Menstrual PainNCT06530381
Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation on Menstrual Pain
A study testing Pilates Exercises With Face-to-Face and Pilates Exercises With Telerehabilitation in people with Menstrual Pain, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Menstrual Pain
- What is being tested?
- Pilates Exercises With Face-to-Face and Pilates Exercises With Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 10 Sep 2024
- 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
- People between the ages of 18-30 who have a continuing menstrual cycle.
- Women with menstrual pain VAS>5.
- People with regular menstrual cycles.
Who cannot join
- Being in menopause.
- Using birth control pills.
- Taking hormone therapy.
- Having exercise intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation Methods on Menstrual Pain
Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.
Read the detailed description
20 women experiencing severe pain during menstruation were randomized into two groups. The same exercise program is applied to 10 participants face-to-face, and to 10 participants via telerehabilitation. Exercises are applied for 6 weeks, 2 days a week. Visual Analog Scale (VAS) is used for pain assessment, SF-36 Short Form is used to assess quality of life, and Menstrual Attitude Scale is used to assess symptoms in the premenstrual/menstrual period. Evaluations are performed twice in total, before and after treatment. Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
- Conditions
- Menstrual Pain
- Being tested
- Pilates Exercises With Face-to-Face, Pilates Exercises With Telerehabilitation
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Exercises With Face-to-FaceOther
The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed face to face.
Pilates Exercises With TelerehabilitationOther
The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed as telerehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pilates Exercises Applied With Face-to-Face Receives: Other: Pilates Exercises With Face-to-Face |
| Group 2 | Experimental | Pilates Exercises Applied With Telerehabilitation Receives: Other: Pilates Exercises With Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is used for subjective assessment of pain. VAS scores are evaluated on a scale of 1-10. 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-8 indicates severe pain, and 9-10 indicates very severe and unbearable pain.Individuals with VAS>5 are included in the study.
Measured: at baseline and at week 6.
Short-Form 36 (SF-36)
The SF-36 scale is used for quality of life assessment. This scale basically includes 8 subject scales. Each subject title is scored between 0-100. The scale has positive scoring, as the score increases, the quality of life also increases.
Measured: at baseline and at week 6.
Menstrual Attitude Scale (MAS)
MAS is used to evaluate symptoms in the premenstrual/menstrual period. MAS consists of 5 main topics and a total of 33 sub-items. MAS is a scale that includes both positive and negative items.
Measured: at baseline and at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start10 Jun 2024
- Primary completion22 Jul 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Menstrual PainStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Şahin Altaç, Halic University
- Investigators
- Duygu Şahin Altaç, PT, MSc., Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530381
- Sponsor's protocol ID
- 28.07.2024-MÜ
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unsal A, Ayranci U, Tozun M, Arslan G, Calik E. Prevalence of dysmenorrhea and its effect on quality of life among a group of female university students. Ups J Med Sci. 2010 May;115(2):138-45. doi: 10.3109/03009730903457218.
PubMed 20074018Daley A. The role of exercise in the treatment of menstrual disorders: the evidence. Br J Gen Pract. 2009 Apr;59(561):241-2. doi: 10.3399/bjgp09X420301. No abstract available.
PubMed 19341553Kirthika S V, S S, G MK, S R, Rnv D, P SS. Comparing Pilates and Gym Ball Exercises for Primary Dysmenorrhea Management: An Empirical Study. Cureus. 2024 Apr 28;16(4):e59184. doi: 10.7759/cureus.59184. eCollection 2024 Apr.
PubMed 38807793
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation Methods on Menstrual Pain
- ClinicalTrials.gov ID
- NCT06530381
- Acronym / sponsor ID
- 28.07.2024-MÜ
- Conditions
- Menstrual Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 31 Jul 2024 (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.
Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.
Detailed description
20 women experiencing severe pain during menstruation were randomized into two groups. The same exercise program is applied to 10 participants face-to-face, and to 10 participants via telerehabilitation. Exercises are applied for 6 weeks, 2 days a week. Visual Analog Scale (VAS) is used for pain assessment, SF-36 Short Form is used to assess quality of life, and Menstrual Attitude Scale is used to assess symptoms in the premenstrual/menstrual period. Evaluations are performed twice in total, before and after treatment. Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Pilates Exercises With Face-to-FacePilates Exercises Applied With Face-to-Face |
| Group 2 | Experimental | Other: Pilates Exercises With TelerehabilitationPilates Exercises Applied With Telerehabilitation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- People between the ages of 18-30 who have a continuing menstrual cycle.
- Women with menstrual pain VAS>5.
- People with regular menstrual cycles.
Key exclusion criteria (4 listed)
- Being in menopause.
- Using birth control pills.
- Taking hormone therapy.
- Having exercise intolerance.
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 |
|---|---|---|
| Pilates Exercises With Face-to-FaceThe exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed face to face. | Other | Group 1 |
| Pilates Exercises With TelerehabilitationThe exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed as telerehabilitation. | Other | Group 2 |
Primary outcome
Visual Analog Scale (VAS)
Time frame: at baseline and at week 6.
VAS is used for subjective assessment of pain. VAS scores are evaluated on a scale of 1-10. 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-8 indicates severe pain, and 9-10 indicates very severe and unbearable pain.Individuals with VAS>5 are included in the study.
Short-Form 36 (SF-36)
Time frame: at baseline and at week 6.
The SF-36 scale is used for quality of life assessment. This scale basically includes 8 subject scales. Each subject title is scored between 0-100. The scale has positive scoring, as the score increases, the quality of life also increases.
Menstrual Attitude Scale (MAS)
Time frame: at baseline and at week 6.
MAS is used to evaluate symptoms in the premenstrual/menstrual period. MAS consists of 5 main topics and a total of 33 sub-items. MAS is a scale that includes both positive and negative items.
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 14 Mar 2025.
- Results publication: PubMed 20074018Unsal A, Ayranci U, Tozun M, Arslan G, Calik E. Prevalence of dysmenorrhea and its effect on quality of life among a group of female university students. Ups J Med Sci. 2010 May;115(2):138-45. doi: 10.3109/03009730903457218.
- Results publication: PubMed 19341553Daley A. The role of exercise in the treatment of menstrual disorders: the evidence. Br J Gen Pract. 2009 Apr;59(561):241-2. doi: 10.3399/bjgp09X420301. No abstract available.
- Results publication: PubMed 38807793Kirthika S V, S S, G MK, S R, Rnv D, P SS. Comparing Pilates and Gym Ball Exercises for Primary Dysmenorrhea Management: An Empirical Study. Cureus. 2024 Apr 28;16(4):e59184. doi: 10.7759/cureus.59184. eCollection 2024 Apr.
- Individual participant dataSharing planned: No
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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.
Duygu Şahin Altaç, PT, MSc. principal investigator
Halic 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 Pilates Exercises With Face-to-Face and Pilates Exercises With Telerehabilitation in people with Menstrual Pain, run by Halic University 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 3 inclusion and 4 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 14 Mar 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 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?
Visual Analog Scale (VAS) (time frame: at baseline and at week 6.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530381, which also lists 3 linked publications.
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 14 Mar 2025.