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Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:

Primary Purpose

Primary Dysmenorrhea, Kinesics, Aerobic Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiological taping
Aerobic exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, Kinesiological Taping, Aerobic Exercise

Eligibility Criteria

15 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being in the age range of 15-30
  • Not being married
  • Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale.
  • Women whose menstrual cycle has started and those whose cycle continues.

Exclusion Criteria:

  • Endometriosis and adenomyosis
  • Myoma
  • Endometrial polyp
  • Previous pelvic infections
  • Intrauterine device use
  • Venous congestion in the internal genital organs

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

The kinesiological taping (KT) group (n=15)

The aerobic exercise (AE) group (n=15)

The control group (n=15)

Arm Description

6 sessions of taping was applied to the kinesiological taping group, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. Using the KT ligament technique, it was applied to the supra pubic region with 100% tension in order to reduce contraction in the uterus

In the AE group, walking and climbing stairs were given during the menstrual cycle, 45 minutes session per day, 3 days a week over 3 weeks. The exercise protocol consists of 5 minute warm up, 35 min AE and 5 minute cool-down exercises. Warm-up and cool-down exercises include an active range of motion (ROM) exercises for upper and lower extremity. Aerobic exercise includes 30 min of moderate walking and climbing stairs. The aerobic exercise was performed in accordance with the definition of moderate-intensity exercise of the World Health Organization; "It was given to the participants that during moderate exercise, the individual should walk with a tempo in a way that he can speak but cannot sing"

No intervention was applied to the control group.

Outcomes

Primary Outcome Measures

Mcgill Pain Questionnaire
This questionnaire consists of 11 words to determine the sensory state of pain, and 15 words related to the quality of pain in total, consisting of 4 different words to determine its affective aspect. In addition, the pain intensity felt during measurement is measured by Visual analog Scale (VAS), and the total pain intensity assessed is measured by a 6-point Likert-type scale. In this scale, "0" is defined as no pain, "5" is defined as unbearable pain.
Menstrual Attitude Scale
The scale was prepared based on the theory that there may be versatility in menstrual attitudes, positive attitudes may occur as well as negative, and expectations that may occur according to physiological and emotional symptoms before or during menstruation may be effective in the behaviors shown in this period. Menstrual Attitude Scale (MAS) contains 33 items to measure the positive and negative attitudes of menstruation. MAS has 5 subscales such as the menstruation as a weakening phenomenon (12 no pain, unbearable pain, 32 items), the menstruation as a disturbing phenomenon (6 items), the menstruation as a natural phenomenon (5 items), the predicting/sensing that there will be menstruation (5 items), and the denying the effects of menstruation (7 items). The scale is of 5-point Likert type. The high average score of the subscales shows that the attitude towards menstruation is "positive"

Secondary Outcome Measures

Beck Depression Scale
It is a test containing 21 items that the person evaluates himself. It measures the symptoms seen in depression such as emotional, cognitive and motivational. The items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms. The total score of all answers is calculated as follows: 0 to 9 points: Minimally depressive symptoms 10 to 16 points: Mild depressive symptoms Between 17 and 29 points: Moderate depressive symptoms Between 30 and 63 points: Severe depressive symptoms
Short Form- 36
Short Form- 36 (SF-36) is a 36-question self-assessment scale consisting of eight subscales. This scale is based on physical function (10 items), role limitations due to physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100 and "0" indicates the lowest and "100" shows the best quality of life.

