Primary DysmenorrheaNCT04856280
Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:
A study testing Kinesiological taping and Aerobic exercise in people with Primary Dysmenorrhea and Kinesics, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Kinesics, Aerobic Exercise
- What is being tested?
- Kinesiological taping and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2019to 20 Jul 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Endometriosis and adenomyosis
- Myoma
- Endometrial polyp
- Previous pelvic infections
- Intrauterine device use
- Venous congestion in the internal genital organs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
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.
- Conditions
- Primary Dysmenorrhea, Kinesics, Aerobic Exercise
- Being tested
- Kinesiological taping, Aerobic exercise
- Keywords
- Primary Dysmenorrhea, Kinesiological Taping, Aerobic Exercise
- Medical subject headings
- Kinesics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiological tapingBehavioural
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.
Aerobic exerciseBehavioural
In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| The kinesiological taping (KT) group (n=15) | Experimental | 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 Receives: Behavioral: Kinesiological taping |
| The aerobic exercise (AE) group (n=15) | Active comparator | 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" Receives: Behavioral: Aerobic exercise |
| The control group (n=15) | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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"
Measured: 4 weeks
Secondary outcomes (2)
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
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start22 Nov 2019
- Primary completion14 Jun 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mbudak, Istanbul Medipol University Hospital
- Investigators
- Miray BUDAK, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856280
- Sponsor's protocol ID
- KinesioExercisePD2021
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data not available due to ethical issues
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04856280
- Acronym / sponsor ID
- KinesioExercisePD2021
- Conditions
- Primary Dysmenorrhea, Kinesics, Aerobic Exercise
- Keywords
- Primary Dysmenorrhea, Kinesiological Taping, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 23 Apr 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The kinesiological taping (KT) group (n=15) | Experimental | Behavioral: Kinesiological taping6 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 |
| The aerobic exercise (AE) group (n=15) | Active comparator | Behavioral: Aerobic exerciseIn 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" |
| The control group (n=15) | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Endometriosis and adenomyosis
- Myoma
- Endometrial polyp
- Previous pelvic infections
- Intrauterine device use
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 |
|---|---|---|
| Kinesiological tapingIn 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. | Behavioural | The kinesiological taping (KT) group (n=15) |
| Aerobic exerciseIn the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes. | Behavioural | The aerobic exercise (AE) group (n=15) |
Primary outcome
Mcgill Pain Questionnaire
Time frame: 4 weeks
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
Time frame: 4 weeks
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"
2 secondary outcomes
Beck Depression Scale
Time frame: 4 weeks
Short Form- 36
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No. Data not available due to ethical issues
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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.
Miray BUDAK study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiological taping and Aerobic exercise in people with Primary Dysmenorrhea and Kinesics, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mcgill Pain Questionnaire (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.