An interventional study of Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback in Menstrual Pain, Menstrual Disorders and Muscle Strength, sponsored by Bulent Ecevit University. Not yet recruiting. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Bulent Ecevit University · Not applicable, Interventional, and Treatment
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 58 is close to the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Bulent Ecevit University is the lead sponsor of 47 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback
Participants receive no abdominal muscle strengthening program during the study period. They continue their usual daily activities without any supervised exercise intervention.
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.
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.
Time frame: 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.
Time frame: 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
Time frame: Change from Baseline (Week 0) to Post-intervention (Week 8)
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 1 month is below that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Bulent Ecevit University