Primary DysmenorrheaNCT07335926
Tele-Pilates for Primary Dysmenorrhea
A study testing Tele-Pilates Exercise program and standardized menstrual health education online in people with Primary Dysmenorrhea, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD). The intervention includes 16 supervised online Pilates sessions delivered over eight weeks. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Tele-Pilates Exercise program and standardized menstrual health education online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jul 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-35 years
- Regular menstrual cycles (28±7 days)
- VAS ≥5 for menstrual pain
- Diagnosed with primary dysmenorrhea
Who cannot join
- Secondary dysmenorrhea (e.g., endometriosis, fibroids)
- Pregnancy or use of intrauterine devices
- Significant comorbidities (e.g., spondylolisthesis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-Pilates for Primary Dysmenorrhea: A Randomized Controlled Trial on Pain, Symptoms, and Trunk Endurance
This randomized controlled trial investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD). The intervention includes 16 supervised online Pilates sessions delivered over eight weeks.
Read the detailed description
Primary dysmenorrhea is a prevalent gynecological condition characterized by painful menstruation. Exercise, particularly core stabilization and mind-body methods like Pilates, may improve both physical and psychological symptoms associated with PD. In this single-center RCT, 34 women aged 18-35 with PD were randomized to either a Tele-Pilates group or a control group. The Pilates group received supervised online sessions twice weekly for 8 weeks. Outcomes included pain severity (VAS), symptom burden (MSQ), functional impairment (FEMD), disability (Oswestry LBP Index), and trunk muscle endurance (McGill tests). Findings demonstrated significant improvements in the Pilates group across all domains.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Tele-Pilates Exercise program, standardized menstrual health education online
- Keywords
- tele-pilates, menstrual pain, muscle endurance
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Pilates Exercise programOther
The intervention consisted of a synchronous, supervised tele-Pilates exercise program delivered via video conferencing platforms twice per week for 8 weeks. Each session lasted approximately 50 minutes and followed clinical Pilates principles based on the APPI method. The program emphasized core activation, diaphragmatic breathing, pelvic alignment, and trunk stabilization through progressively structured movements. Real-time feedback from a physiotherapist ensured correct execution, adaptation to individual capacity, and consistent adherence. The exercise protocol also incorporated components such as pelvic floor activation, transversus abdominis training, and guided relaxation.
standardized menstrual health education onlineBehavioural
The education module consisted of two 45-minute interactive sessions conducted by a physiotherapist and covered the physiology of the menstrual cycle, pathophysiology of primary dysmenorrhea, common symptoms, and non-pharmacological management strategies. Content also included lifestyle modifications such as hydration, nutrition, physical activity, stress reduction techniques, and proper menstrual hygiene practices. Educational materials were adapted from current evidence-based guidelines and delivered using digital slides and discussion-based formats to promote participant engagement and understanding.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Pilates Group | Experimental | Participants received 16 synchronous tele-Pilates sessions over 8 weeks (twice per week). Exercises followed the APPI method including stretching, core strengthening, pelvic floor training, and breathing-focused control. Receives: Other: Tele-Pilates Exercise program; Behavioral: standardized menstrual health education online |
| Control Group | Active comparator | Participants received standardized menstrual health education online but no exercise intervention. Receives: Behavioral: standardized menstrual health education online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual pain severity
Menstrual pain severity was assessed using a 10 cm Visual Analog Scale, where participants marked the most intense pain experienced during their last menstrual cycle.
Measured: Change from baseline to post-intervention (8 weeks)
Secondary outcomes (6)
Menstrual symptom severity (Menstrual Symptom Questionnaire total score)
The Menstrual Symptom Questionnaire is a 24-item self-report measure assessing the severity of menstrual-related symptoms across emotional, physical, and pain domains; each item is rated on a 5-point Likert scale (1 = never to 5 = always), yielding a total score range of 24 to 120, where higher scores indicate worse symptom severity.
Measured: Change from baseline to post-intervention (8 weeks)
Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)
Functional and Emotional Measure of Dysmenorrhea (FEMD) is a 14-item self-report scale assessing the functional and emotional impact of dysmenorrhea, with each item rated on a 5-point Likert scale (1 = not at all similar to my situation to 5 = very similar to my situation), yielding a total score range of 14 to 70, where higher scores indicate greater functional and emotional impairment.
Measured: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: flexor muscles)
Endurance of trunk flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
Measured: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: extensor muscles)
Endurance of trunk extensor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
Measured: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: lateral flexor muscles)
Endurance of trunk lateral flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
Measured: Change from baseline to post-intervention (8 weeks)
Disability due to low back pain (Oswestry Index)
The Oswestry Disability Index was used to measure functional disability related to low back pain, commonly accompanied by dysmenorrhea, a 10-item scale. Each item is scored from 0 to 5, resulting in a total score range of 0 to 50, where higher scores indicate greater levels of disability and functional limitation.
