The Effects of Kinesio Taping in Women With Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape application
Sham Kinesio tape application
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
- Ankara Yildirim Beyazit UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Kinesio tape group
Sham group
Control group
Arm Description
Kinesio tape application has been applied
Sham kinesio tape application has been applied
No intervention has been applied
Outcomes
Primary Outcome Measures
The severity of menstrual pain assessed with Visual Analog Scale
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.
Secondary Outcome Measures
The complaints related to menstruation will be evaluated by a form prepared by the researchers
The form assessing the complaints related to menstruation will be evaluated existing complaints affect the patient and expressed as, no, little, mederate, very.
The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory
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.
Full Information
NCT ID
NCT03915145
First Posted
April 10, 2019
Last Updated
April 12, 2019
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03915145
Brief Title
The Effects of Kinesio Taping in Women With Primary Dysmenorrhea
Official Title
Assistant Professor, Physioterapist, PhD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesio tape group
Arm Type
Experimental
Arm Description
Kinesio tape application has been applied
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham kinesio tape application has been applied
Arm Title
Control group
Arm Type
Other
Arm Description
No intervention has been applied
Intervention Type
Other
Intervention Name(s)
Kinesio tape application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham Kinesio tape application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
Primary Outcome Measure Information:
Title
The severity of menstrual pain assessed with Visual Analog Scale
Description
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.
Time Frame
An average of 2 weeks
Secondary Outcome Measure Information:
Title
The complaints related to menstruation will be evaluated by a form prepared by the researchers
Description
The form assessing the complaints related to menstruation will be evaluated existing complaints affect the patient and expressed as, no, little, mederate, very.
Time Frame
An average of 2 weeks
Title
The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory
Description
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.
Time Frame
An average of 2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda TOPRAK CELENAY
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Basak KAVALCI
Phone
+90-552-227-02-94
Email
kavalcibasak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Basak Kavalci
Organizational Affiliation
Gümüşhane Universıty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aysenur Karakus
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysenur Karakus
12. IPD Sharing Statement
Learn more about this trial
The Effects of Kinesio Taping in Women With Primary Dysmenorrhea
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