Effects of Kinesio Tape in Primary Dysmenorrhea

NCT ID: NCT06055049

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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: 28 students, sham The band applied: 28 students 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be 2 groups (kinesio taping and sham taping) and each group will consist of at least 28 people.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kinesio Taping (n=28)

Kinesio 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.

Group Type EXPERIMENTAL

Intervention (Kinesio Taping) group

Intervention Type OTHER

It is the group to which Kinesio Taping applied.

Sham Taping (n=28)

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.

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.

Group Type PLACEBO_COMPARATOR

Intervention (Kinesio Taping) group

Intervention Type OTHER

It is the group to which Kinesio Taping applied.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention (Kinesio Taping) group

It is the group to which Kinesio Taping applied.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,
* 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.

Exclusion Criteria

* 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,
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yağmur SÜRMELİ

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yağmur SÜRMELİ

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duygu VEFIKULUCAY YILMAZ, Prof

Role: STUDY_CHAIR

Mersin University Faculty of Nursing

Yagmur SURMELI, Lect.

Role: PRINCIPAL_INVESTIGATOR

Mersin University Faculty of Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mersin University

Mersin, Yenişehir, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Duygu VEFIKULUCAY YILMAZ, Prof

Role: CONTACT

+905054016268

Yagmur SURMELI, Lect.

Role: CONTACT

+905385701923

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Duygu Vefikuluçay Yılmaz, Prof

Role: primary

+905054016268

Yağmur Sürmeli, Lect.

Role: backup

+905385701923

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-41901325-200-57905 2023/016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Primary Dysmenorrhea and Mobilization.
NCT07314021 ACTIVE_NOT_RECRUITING NA
Pain Sensitivity During Puberty
NCT05145595 COMPLETED NA
Comparison of Two Different Fascial Treatments
NCT06715969 ENROLLING_BY_INVITATION NA