- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915145
The Effects of Kinesio Taping in Women With Primary Dysmenorrhea
April 12, 2019 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
Assistant Professor, Physioterapist, PhD
The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Basak KAVALCI
- Phone Number: +90-552-227-02-94
- Email: kavalcibasak@gmail.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Ankara Yildirim Beyazit University
-
Contact:
- Aysenur Karakus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18 to 35 years of age,
- having Primary Dysmenorrhea
- being volunteer women
Exclusion Criteria:
- having give birth,
- having a serious psychiatric disorder
- having used oral contraceptive or depression drug in the last 6 month
- having secondary dysmenorrhea
- having irregular menstrual cycle
- having allergy to taping
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio tape group
Kinesio tape application has been applied
|
Kinesio tape application will be performed.Taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
|
Sham Comparator: Sham group
Sham kinesio tape application has been applied
|
Sham kinesio tape application will be performed.
Sham taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
|
Other: Control group
No intervention has been applied
|
The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The severity of menstrual pain assessed with Visual Analog Scale
Time Frame: An average of 2 weeks
|
A 10-cm Visual Analog Scale anchored from zero (no pain at all) to 10 (the worst pain I have ever felt) was used to determine the severity of each subject's menstrual pain.
|
An average of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The complaints related to menstruation will be evaluated by a form prepared by the researchers
Time Frame: An average of 2 weeks
|
The form assessing the complaints related to menstruation will be evaluated existing complaints affect the patient and expressed as, no, little, mederate, very.
|
An average of 2 weeks
|
The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory
Time Frame: An average of 2 weeks
|
The Spielberger State Trait Anxiety Inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.).
Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80.
A higher total score indicates more severe anxiety level.
|
An average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Basak Kavalci, Gümüşhane Universıty
- Study Chair: Aysenur Karakus, Ankara Yildirim Beyazıt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2019
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
April 10, 2019
First Submitted That Met QC Criteria
April 12, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 442-15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Dysmenorrhea
-
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