Full Information

First Posted
April 14, 2021
Last Updated
April 20, 2021
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04856280
Brief Title
Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:
Official Title
The Effects of Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
June 14, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. Kinesiological taping (KT) and aerobic exercise (AE) are effective methods for dysmenorrhea. The purpose of this study is to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Forty-five women with dysmenorrhea wıll randomly be divided into three groups as KT group (n=15), AE group (n=15) and control group (n=15). In KT Group, 6 sessions of KT will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. In the AE group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. No application will be applied to the control group. All groups will be evaluated with Beck Depression Scale (BDS), Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), and Short Form- 36 (SF-36) before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea, Kinesics, Aerobic Exercise
Keywords
Primary Dysmenorrhea, Kinesiological Taping, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor was blinded regarding group allocation.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The kinesiological taping (KT) group (n=15)
Arm Type
Experimental
Arm Description
6 sessions of taping was applied to the kinesiological taping group, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. Using the KT ligament technique, it was applied to the supra pubic region with 100% tension in order to reduce contraction in the uterus
Arm Title
The aerobic exercise (AE) group (n=15)
Arm Type
Active Comparator
Arm Description
In the AE group, walking and climbing stairs were given during the menstrual cycle, 45 minutes session per day, 3 days a week over 3 weeks. The exercise protocol consists of 5 minute warm up, 35 min AE and 5 minute cool-down exercises. Warm-up and cool-down exercises include an active range of motion (ROM) exercises for upper and lower extremity. Aerobic exercise includes 30 min of moderate walking and climbing stairs. The aerobic exercise was performed in accordance with the definition of moderate-intensity exercise of the World Health Organization; "It was given to the participants that during moderate exercise, the individual should walk with a tempo in a way that he can speak but cannot sing"
Arm Title
The control group (n=15)
Arm Type
No Intervention
Arm Description
No intervention was applied to the control group.
Intervention Type
Behavioral
Intervention Name(s)
Kinesiological taping
Intervention Description
In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes.
Primary Outcome Measure Information:
Title
Mcgill Pain Questionnaire
Description
This questionnaire consists of 11 words to determine the sensory state of pain, and 15 words related to the quality of pain in total, consisting of 4 different words to determine its affective aspect. In addition, the pain intensity felt during measurement is measured by Visual analog Scale (VAS), and the total pain intensity assessed is measured by a 6-point Likert-type scale. In this scale, "0" is defined as no pain, "5" is defined as unbearable pain.
Time Frame
4 weeks
Title
Menstrual Attitude Scale
Description
The scale was prepared based on the theory that there may be versatility in menstrual attitudes, positive attitudes may occur as well as negative, and expectations that may occur according to physiological and emotional symptoms before or during menstruation may be effective in the behaviors shown in this period. Menstrual Attitude Scale (MAS) contains 33 items to measure the positive and negative attitudes of menstruation. MAS has 5 subscales such as the menstruation as a weakening phenomenon (12 no pain, unbearable pain, 32 items), the menstruation as a disturbing phenomenon (6 items), the menstruation as a natural phenomenon (5 items), the predicting/sensing that there will be menstruation (5 items), and the denying the effects of menstruation (7 items). The scale is of 5-point Likert type. The high average score of the subscales shows that the attitude towards menstruation is "positive"
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Scale
Description
It is a test containing 21 items that the person evaluates himself. It measures the symptoms seen in depression such as emotional, cognitive and motivational. The items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms. The total score of all answers is calculated as follows: 0 to 9 points: Minimally depressive symptoms 10 to 16 points: Mild depressive symptoms Between 17 and 29 points: Moderate depressive symptoms Between 30 and 63 points: Severe depressive symptoms
Time Frame
4 weeks
Title
Short Form- 36
Description
Short Form- 36 (SF-36) is a 36-question self-assessment scale consisting of eight subscales. This scale is based on physical function (10 items), role limitations due to physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100 and "0" indicates the lowest and "100" shows the best quality of life.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
healthy young women who have primary dysmenorrhoea
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being in the age range of 15-30 Not being married Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale. Women whose menstrual cycle has started and those whose cycle continues. Exclusion Criteria: Endometriosis and adenomyosis Myoma Endometrial polyp Previous pelvic infections Intrauterine device use Venous congestion in the internal genital organs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miray BUDAK
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data not available due to ethical issues

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Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:

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