milk outflow based on infant body mass increase

  3. 5 point perceived improvement scale [ Time Frame: assessment 3 hours after intervention ]
    assessment of improvement of signs and symptoms of breast engorgement, range 1-5, higher values represent worse outcomes



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985579


Contacts
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Contact: Anna Jakóbik, MSc +48 501145348 a.jakobik@szpitalzelazna.pl

Locations
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Poland
Żelazna Medical Centre, St. Sophia Hospital Recruiting
Warsaw, Poland, 01-004
Contact: Anna Jakóbik, PT, MSc         
Sponsors and Collaborators
Żelazna Medical Centre, LLC
Investigators
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Study Chair: Dorota Sys, PhD Centre of Postgraduate Medical Education

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Responsible Party: Anna Jakóbik, Physiotherapist, Żelazna Medical Centre, LLC
ClinicalTrials.gov Identifier: NCT03985579     History of Changes
Other Study ID Numbers: 24/2019
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Signs and Symptoms
Lactation Disorders
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases