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Primary DysmenorrheaNCT06055049

Effects of Kinesio Tape in Primary Dysmenorrhea

A study testing Intervention (Kinesio Taping) group in people with Primary Dysmenorrhea, run by Yağmur SÜRMELİ AKBAL at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this [study type: a single-blind, placebo-controlled randomization study] was to determine the effect of kinesio taping on pain, stress, sleep, and quality of life in college students with primary dysmenorrhea. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primary Dysmenorrhea
What is being tested?
Intervention (Kinesio Taping) group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2023to 30 Jun 2024
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • over 18 years old,
  • 1st grade student
  • Willing to participate in the research,
  • Open to communication,
  • Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
  • Menstrual pain severity is at least 4 according to the Visual Pain Scale,
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  • A score of 60 or more on the Menstruation Symptom Scale,
  • Not using hormonal contraception and intrauterine device,
  • Not pregnant and not experiencing pregnancy before,
  • Does not have a systemic and chronic disease,
  • Have not had a gynecological disorder or surgical operation before,
  • Not using analgesics 6 hours before and during the study period,
  • Not regularly applying kinesio taping,
  • Students without psychiatric problems.

Who cannot join

  • under the age of 18,
  • Studying in the 2nd grade,
  • Not willing to participate in the research,
  • Closed to communication,
  • Not having a regular menstrual period (not occurring at intervals of 21-35 days and lasting more or less than 3-8 days),
  • Menstrual pain severity is less than 4 according to the Visual Pain Scale,
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  • A score below 60 on the Menstruation Symptom Scale,
  • Using hormonal contraception and intrauterine device,
  • who are pregnant and have experienced pregnancy before,
  • Having a systemic and chronic disease,
  • Having had a gynecological disorder or surgical operation before,
  • Using analgesics 6 hours before and during the study period,
  • Regularly applying kinesio taping, Students with psychiatric problems.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University

    Mersin, Yenişehir, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Kinesio Taping on Pain, Stress, Sleep and Quality of Life in University Students With Primary Dysmenorrhea: A Randomized Controlled Study

The purpose of this [study type: a single-blind, placebo-controlled randomization study] was to determine the effect of kinesio taping on pain, stress, sleep, and quality of life in college students with primary dysmenorrhea. The key question(s) it aims to answer are:

  • [Is there a difference between pain, stress, sleep quality and quality of life scores in the post-kinesio taping intervention group and the placebo group?] Participants [both groups will come to the laboratory to replace their kinesio bands on the specified dates] If there is a comparison group: Researchers will compare with the placebo group.
Read the detailed description

The opinion of a biostatistician was taken to determine the population of volunteers in the study. As a result of this opinion, 1st year female students who enroll in Toros University Vocational School of Health Services in the 2023-2024 Fall Semester will form the universe of the research. The sample of the study consisted of 56 volunteers who were 18 years of age and older, who met the inclusion criteria, had a Visual Analog Scale (VAS) score of four and above, a Menstruation Symptom Scale score of 60 and above, and had primary dysmenorrhea (Kinesio tape applied: 31 students, sham The band applied: 31students will be formed After the female students to be included in the sample are determined, their assignments to the study and control groups will be made according to the randomization method. The research will start in the fall semester of the 2023-2024 academic year and the data collection period is planned as 4 months (25.09.2023-25.01.2024).

Before starting the application to the students in the study group, the researcher Y.S. Fast and easy application steps will be explained with the demonstration method, supported by visual presentations.

Kinesio Taping will be applied to the study group participants during three menstrual cycles. Kinesio taping will be done face to face by the researcher in the laboratory. The participants were given the "Mcgill Pain Scale Short Form", "Menstruation Symptom Scale", "Perceived Stress Scale", "Pittsburgh Sleep Quality Index" and "World Health Organization Quality of Life Scale-Short Form" immediately after the third cycle and the fourth cycle without treatment. -BREF-TR)" will be applied. The follow-up of the implementation process will be recorded with the MSF and KBIF prepared by the researcher.

Sham taping (fake or tensionless kinesio taping) will be applied to students in the placebo group. The quality of the kinesio tape used in sham taping will be the same. "Mcgill Pain Scale Short Form", "Menstruation Symptom Scale", "Perceived Stress Scale", "Pittsburgh Sleep Quality Index" and "World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR) administered to participants in the placebo group before the first session )" will be refilled at the end of the third cycle and at the end of the fourth cycle without treatment. In order to eliminate the ethical problems that may occur in the control group, kinesio taping will be applied to the participants in this group after the data collection process of the research is completed.

Being tested
Intervention (Kinesio Taping) group
Keywords
Dysmenorrhea Primary, Kinesio Taping, Pain, Stress, Sleep Quality, Quality of life
Medical subject headings
Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention (Kinesio Taping) groupOther

    It is the group to which Kinesio Taping applied.

