Dysmenorrhea PrimaryNCT06615258
The Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life
A study testing Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training and Pelvic floor muscle training in people with Dysmenorrhea Primary and Pain Management, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Pain Management, Diaphragmatic Breathing
- What is being tested?
- Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training and Pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Mar 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-35,
- Voluntary participation,
- Having a regular menstrual cycle (every 24-35 days) ,
- Menstrual pain intensity of 3/10 or higher on the Visual Analog Scale during the initial assessment,
- Pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation,
- Restriction of daily living activities due to pain,
- Requirement for medical intervention or self-medication to control the pain.
Who cannot join
- History of pelvic pathology and/or surgery that could cause pain,
- Neurological or psychological disorders,
- Anovulation,
- Other diseases that could affect chest expansion or the respiratory system (COPD, asthma, pneumonia, bronchiectasis, etc.),
- Being pregnant, having a positive birth control status, or being less than 6 months postpartum,
- Use of an intrauterine device,
- History of childbirth or miscarriage. Individuals who miss two consecutive exercise sessions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: Investigation of the Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life in Women With Primary Dysmenorrhea: A Randomized-Controlled Trial
Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. In secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. Other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. Empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. Recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. Thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure .
Within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with PD.
- Conditions
- Dysmenorrhea Primary, Pain Management, Diaphragmatic Breathing, Pelvic Floor Muscle Exercise
- Being tested
- Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training, Pelvic floor muscle training
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle trainingBehavioural
DNS-based breathing exercises will be taught to the women in this group using tactile biofeedback. To create tactile stimulation, one of the hard sponges placed within a belt will be positioned anteriorly in the inguinal region, and the other posteriorly in the Grynfeltt-Lesshaft triangle region. Breathing training will be provided in 3 different positions: sitting, crawling, and happy baby pose.
Pelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises.
Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position.
Pelvic floor muscle trainingBehavioural
Pelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises. Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position.
| Study group | Role | What they receive |
|---|---|---|
| DNS Based breathing exercises+PFMT | Experimental | Dynamic Neuromuscular Stabilization (DNS)-based respiratory training and pelvic floor muscle training (PFMT) will be applied. Receives: Behavioral: Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training |
| PFMT | Active comparator | Pelvic floor muscle training (PFMT) will be applied. Receives: Behavioral: Pelvic floor muscle training |
| Control Group | No intervention | No intervention will be made to the participants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Menstruation Symptom Scale score
Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.
Measured: 4 weeks after the intervention
Change in the McGill pain questionnaire score
The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.
Measured: 4 weeks after the intervention
Secondary outcomes (4)
Change of Menstruation Symptom Scale score
Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.
Measured: 3 months after the intervention
Change of Quality of Life score
Short Form-36 is a 36-question self-assessment scale consisting of eight subscales. This scale consists of physical function (10 items), role limitations (physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" indicating the lowest and "100" indicating the best quality of life level.
Measured: 4 weeks after the intervention
Change in the McGill pain questionnaire score
The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.
Measured: 3 months after the intervention
Change of Quality of Life score
Short Form-36 is a 36-question self-assessment scale consisting of eight subscales. This scale consists of physical function (10 items), role limitations (physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" indicating the lowest and "100" indicating the best quality of life level.
Measured: 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615258
- Sponsor's protocol ID
- SYY_3
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yakit Yesilyurt S, Birinci Olgun T, Dag Y, Donmez EN, Aytekin I, Erkanli ME, Budak A. Effect of pelvic floor muscle training with or without dynamic neuromuscular stabilization-based breathing on menstrual pain and symptoms of primary dysmenorrhea: a randomized controlled trial. BMC Womens Health. 2026 Jun 11. doi: 10.1186/s12905-026-04578-w. Online ahead of print.
PubMed 42271328
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life in Women With Primary Dysmenorrhea: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT06615258
- Acronym / sponsor ID
- SYY_3
- Conditions
- Dysmenorrhea Primary, Pain Management, Diaphragmatic Breathing, Pelvic Floor Muscle Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 26 Sep 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.
Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. In secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. Other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. Empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. Recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. Thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure .
Within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DNS Based breathing exercises+PFMT | Experimental | Behavioral: Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle trainingDynamic Neuromuscular Stabilization (DNS)-based respiratory training and pelvic floor muscle training (PFMT) will be applied. |
| PFMT | Active comparator | Behavioral: Pelvic floor muscle trainingPelvic floor muscle training (PFMT) will be applied. |
| Control Group | No intervention | –No intervention will be made to the participants in this group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 18-35,
- Voluntary participation,
- Having a regular menstrual cycle (every 24-35 days) ,
- Menstrual pain intensity of 3/10 or higher on the Visual Analog Scale during the initial assessment,
- Pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation,
Key exclusion criteria (7 listed)
- History of pelvic pathology and/or surgery that could cause pain,
- Neurological or psychological disorders,
- Anovulation,
- Other diseases that could affect chest expansion or the respiratory system (COPD, asthma, pneumonia, bronchiectasis, etc.),
- Being pregnant, having a positive birth control status, or being less than 6 months postpartum,
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 |
|---|---|---|
| Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle trainingDNS-based breathing exercises will be taught to the women in this group using tactile biofeedback. To create tactile stimulation, one of the hard sponges placed within a belt will be positioned anteriorly in the inguinal region, and the other posteriorly in the Grynfeltt-Lesshaft triangle region. Breathing training will be provided in 3 different positions: sitting, crawling, and happy baby pose. Pelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises. Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position. | Behavioural | DNS Based breathing exercises+PFMT |
| Pelvic floor muscle trainingPelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises. Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position. | Behavioural | PFMT |
Primary outcome
Change of Menstruation Symptom Scale score
Time frame: 4 weeks after the intervention
Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.
Change in the McGill pain questionnaire score
Time frame: 4 weeks after the intervention
The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.
4 secondary outcomes
Change of Menstruation Symptom Scale score
Time frame: 3 months after the intervention
Change of Quality of Life score
Time frame: 4 weeks after the intervention
Change in the McGill pain questionnaire score
Time frame: 3 months after the intervention
Change of Quality of Life score
Time frame: 3 months after the intervention
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 15 Aug 2025.
- Derived from this study: PubMed 42271328Yakit Yesilyurt S, Birinci Olgun T, Dag Y, Donmez EN, Aytekin I, Erkanli ME, Budak A. Effect of pelvic floor muscle training with or without dynamic neuromuscular stabilization-based breathing on menstrual pain and symptoms of primary dysmenorrhea: a randomized controlled trial. BMC Womens Health. 2026 Jun 11. doi: 10.1186/s12905-026-04578-w. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training and Pelvic floor muscle training in people with Dysmenorrhea Primary and Pain Management, run by Izmir University of Economics 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 7 inclusion and 7 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 15 Aug 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?
Change of Menstruation Symptom Scale score (time frame: 4 weeks after the intervention). 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?
On the ClinicalTrials.gov record for NCT06615258, which also lists 1 linked publication.
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 15 Aug 2025.