Lactation DisordersNCT03985579
Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement.
A study testing Kinesiology taping application in people with Lactation Disorders, run by Żelazna Medical Centre, LLC at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Lactation Disorders
- What is being tested?
- Kinesiology taping application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- age less than 18 and more than 45
- patients after extensive surgical breast intervention or having breast implants
- allergy to kinesiology taping
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Żelazna Medical Centre, St. Sophia Hospital
Warsaw, 01-004
Anna Jakóbik, PT, MSc
About this study
Official title: Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement at Early Lactation Stage.
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
- Lactation Disorders
- Being tested
- Kinesiology taping application
- Medical subject headings
- Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: assessment 24 hours after intervention
The Breastfeeding Self-Efficacy Scale
assessment of mother's attitude to breastfeeding
Measured: assessment at the baseline
Secondary outcomes (3)
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.
Measured: assessment at the baseline 3 hours after intervention
Human milk outflow change from baseline till 3 hours after intervention
Assesment of milk outflow based on infant body mass increase
Measured: assessment at the baseline and 3 hours after intervention
5 point perceived improvement scale
assessment of improvement of signs and symptoms of breast engorgement, range 1-5, higher values represent worse outcomes
Measured: assessment 3 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactation DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Jakóbik, Żelazna Medical Centre, LLC
- Investigators
- Dorota Sys, PhD, Study chair, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985579
- Sponsor's protocol ID
- 24/2019
- Status last verified
- Aug 2020
- First submitted
- 5 Jun 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32944940
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement at Early Lactation Stage.
- ClinicalTrials.gov ID
- NCT03985579
- Acronym / sponsor ID
- 24/2019
- Conditions
- Lactation Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care and Kinesiology taping Group | Experimental | Other: Kinesiology taping applicationApplication 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 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- age less than 18 and more than 45
- patients after extensive surgical breast intervention or having breast implants
- allergy to kinesiology taping
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiology taping applicationApplication 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 | Standard care and Kinesiology taping Group |
Primary outcome
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
3 secondary outcomes
Visual Analogue Scale (VAS) change from baseline till 3 hours after intervention
Time frame: assessment at the baseline 3 hours after intervention
Human milk outflow change from baseline till 3 hours after intervention
Time frame: assessment at the baseline and 3 hours after intervention
5 point perceived improvement scale
Time frame: assessment 3 hours after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 32944940Zakarija-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Sys, PhD study chair
Centre of Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology taping application in people with Lactation Disorders, run by Żelazna Medical Centre, LLC at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Jakóbik, MSc (+48 501145348, a.jakobik@szpitalzelazna.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) change from baseline till 24 hours after intervention (time frame: assessment at the baseline 24 hours after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.