Menstrual PainSTAMPNCT07130292
Abdominal Muscle Strengthening for Menstrual Symptoms in Primary Dysmenorrhea
A study testing Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback in people with Menstrual Pain and Menstrual Disorders, run by Bulent Ecevit University.
Trial summary
This randomized controlled trial aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Menstrual Pain, Menstrual Disorders, Muscle Strength
- What is being tested?
- Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2025to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-25 years
- Regular menstrual cycles
- Diagnosed with primary dysmenorrhea (no secondary dysmenorrhea or other gynecological disorders)
- Menstrual pain intensity ≥ 4 on the Visual Analog Scale (VAS) during the menstrual cycle
- Willingness to participate and ability to provide informed consent
Who cannot join
- Diagnosis of secondary dysmenorrhea or other gynecological disorders (e.g., endometriosis, adenomyosis, uterine fibroids)
- Current pregnancy or breastfeeding
- History of abdominal or pelvic surgery in the past 6 months
- Current use of hormonal therapy or analgesic medication that could affect menstrual pain assessment
- Participation in regular abdominal or core strengthening exercise programs within the last 3 months
- Any musculoskeletal, neurological, or systemic condition that could interfere with exercise performance or study participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Abdominal Muscle Strengthening Using Stabilizer Pressure Biofeedback on Menstrual Symptoms and Abdominal Muscle Strength in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pelvic pathology, is common among women of reproductive age and can negatively affect quality of life.
In this study, 58 female participants aged 18-25 with regular menstrual cycles and a Visual Analog Scale (VAS) pain score of ≥4 will be randomly assigned to either an intervention group or a control group. The intervention group will perform abdominal strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, three times per week for 6 weeks (excluding menstruation weeks).
The main outcomes include menstrual symptom severity (assessed by the Menstrual Symptom Scale), pain intensity (VAS), and abdominal muscle strength (measured using the stabilizer pressure biofeedback device). The results will help determine whether targeted abdominal muscle training can reduce menstrual symptoms and improve muscle strength in women with primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea (PD) is one of the most common gynecological problems in women of reproductive age, characterized by spasmodic cramps in the lower abdomen before or during menstruation, without pelvic pathology. The underlying pathophysiology involves increased release of prostaglandin F2α during menstruation, leading to stronger uterine contractions, reduced blood flow, hypoxia, and pain. PD often begins soon after menarche and may be accompanied by nausea, vomiting, diarrhea, fatigue, and sleep disturbances.
Conventional treatment approaches include pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives. However, these treatments may have side effects and limited patient compliance. Non-pharmacological interventions, especially exercise programs, have shown potential in reducing menstrual pain by increasing endorphin release, relaxing uterine muscles, and improving regional blood flow. Strengthening abdominal and core muscles can improve pelvic stability and potentially reduce dysmenorrhea symptoms.
The stabilizer pressure biofeedback unit is a simple, non-invasive device that provides visual feedback during muscle activation, helping to target deep stabilizing muscles such as the transversus abdominis. By enhancing activation capacity, it may improve abdominal muscle strength and reduce menstrual symptoms.
Study Design:
This is a randomized, controlled, single-blind trial. Fifty-eight eligible women aged 18-25 with regular menstrual cycles, a VAS score ≥4, and no diagnosis of secondary dysmenorrhea or other gynecological disorders will be enrolled. Participants will be allocated to the intervention or control group using permuted block randomization. Assessments will be conducted three times: at baseline (first day of the menstrual cycle), mid-intervention (week 3-4), and post-intervention (week 8).
Intervention:
The intervention group will perform a structured exercise program targeting the lumbar and abdominal muscles, supervised three times per week for 6 weeks (excluding menstruation weeks). Exercises will include stretching, mobility, and strengthening activities, with abdominal muscle training guided by a stabilizer pressure biofeedback device. The control group will not receive this intervention during the study period.
Outcome Measures:
Primary outcomes: Menstrual symptom severity (Menstrual Symptom Scale), pain intensity (VAS).
Secondary outcome: Abdominal muscle strength (stabilizer pressure biofeedback).
Significance:
This study will provide evidence on whether non-pharmacological abdominal muscle strengthening using stabilizer pressure biofeedback can reduce menstrual symptoms and improve muscle strength in young women with primary dysmenorrhea. The findings may guide future exercise-based interventions for menstrual pain management.
