NCT07791121

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Progressive Muscle RelaxationKinesio TapingPremenstrual SymptomsPerceived StressDepressive SymptomsSleep QualityUniversity Students

Outcome Measures

Primary Outcomes (4)

  • Premenstrual Syndrome Scale

    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.

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

  • Perceived Stress Scale

    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.

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

  • Beck Depression Inventory

    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.

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

  • Pittsburgh Sleep Quality Index

    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.

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

Study Arms (4)

Progressive Muscle Relaxation Exercise

EXPERIMENTAL

Participants performed progressive muscle relaxation exercises for 8 weeks.

Behavioral: Progressive Muscle Relaxation Exercise

Kinesio Taping

EXPERIMENTAL

Participants received kinesio taping for 8 weeks

Device: Kinesio Taping

Progressive Muscle Relaxation Exercise and Kinesio Taping

EXPERIMENTAL

Participants received both progressive muscle relaxation exercise and kinesio taping for 8 weeks.

Behavioral: Progressive Muscle Relaxation ExerciseDevice: Kinesio Taping

Control

NO INTERVENTION

Participants received no study intervention and completed assessments at the same time points as the intervention groups.

Interventions

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.

Also known as: PMR
Progressive Muscle Relaxation ExerciseProgressive Muscle Relaxation Exercise and Kinesio Taping

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.

Also known as: KT
Kinesio TapingProgressive Muscle Relaxation Exercise and Kinesio Taping

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeDepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Aslı Er Korucu, Assistant Professor

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Füsun Terzioğlu, Professor

    Istanbul Aydın University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1:1:1 ratio to four groups representing progressive muscle relaxation exercise only, kinesio taping only, both interventions, or neither intervention (control). This 2 × 2 factorial design evaluated the individual and combined effects of the two interventions over 8 weeks, followed by a 1-month follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start

December 11, 2017

Primary Completion

August 2, 2018

Study Completion

August 2, 2018

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the associated publication will be shared upon approval of a reasonable request. The shared data may include baseline participant characteristics, intervention group assignment, and PMSS, PSS, BDI, and PSQI outcome scores collected at baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention. A data dictionary will also be provided. No directly or indirectly identifying participant information will be shared.

Shared Documents
STUDY PROTOCOL

Locations