Premenstrual SyndromeNCT07791121
Progressive Muscle Relaxation and Kinesio Taping for Premenstrual Syndrome
A study testing Progressive Muscle Relaxation Exercise and Kinesio Taping in people with Premenstrual Syndrome, run by ASLI ER KORUCU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Progressive Muscle Relaxation Exercise and Kinesio Taping
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2017to 2 Aug 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Progressive Muscle Relaxation Exercise, Kinesio Taping
- Keywords
- Progressive Muscle Relaxation, Kinesio Taping, Premenstrual Symptoms, Perceived Stress, Depressive Symptoms, Sleep Quality, University Students
- Medical subject headings
- Premenstrual Syndrome, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExerciseBehavioural
Also called PMR
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.
Kinesio TapingDevice
Also called KT
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Exercise | Experimental | Participants performed progressive muscle relaxation exercises for 8 weeks. Receives: Behavioral: Progressive Muscle Relaxation Exercise |
| Kinesio Taping | Experimental | Participants received kinesio taping for 8 weeks Receives: Device: Kinesio Taping |
| Progressive Muscle Relaxation Exercise and Kinesio Taping | Experimental | Participants received both progressive muscle relaxation exercise and kinesio taping for 8 weeks. Receives: Behavioral: Progressive Muscle Relaxation Exercise; Device: Kinesio Taping |
| Control | No intervention | Participants received no study intervention and completed assessments at the same time points as the intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start11 Dec 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASLI ER KORUCU
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, ASLI ER KORUCU, Ankara University
- Investigators
- Aslı Er Korucu, Assistant Professor, Principal investigator, Ankara UniversityFüsun Terzioğlu, Professor, Study director, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791121
- Sponsor's protocol ID
- KA-171114
- Other IDs
- 2017/10-24
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07791121
- Acronym / sponsor ID
- KA-171114
- Conditions
- Premenstrual Syndrome
- Keywords
- Progressive Muscle Relaxation, Kinesio Taping, Premenstrual Symptoms, Perceived Stress, Depressive Symptoms, Sleep Quality, University Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- ASLI ER KORUCUUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Exercise | Experimental | Behavioral: Progressive Muscle Relaxation ExerciseParticipants performed progressive muscle relaxation exercises for 8 weeks. |
| Kinesio Taping | Experimental | Device: Kinesio TapingParticipants received kinesio taping for 8 weeks |
| Progressive Muscle Relaxation Exercise and Kinesio Taping | Experimental | Behavioral: Progressive Muscle Relaxation Exercise, Device: Kinesio TapingParticipants received both progressive muscle relaxation exercise and kinesio taping for 8 weeks. |
| Control | No intervention | –Participants received no study intervention and completed assessments at the same time points as the intervention groups. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation ExerciseAlso: PMRParticipants 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. | Behavioural | Progressive Muscle Relaxation Exercise, Progressive Muscle Relaxation Exercise and Kinesio Taping |
| Kinesio TapingAlso: KTDuring 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. | Device | Kinesio Taping, Progressive Muscle Relaxation Exercise and Kinesio Taping |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı Er Korucu, Assistant Professor principal investigator
Ankara University
Füsun Terzioğlu, Professor study director
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Exercise and Kinesio Taping in people with Premenstrual Syndrome, run by ASLI ER KORUCU 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 5 inclusion and 6 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 27 Aug 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. 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?
Premenstrual Syndrome Scale (time frame: Baseline, immediately after the 8-week intervention, and 1 month after completion of the intervention). The study lists 4 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 27 Aug 2026.