- Conditions
- Menstrual Pain, Menstrual Disorders, Muscle Strength
- Being tested
- Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback
- Keywords
- Primary Dysmenorrhea, Abdominal Muscle Strengthening, Stabilizer Pressure Biofeedback
- Medical subject headings
- Dysmenorrhea, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Muscle Strengthening Exercises with Stabilizer Pressure BiofeedbackBehavioural
A supervised exercise program designed to strengthen abdominal and lumbar muscles, incorporating the use of a stabilizer pressure biofeedback device to enhance activation of deep stabilizing muscles such as the transversus abdominis. The program is delivered three times per week for 6 weeks (excluding menstruation weeks) and includes mobility, stretching, and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback | Experimental | Participants perform a structured exercise program targeting lumbar and abdominal muscles, guided by a stabilizer pressure biofeedback device. Sessions are supervised three times per week for 6 weeks (excluding menstruation weeks) and include mobility, stretching, and strengthening exercises to improve abdominal muscle activation and core stability. Receives: Behavioral: Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback |
| Control - No Abdominal Muscle Strengthening Intervention | No intervention | Participants receive no abdominal muscle strengthening program during the study period. They continue their usual daily activities without any supervised exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Symptom Severity
Change in menstrual symptom severity as assessed by the Menstrual Symptom Scale (MSS). The MSS consists of 22 items scored on a 5-point Likert scale, with higher scores indicating more severe symptoms.
Measured: Change from Baseline (Week 0) to Post-intervention (Week 8)
Pain Intensity
Visual Analog Scale 0-10 cm (0 = no pain, 10 = worst pain). Outcome is mean change from baseline to Week 8.
Measured: Change from Baseline (Week 0) to Post-intervention (Week 8)
Abdominal Muscle Activation/Strength (Pressure Biofeedback)
Abdominal muscle activation measured with a Stabilizer Pressure Biofeedback Unit (mmHg). Lower pressure during correct drawing-in reflects better transversus abdominis activation. Outcome is change from baseline to Week 8
Measured: Change from Baseline (Week 0) to Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start13 Aug 2025 (estimated)
- Primary completion23 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be randomly assigned into two parallel groups: an intervention group receiving abdominal muscle strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, and a control group receiving no such intervention during the study period. Both groups will be evaluated at baseline, mid-intervention, and post-intervention over an 8-week period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanem ŞENER, Bulent Ecevit University
- Investigators
- Assistant Professor of Physiotherapy, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130292
- Sponsor's protocol ID
- ZBEU-SPB-PD-2025-01
- Acronym
- STAMP
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study protocol and informed consent do not include provisions for public data sharing, and data protection regulations restrict the release of personally identifiable health information.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Muscle Strengthening Using Stabilizer Pressure Biofeedback on Menstrual Symptoms and Abdominal Muscle Strength in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07130292
- Acronym / sponsor ID
- STAMP / ZBEU-SPB-PD-2025-01
- Conditions
- Menstrual Pain, Menstrual Disorders, Muscle Strength
- Keywords
- Primary Dysmenorrhea, Abdominal Muscle Strengthening, Stabilizer Pressure Biofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 13 Aug 2025 (estimated)
- Primary completion
- 23 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 19 Aug 2025 (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 aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pelvic pathology, is common among women of reproductive age and can negatively affect quality of life.
In this study, 58 female participants aged 18-25 with regular menstrual cycles and a Visual Analog Scale (VAS) pain score of ≥4 will be randomly assigned to either an intervention group or a control group. The intervention group will perform abdominal strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, three times per week for 6 weeks (excluding menstruation weeks).
The main outcomes include menstrual symptom severity (assessed by the Menstrual Symptom Scale), pain intensity (VAS), and abdominal muscle strength (measured using the stabilizer pressure biofeedback device). The results will help determine whether targeted abdominal muscle training can reduce menstrual symptoms and improve muscle strength in women with primary dysmenorrhea.
Detailed description
Primary dysmenorrhea (PD) is one of the most common gynecological problems in women of reproductive age, characterized by spasmodic cramps in the lower abdomen before or during menstruation, without pelvic pathology. The underlying pathophysiology involves increased release of prostaglandin F2α during menstruation, leading to stronger uterine contractions, reduced blood flow, hypoxia, and pain. PD often begins soon after menarche and may be accompanied by nausea, vomiting, diarrhea, fatigue, and sleep disturbances.
Conventional treatment approaches include pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives. However, these treatments may have side effects and limited patient compliance. Non-pharmacological interventions, especially exercise programs, have shown potential in reducing menstrual pain by increasing endorphin release, relaxing uterine muscles, and improving regional blood flow. Strengthening abdominal and core muscles can improve pelvic stability and potentially reduce dysmenorrhea symptoms.
The stabilizer pressure biofeedback unit is a simple, non-invasive device that provides visual feedback during muscle activation, helping to target deep stabilizing muscles such as the transversus abdominis. By enhancing activation capacity, it may improve abdominal muscle strength and reduce menstrual symptoms.