Study groups in NCT06055049
Study groupRoleWhat they receive
Kinesio Taping (n=31)ExperimentalKinesio taping certified researcher Y.S. It will be implemented by. Kinesio Taping will be applied to the study group participants during three menstrual cycles. Kinesio taping will be done face to face by the researcher in the laboratory. The participants were given the "Mcgill Pain Scale Short Form", "Menstruation Symptom Scale", "Perceived Stress Scale", "Pittsburgh Sleep Quality Index" and "World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR) " immediately after the third cycle and the fourth cycle without treatment. will be applied. The follow-up of the implementation process will be recorded with the MSF and KBIF prepared by the researcher. Kinesio tapes will be applied to the sacral area with 100% tension twice a week, starting from the first start of menstruation. It will continue like this until the end of the 3rd period of menstruation.
Receives: Other: Intervention (Kinesio Taping) group
Sham Taping (n=31)Placebo comparatorSham taping (fake or tensionless kinesio taping) will be applied to students in the placebo group. The quality of the kinesio tape used in sham taping will be the same. "Mcgill Pain Scale Short Form", "Menstruation Symptom Scale", "Perceived Stress Scale", "Pittsburgh Sleep Quality Index" and "World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR) administered to participants in the placebo group before the first session )" will be refilled at the end of the third cycle and at the end of the fourth cycle without treatment. In order to eliminate the ethical problems that may occur in the control group, kinesio taping will be applied to the participants in this group after the data collection process of the research is completed. Kinesio tapes will be applied to the sacral area without tension, twice a week, starting from the first start of menstruation. This situation will continue until the end of the 3rd menstrual period.
Receives: Other: Intervention (Kinesio Taping) group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mcgill Pain Scale

    Mcgill Pain Scale Short Form (MAS-SF) The Mcgill Pain Scale Short Form was developed by Ronald Melzack in 1987 to determine the nature, effect, and overall pain intensity of pain.

    In the first part of the Mcgill Pain Scale Short Form, there are 15 word groups describing the sensory/perceptual pain dimension (first 11 words) and emotional/emotional pain dimension (last four words).

    In the second part of the scale, the severity of the pain at that moment is determined from the patient by using the VAS.

    In the third part of the scale, a six-point Likert type scale is used to determine the general pain intensity. Scale; It consists of expressive values ranging from 0 = no pain, 1 = mild, 2 = bothersome, 3 = distressing, 4 = terrible, 5 = unbearable pain.

    Measured: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  2. VAS pain scale

    Visual Analogue Scale (VAS)

    Different scales are used in studies to measure the level of pain. In our study, the pain intensity of the participants will be determined by using the Visual Analogue Scale (VAS) in the Determination of Compliance with the Criteria Form. VAS has been developed in order to be able to specify the severity of pain more easily by converting some values that cannot be measured numerically. VAS is a safe, easily applicable measurement tool that has been generally accepted in the world literature for many years. A low score on the VAS indicates low/low pain intensity, and a high score indicates high/severe pain.

    Measured: Pre-Study will be applied to determine compliance with the criteria.

  3. Menstrual Symptom Questionnaire

    Menstrual Symptom Questionnaire (MSQ) Menstruation Symptom Scale (MSI) It was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms . The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSÖ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The score obtained from the sub-dimensions in the scale is calculated by taking the total score average of the items in the sub-dimensions. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstrual symptoms related to that sub-dimension.

    Measured: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  4. Adaptation of the Perceived Stress Scale

    Adaptation of the Perceived Stress Scale (Pss-14) The Perceived Stress Level Scale was focused on by Cohen, Kamarck, and Mermelstein in 1983 to determine perceived stress controls. The Turkish validity and reliability study of the scale was conducted by Eskin et al. This 14-item scale reflects the extent to which people perceive purposive stress according to the basic idea in their lives. The scale is 5-point Likert type (0: Never, 1: Almost Never, 2: Sometimes, 3: Often, 4: Very Often). is a scale. One of the questions in the scale is to evaluate the changes in mood in the last month. There are seven items (4, 5, 6, 7, 9, 10 and 13) containing positive statements in the scale and these items are scored in reverse. The stress level perceived by the respondent is determined by adding the scores obtained from the items. A score between 0-56 points is taken in the scale. The higher the score, the higher the perceived stress level. The Cronbach Alpha Coefficient of the scale is 0.84.

    Measured: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  5. Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index (PUKI) PSQI assesses sleep quality over the past month. 19 out of 24 questions in PSQI are self-report questions. Five questions are answered by the spouse or roommate. The last five questions are for clinical information purposes only and are not included in the scoring. Self-report questions involve several factors related to sleep quality. These relate to the estimation of sleep duration, sleep latency, and the frequency and severity of certain sleep-related problems. Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction were divided into 18 items included in the scoring. Each item is evaluated over 0-3 points. As the total score obtained from the scale increases, sleep quality decreases. Patients with a total score of 0-4 on PUKI are classified as having good sleep quality. Scale scores of 5 and above indicate poor sleep quality.

    Measured: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  6. World Health Organization Quality of Life Scale Short Form

    World Health Organization Quality of Life Scale (WHOQOL-BREF-TR) The World Health Organization Quality of Life Scale-Short Form was developed by the World Health Organization (WHO) in 1998 to assess the quality of life of individuals. The Turkish validity and reliability studies of the scale were carried out by Eser et al. WHOQOL-BREF-TR consists of 27 questions and item 27 is not usually included in statistical analysis. The scale does not have a total score, each dimension is evaluated within itself. The scores of the dimensions are evaluated between 4-20. Increasing score indicates goodness.

    Measured: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start1 May 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

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
Model description
There will be 2 groups (kinesio taping and sham taping) and each group will consist of at least 31 people.
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055049
Sponsor's protocol ID
E-41901325-200-57905 2023/016
Status last verified
Oct 2026
First submitted
18 Sep 2023
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention (Kinesio Taping) group in people with Primary Dysmenorrhea, run by Yağmur SÜRMELİ AKBAL 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 14 inclusion and 13 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 22 Oct 2026. 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. Some participants in this study may receive a placebo. 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 Scale (time frame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).). The study lists 6 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 22 Oct 2026.

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