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Completed

NCT Number: NCT07791121

Progressive Muscle Relaxation and Kinesio Taping for Premenstrual Syndrome

This randomized controlled trial evaluated the effects of progressive muscle relaxation exercise, kinesio taping, and their combined application on premenstrual symptoms, perceived stress, severity of depressive symptoms, and sleep quality among university students with premenstrual syndrome. Participants were randomly assigned to progressive muscle relaxation, kinesio taping, combined progressive muscle relaxation and kinesio taping, or a control group. The interventions were implemented for 8 weeks. Outcomes were assessed at baseline, immediately after the intervention, and 1 month after completion of the intervention.

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Key information

Conditions

Premenstrual Syndrome Behavior Behavioral Symptoms Depression Dyssomnias Menstruation Disturbances Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

About this study

This four-arm, parallel-group randomized controlled trial was conducted among students from 13 faculties of Ankara University who met the eligibility criteria for premenstrual syndrome. Eligible participants were randomly assigned in a 1:1:1:1 ratio, using faculty-stratified randomization, to progressive muscle relaxation exercise, kinesio taping, combined progressive muscle relaxation exercise and kinesio taping, or a control group.

The interventions were implemented over 8 weeks. Assessments were conducted at baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention. Premenstrual symptoms were assessed as the primary outcome. Perceived stress, depressive symptoms, and sleep quality were assessed as secondary outcomes.

A total of 180 participants were initially randomized, with 45 participants assigned to each group. During the first intervention cycle, 14 participants discontinued the study: 2 from the control group, 4 from the kinesio taping group, 5 from the progressive muscle relaxation group, and 3 from the combined intervention group. Fourteen additional eligible participants were subsequently enrolled and allocated to the corresponding groups using the same faculty-stratified approach. Therefore, the total number of unique enrolled participants was 194. A total of 180 participants, 45 in each group, completed all assessments and were included in the complete-case analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female university student enrolled in the second or third year of one of the participating faculties at Ankara University
  • Menstrual cycle length between 21 and 35 days
  • Premenstrual syndrome according to the Premenstrual Syndrome Scale
  • Residing in central Ankara
  • Volunteering to participate and providing written informed consent

Exclusion criteria

  • Receiving medical treatment for premenstrual syndrome
  • Having a mental health condition or receiving treatment for such a condition
  • Receiving treatment for insomnia
  • Having a dermatological condition, such as an allergy or psoriasis
  • Having undergone surgery involving the lumbar or abdominal region
  • Experiencing difficulty communicating in Turkish

Treatment and study plan

Progressive Muscle Relaxation Exercise

Behavioral

Participants received supervised progressive muscle relaxation exercise involving the sequential tensing and relaxing of 16 muscle groups together with deep-breathing techniques. Two consecutive 20-minute sessions were conducted at each visit, resulting in 40 minutes of exercise. The intervention was delivered twice weekly for 8 weeks, for a total of 16 visits, and was initiated after menstrual bleeding had ended.

Other names: PMR

Kinesio taping

Device

During the luteal phase, an 8-cm strip of kinesio tape was applied vertically along the lower abdominal midline, and a 10-cm strip was applied horizontally across the vertical strip. The middle sections were applied with 25% tension, whereas the ends were applied without tension. The tape was replaced every 4 days during the luteal phase over two menstrual cycles and was reapplied if it detached prematurely. Each application lasted approximately 15 minutes, including preparation and participant instruction.

Other names: KT

Primary outcomes

  1. Premenstrual Syndrome Scale

    Time frame: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention

    Premenstrual symptom severity was assessed using the 44-item Premenstrual Syndrome Scale (PMSS). Each item is scored from 1 to 5, yielding a total score ranging from 44 to 220. Higher scores indicate greater premenstrual symptom severity.

  2. Perceived Stress Scale

    Time frame: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention

    Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS). Each item is scored from 0 to 4, with seven positively worded items reverse-scored, yielding a total score ranging from 0 to 56. Higher scores indicate higher levels of perceived stress.

  3. Beck Depression Inventory

    Time frame: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention

    Depressive symptom severity was assessed using the 21-item Beck Depression Inventory (BDI). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. The inventory was used to assess symptom severity and not to establish a clinical diagnosis of depression.

  4. Pittsburgh Sleep Quality Index

    Time frame: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Seven component scores derived from 19 self-reported items are summed to yield a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score greater than 5 indicates poor sleep quality.

Sponsors and collaborators

Lead sponsor

ASLI ER KORUCU

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

The Effects of Progressive Muscle Relaxation Exercise and Kinesio Taping on Stress, Depression, and Sleep Quality in University Students With Premenstrual Syndrome: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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