Study Design:
This is a randomized, controlled, single-blind trial. Fifty-eight eligible women aged 18-25 with regular menstrual cycles, a VAS score ≥4, and no diagnosis of secondary dysmenorrhea or other gynecological disorders will be enrolled. Participants will be allocated to the intervention or control group using permuted block randomization. Assessments will be conducted three times: at baseline (first day of the menstrual cycle), mid-intervention (week 3-4), and post-intervention (week 8).
Intervention:
The intervention group will perform a structured exercise program targeting the lumbar and abdominal muscles, supervised three times per week for 6 weeks (excluding menstruation weeks). Exercises will include stretching, mobility, and strengthening activities, with abdominal muscle training guided by a stabilizer pressure biofeedback device. The control group will not receive this intervention during the study period.
Outcome Measures:
Primary outcomes: Menstrual symptom severity (Menstrual Symptom Scale), pain intensity (VAS).
Secondary outcome: Abdominal muscle strength (stabilizer pressure biofeedback).
Significance:
This study will provide evidence on whether non-pharmacological abdominal muscle strengthening using stabilizer pressure biofeedback can reduce menstrual symptoms and improve muscle strength in young women with primary dysmenorrhea. The findings may guide future exercise-based interventions for menstrual pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: an intervention group receiving abdominal muscle strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, and a control group receiving no such intervention during the study period. Both groups will be evaluated at baseline, mid-intervention, and post-intervention over an 8-week period.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback | Experimental | Behavioral: Abdominal Muscle Strengthening Exercises with Stabilizer Pressure BiofeedbackParticipants perform a structured exercise program targeting lumbar and abdominal muscles, guided by a stabilizer pressure biofeedback device. Sessions are supervised three times per week for 6 weeks (excluding menstruation weeks) and include mobility, stretching, and strengthening exercises to improve abdominal muscle activation and core stability. |
| Control - No Abdominal Muscle Strengthening Intervention | No intervention | –Participants receive no abdominal muscle strengthening program during the study period. They continue their usual daily activities without any supervised exercise intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged 18-25 years
- Regular menstrual cycles
- Diagnosed with primary dysmenorrhea (no secondary dysmenorrhea or other gynecological disorders)
- Menstrual pain intensity ≥ 4 on the Visual Analog Scale (VAS) during the menstrual cycle
- Willingness to participate and ability to provide informed consent
Key exclusion criteria (6 listed)
- Diagnosis of secondary dysmenorrhea or other gynecological disorders (e.g., endometriosis, adenomyosis, uterine fibroids)
- Current pregnancy or breastfeeding
- History of abdominal or pelvic surgery in the past 6 months
- Current use of hormonal therapy or analgesic medication that could affect menstrual pain assessment
- Participation in regular abdominal or core strengthening exercise programs within the last 3 months
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 |
|---|---|---|
| Abdominal Muscle Strengthening Exercises with Stabilizer Pressure BiofeedbackA supervised exercise program designed to strengthen abdominal and lumbar muscles, incorporating the use of a stabilizer pressure biofeedback device to enhance activation of deep stabilizing muscles such as the transversus abdominis. The program is delivered three times per week for 6 weeks (excluding menstruation weeks) and includes mobility, stretching, and strengthening exercises. | Behavioural | Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback |
Primary outcome
Menstrual Symptom Severity
Time frame: Change from Baseline (Week 0) to Post-intervention (Week 8)
Change in menstrual symptom severity as assessed by the Menstrual Symptom Scale (MSS). The MSS consists of 22 items scored on a 5-point Likert scale, with higher scores indicating more severe symptoms.
Pain Intensity
Time frame: Change from Baseline (Week 0) to Post-intervention (Week 8)
Visual Analog Scale 0-10 cm (0 = no pain, 10 = worst pain). Outcome is mean change from baseline to Week 8.
Abdominal Muscle Activation/Strength (Pressure Biofeedback)
Time frame: Change from Baseline (Week 0) to Post-intervention (Week 8)
Abdominal muscle activation measured with a Stabilizer Pressure Biofeedback Unit (mmHg). Lower pressure during correct drawing-in reflects better transversus abdominis activation. Outcome is change from baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study protocol and informed consent do not include provisions for public data sharing, and data protection regulations restrict the release of personally identifiable health information.
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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.
Assistant Professor of Physiotherapy principal investigator
Zonguldak Bulent Ecevit University
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback in people with Menstrual Pain and Menstrual Disorders, run by Bulent Ecevit University.
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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanem ŞENER (+90 553-591-83-96, sanemsener@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Symptom Severity (time frame: Change from Baseline (Week 0) to Post-intervention (Week 8)). 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?
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 19 Aug 2025.