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

• ClinicalTrials.gov Identifier: NCT03985579
• Recruitment Status: Unknown
• First Posted: June 13, 2019
• Last Update Posted: August 6, 2020
• Sponsor: Żelazna Medical Centre, LLC
• Information provided by (Responsible Party): Anna Jakóbik, Żelazna Medical Centre, LLC

Tracking Information

• First Submitted Date: June 5, 2019
• First Posted Date: June 13, 2019
• Last Update Posted Date: August 6, 2020
• Actual Study Start Date: July 1, 2019
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2019)

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

Original Primary Outcome Measures (submitted: June 12, 2019)

• 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 VAS scale
• 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
• 6 point self-rated breast engorgement scale [ Time Frame: assessment at the baseline ]
  assesment of breast engorgement
• 5 point perceived improvement scale [ Time Frame: assessment 24 hours after intervention ]
  assessment of improvement of signs and symptoms of breast engorgement
• The Breastfeeding Self-Efficacy Scale [ Time Frame: assessment at the baseline ]
  assessment of mother's attitude to breastfeeding

Current Secondary Outcome Measures (submitted: June 19, 2019)

• 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.
• 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
• 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

Original Secondary Outcome Measures (submitted: June 12, 2019)

• 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 VAS scale
• 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
• 5 point perceived improvement scale [ Time Frame: assessment 3 hours after intervention ]
  assessment of improvement of signs and symptoms of breast engorgement

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Lactation Disorders

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

Study Arms

• 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.
  Intervention: Other: Kinesiology taping application
• 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.

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 12, 2019): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2020
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT03985579
• Other Study ID Numbers: 24/2019
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Anna Jakóbik, Żelazna Medical Centre, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Żelazna Medical Centre, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dorota Sys, PhD; Centre of Postgraduate Medical Education

• PRS Account: Żelazna Medical Centre, LLC
• Verification Date: August 2020