## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** 24/2019
#### Organization
**Class:** OTHER
**Full Name:** Żelazna Medical Centre, LLC
### Status Module
#### Completion Date
**Date:** 2020-12-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-08-06

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-07-01

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2019-06-13
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-05
**Study First Submit QC Date:** 2019-06-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Żelazna Medical Centre, LLC

#### Responsible Party

**Investigator Affiliation:** Żelazna Medical Centre, LLC

**Investigator Full Name:** Anna Jakóbik

**Investigator Title:** Physiotherapist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Lactation Disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: Kinesiology taping application

**Label:** Standard care and Kinesiology taping Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Standard care Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard care and Kinesiology taping Group

**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

**Name:** Kinesiology taping application

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

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

**Time Frame:** assessment at the baseline 24 hours after intervention

**Description:** Assesment of milk outflow based on infant body mass increase

**Measure:** Human milk outflow change from baseline till 24 hours after intervention

**Time Frame:** assessment at the baseline and 24 hours after intervention

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

**Measure:** 6 point self-rated breast engorgement scale

**Time Frame:** assessment at the baseline

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

**Measure:** 5 point perceived improvement scale

**Time Frame:** assessment 24 hours after intervention

**Description:** assessment of mother's attitude to breastfeeding

**Measure:** The Breastfeeding Self-Efficacy Scale

**Time Frame:** assessment at the baseline

#### Secondary Outcomes

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

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

**Time Frame:** assessment at the baseline 3 hours after intervention

**Description:** Assesment of milk outflow based on infant body mass increase

**Measure:** Human milk outflow change from baseline till 3 hours after intervention

**Time Frame:** assessment at the baseline and 3 hours after intervention

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

**Measure:** 5 point perceived improvement scale

**Time Frame:** assessment 3 hours after intervention

### Eligibility Module

**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

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** a.jakobik@szpitalzelazna.pl

**Name:** Anna Jakóbik, MSc

**Phone:** +48 501145348

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Warsaw

**Contacts:**

***Contact 1:***

- **Name:** Anna Jakóbik, PT, MSc

- **Role:** CONTACT

**Country:** Poland

**Facility:** Żelazna Medical Centre, St. Sophia Hospital

**Status:** RECRUITING

**Zip:** 01-004

#### Overall Officials

**Official 1:**

**Affiliation:** Centre of Postgraduate Medical Education

**Name:** Dorota Sys, PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 32944940

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M9991

- Name: Hyperemia

- Relevance: LOW

- As Found: Unknown

- ID: M10794

- Name: Lactation Disorders

- Relevance: HIGH

- As Found: Lactation Disorders

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007775

- Term: Lactation Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10102

- Name: Ibuprofen

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