Measured: Change from baseline to post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Apr 2024
- Primary completion15 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Atlas University
- Investigators
- Hilal DENİZOĞLU KÜLLİ, Principal investigator, İSTANBUL ATLAS ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335926
- Sponsor's protocol ID
- hilalbuse1
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Pilates for Primary Dysmenorrhea: A Randomized Controlled Trial on Pain, Symptoms, and Trunk Endurance
- ClinicalTrials.gov ID
- NCT07335926
- Acronym / sponsor ID
- hilalbuse1
- Conditions
- Primary Dysmenorrhea
- Keywords
- tele-pilates, menstrual pain, muscle endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Jan 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 investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD). The intervention includes 16 supervised online Pilates sessions delivered over eight weeks.
Detailed description
Primary dysmenorrhea is a prevalent gynecological condition characterized by painful menstruation. Exercise, particularly core stabilization and mind-body methods like Pilates, may improve both physical and psychological symptoms associated with PD. In this single-center RCT, 34 women aged 18-35 with PD were randomized to either a Tele-Pilates group or a control group. The Pilates group received supervised online sessions twice weekly for 8 weeks. Outcomes included pain severity (VAS), symptom burden (MSQ), functional impairment (FEMD), disability (Oswestry LBP Index), and trunk muscle endurance (McGill tests). Findings demonstrated significant improvements in the Pilates group across all domains.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Pilates Group | Experimental | Other: Tele-Pilates Exercise program, Behavioral: standardized menstrual health education onlineParticipants received 16 synchronous tele-Pilates sessions over 8 weeks (twice per week). Exercises followed the APPI method including stretching, core strengthening, pelvic floor training, and breathing-focused control. |
| Control Group | Active comparator | Behavioral: standardized menstrual health education onlineParticipants received standardized menstrual health education online but no exercise intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-35 years
- Regular menstrual cycles (28±7 days)
- VAS ≥5 for menstrual pain
- Diagnosed with primary dysmenorrhea
Key exclusion criteria (3 listed)
- Secondary dysmenorrhea (e.g., endometriosis, fibroids)
- Pregnancy or use of intrauterine devices
- Significant comorbidities (e.g., spondylolisthesis)
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 |
|---|---|---|
| Tele-Pilates Exercise programThe intervention consisted of a synchronous, supervised tele-Pilates exercise program delivered via video conferencing platforms twice per week for 8 weeks. Each session lasted approximately 50 minutes and followed clinical Pilates principles based on the APPI method. The program emphasized core activation, diaphragmatic breathing, pelvic alignment, and trunk stabilization through progressively structured movements. Real-time feedback from a physiotherapist ensured correct execution, adaptation to individual capacity, and consistent adherence. The exercise protocol also incorporated components such as pelvic floor activation, transversus abdominis training, and guided relaxation. | Other | Tele-Pilates Group |
| standardized menstrual health education onlineThe education module consisted of two 45-minute interactive sessions conducted by a physiotherapist and covered the physiology of the menstrual cycle, pathophysiology of primary dysmenorrhea, common symptoms, and non-pharmacological management strategies. Content also included lifestyle modifications such as hydration, nutrition, physical activity, stress reduction techniques, and proper menstrual hygiene practices. Educational materials were adapted from current evidence-based guidelines and delivered using digital slides and discussion-based formats to promote participant engagement and understanding. | Behavioural | Control Group, Tele-Pilates Group |
Primary outcome
Menstrual pain severity
Time frame: Change from baseline to post-intervention (8 weeks)
Menstrual pain severity was assessed using a 10 cm Visual Analog Scale, where participants marked the most intense pain experienced during their last menstrual cycle.
6 secondary outcomes
Menstrual symptom severity (Menstrual Symptom Questionnaire total score)
Time frame: Change from baseline to post-intervention (8 weeks)
Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)
Time frame: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: flexor muscles)
Time frame: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: extensor muscles)
Time frame: Change from baseline to post-intervention (8 weeks)
Trunk muscle endurance (McGill tests: lateral flexor muscles)
Time frame: Change from baseline to post-intervention (8 weeks)
Disability due to low back pain (Oswestry Index)
Time frame: Change from baseline to post-intervention (8 weeks)
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 13 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD).
Related trials for Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
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Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
Not yet recruiting
Whole-Body Vibration and Aerobic Exercise for Primary Dysmenorrhea in Young Adult Women
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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.
Hilal DENİZOĞLU KÜLLİ principal investigator
İSTANBUL ATLAS ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Pilates Exercise program and standardized menstrual health education online in people with Primary Dysmenorrhea, run by Atlas 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 4 inclusion and 3 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 13 Jan 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?
Menstrual pain severity (time frame: Change from baseline to post-intervention (8 weeks)). 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 13 Jan 2026.