Premenstrual SyndromeNCT05836454
The Soft Tissue Mobilization Techniques on PMS
A study testing Progressive Muscle Relaxation Group: and Myofascial Release Technique Group in people with Premenstrual Syndrome and Premenstrual Pain, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Premenstrual Pain, Chronic Pelvic Pain
- What is being tested?
- Progressive Muscle Relaxation Group: and Myofascial Release Technique Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2022to 30 Jun 2025
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pain score of 4 cm or more according to the Visual Analogue Scale.
- Having a regular menstrual cycle for 12 months (24-35 days).
- According to the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the weekly Metabolic Equivalent of Task (MET) value is below 600 MET-min/week.
Who cannot join
- Those who have undergone surgery in the last 6 months,
- Those who use cigarettes and alcohol,
- Those who are pregnant,
- Those with urinary, genital, gastrointestinal disorders,
- Those who have had hysterectomy surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation Technique and Myofascial Release Technique on Premenstrual Symptoms, Blood Circulation, and Quality of Life in Women With Premenstrual Syndrome: a Single-blind Randomized Controlled Study
The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation.
Read the detailed description
The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. The study planned as a single-blind randomized controlled trial. The volunteers who were invited to the study and signed the voluntary consent form will be randomized via random allocation software to divided into 3 groups. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment will be done in the first 3 days of the first cycle, after first treatment acute assessment will be done. Post-treatment evaluation will be done in the first 3 days of the 3rd cycle after treatment for two cycles. Follow-up evaluation will be done in the first 3 days of the fifth cycle, two cycles after the post-treatment evaluation.
- Being tested
- Progressive Muscle Relaxation Group:, Myofascial Release Technique Group
- Keywords
- myofascial releasing technique, progressive relaxation technique, blood flow velocity
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation Group:Other
Progressive muscle relaxation is a relaxation technique that involves regular and sequential contraction and relaxation of muscles until the whole body is relaxed.
Myofascial Release Technique GroupOther
It is a physiotherapy technique based on soft tissue mobilization. All enveloping fascia sale prices are positive for mobility, a user used for adhesions and pain.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Group: | Experimental | Progressive Muscle Relaxation technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles. Receives: Other: Progressive Muscle Relaxation Group: |
| Myofascial Release Technique Group | Experimental | Myofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles. Receives: Other: Myofascial Release Technique Group |
| Control Group | No intervention | The control group will be asked to continue their normal lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Flow Rate at Two Menstrual Cycle
Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.
Measured: Baseline and 8 weeks
Follow- up Evaluation Blood Flow Rate
Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.
Measured: 8 weeks through study completion
Secondary outcomes (8)
Change from Baseline Pain Severity at Two Menstrual Cycle
It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the Visual Analogue Scale (VAS), a score of 0 indicates no pain, and 10 indicates unbearable pain.
Measured: Baseline and 8 weeks
Follow-up Evaluation Pain Severity at Two Menstrual Cycle
It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the VAS, a score of 0 indicates no pain, and 10 indicates unbearable pain.
Measured: 8 weeks through study completion
Change from Baseline Pain Threshold at Two Menstrual Cycle
It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.
Measured: Baseline and 8 weeks
Follow-up Evaluation Pain Threshold
It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.
Measured: 8 weeks through study completion
Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle
It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.
Measured: Baseline and 8 weeks
Follow-up Evaluation Premenstrual Syndrome
It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.
Measured: 8 weeks through study completion
Change From Baseline Health-related Quality of Life at Two Menstrual Cycle
It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.
Measured: Baseline and 8 weeks
Follow-up Evaluation Health-related Quality of Life
It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.
Measured: 8 weeks through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Sep 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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
- Single Blind Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Çisel Demiralp, Msc, Principal investigator, Eastern Meditteranean Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836454
- Sponsor's protocol ID
- PMSBloodFlow
- Status last verified
- May 2025
- First submitted
- 14 Mar 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Technique and Myofascial Release Technique on Premenstrual Symptoms, Blood Circulation, and Quality of Life in Women With Premenstrual Syndrome: a Single-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05836454
- Acronym / sponsor ID
- PMSBloodFlow
- Keywords
- myofascial releasing technique, progressive relaxation technique, blood flow velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 May 2023 (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.
The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation.
Detailed description
The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. The study planned as a single-blind randomized controlled trial. The volunteers who were invited to the study and signed the voluntary consent form will be randomized via random allocation software to divided into 3 groups. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment will be done in the first 3 days of the first cycle, after first treatment acute assessment will be done. Post-treatment evaluation will be done in the first 3 days of the 3rd cycle after treatment for two cycles. Follow-up evaluation will be done in the first 3 days of the fifth cycle, two cycles after the post-treatment evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single Blind Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Group: | Experimental | Other: Progressive Muscle Relaxation Group:Progressive Muscle Relaxation technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles. |
| Myofascial Release Technique Group | Experimental | Other: Myofascial Release Technique GroupMyofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles. |
| Control Group | No intervention | –The control group will be asked to continue their normal lives. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pain score of 4 cm or more according to the Visual Analogue Scale.
- Having a regular menstrual cycle for 12 months (24-35 days).
- According to the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the weekly Metabolic Equivalent of Task (MET) value is below 600 MET-min/week.
Key exclusion criteria (5 listed)
- Those who have undergone surgery in the last 6 months,
- Those who use cigarettes and alcohol,
- Those who are pregnant,
- Those with urinary, genital, gastrointestinal disorders,
- Those who have had hysterectomy surgery will be excluded.
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 Group:Progressive muscle relaxation is a relaxation technique that involves regular and sequential contraction and relaxation of muscles until the whole body is relaxed. | Other | Progressive Muscle Relaxation Group: |
| Myofascial Release Technique GroupIt is a physiotherapy technique based on soft tissue mobilization. All enveloping fascia sale prices are positive for mobility, a user used for adhesions and pain. | Other | Myofascial Release Technique Group |
Primary outcome
Change from Baseline Blood Flow Rate at Two Menstrual Cycle
Time frame: Baseline and 8 weeks
Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.
Follow- up Evaluation Blood Flow Rate
Time frame: 8 weeks through study completion
Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.
8 secondary outcomes
Change from Baseline Pain Severity at Two Menstrual Cycle
Time frame: Baseline and 8 weeks
Follow-up Evaluation Pain Severity at Two Menstrual Cycle
Time frame: 8 weeks through study completion
Change from Baseline Pain Threshold at Two Menstrual Cycle
Time frame: Baseline and 8 weeks
Follow-up Evaluation Pain Threshold
Time frame: 8 weeks through study completion
Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle
Time frame: Baseline and 8 weeks
Follow-up Evaluation Premenstrual Syndrome
Time frame: 8 weeks through study completion
Change From Baseline Health-related Quality of Life at Two Menstrual Cycle
Time frame: Baseline and 8 weeks
Follow-up Evaluation Health-related Quality of Life
Time frame: 8 weeks through study completion
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 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Premenstrual Syndrome
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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
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Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
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Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
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RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
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Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
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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.
Çisel Demiralp, Msc principal investigator
Eastern Meditteranean Univeristy
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 Group: and Myofascial Release Technique Group in people with Premenstrual Syndrome and Premenstrual Pain, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 inclusion and 5 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 16 Jul 2025. 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 Cyprus. 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?
Change from Baseline Blood Flow Rate at Two Menstrual Cycle (time frame: Baseline and 8 weeks). The study lists 2 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 16 Jul 2025.