Clinical trial NCT06055049: Effects of Kinesio Tape in Primary Dysmenorrhea
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea Primary
Kinesio Taping
Pain
Stress
Sleep Quality
Quality of life
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 2 groups (kinesio taping and sham taping) and each group will consist of at least 28 people.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mcgill Pain Scale
timeFrame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).
measure: VAS pain scale
timeFrame: Pre-Study will be applied to determine compliance with the criteria.
measure: Menstrual Symptom Questionnaire
timeFrame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).
measure: Adaptation of the Perceived Stress Scale
timeFrame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).
measure: Pittsburgh Sleep Quality Index
timeFrame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).
measure: World Health Organization Quality of Life Scale Short Form
timeFrame: Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
affiliation: Mersin University Faculty of Nursing
name: Duygu VEFIKULUCAY YILMAZ, Prof
role: STUDY_CHAIR
affiliation: Mersin University Faculty of Nursing
name: Yagmur SURMELI, Lect.
role: PRINCIPAL_INVESTIGATOR
References: