An interventional study of Pelvic Floor + Breathing Exercises and Diaphragmatic Breathing Exercises in Primary Dysmenorrhea (PD), sponsored by Istanbul Gelisim University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Istanbul Gelisim University · Not applicable, Interventional, and Treatment
This study investigates whether combining pelvic floor muscle exercises with diaphragmatic breathing exercises can reduce menstrual pain in women with primary dysmenorrhea. Forty participants will be randomly assigned to two groups: one performing both exercises, and the other performing only diaphragmatic breathing. The study will measure pain, menstrual symptoms, quality of life, and psychological well-being before and after the intervention.
This interventional study aims to investigate the combined effects of pelvic floor muscle exercises and diaphragmatic breathing exercises on primary dysmenorrhea in women. The study is designed based on a biopsychosocial model to explore both physical and psychological outcomes of the intervention.
A total of 40 participants will be recruited and randomly assigned to two groups. The intervention group will perform a program combining pelvic floor and diaphragmatic breathing exercises, while the control group will perform only diaphragmatic breathing exercises. The exercise program will be conducted over a specified period, with sessions scheduled regularly according to the study protocol.
Assessments will be conducted twice: prior to and after the menstrual period. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and pain threshold will be measured with a pressure algometer. Menstrual and premenstrual symptoms, quality of life, sleep quality, and psychological status, including depression, anxiety, and stress levels, will be assessed using validated scales such as the PMS Scale, SF-36, DASS-21, and PUKI.
This study is expected to provide scientific evidence for physiotherapy interventions in women's health and offer an alternative non-pharmacological approach for managing primary dysmenorrhea. By addressing both physical and psychological aspects, the exercise program may reduce pain, improve quality of life, and enhance overall well-being in participants.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Istanbul Gelisim University is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will perform a combined program of pelvic floor muscle exercises and diaphragmatic breathing exercises. The exercises will be conducted according to the study protocol, with sessions scheduled regularly over the intervention period. Both physical and psychological outcomes will be assessed before and after the menstrual period.
Behavioral: Pelvic Floor + Breathing Exercises
Participants will perform only diaphragmatic breathing exercises according to the study protocol. Assessments of pain, menstrual symptoms, quality of life, sleep quality, and psychological measures will be conducted before and after the menstrual period.
Behavioral: Diaphragmatic Breathing Exercises
Participants will perform both pelvic floor and diaphragmatic breathing exercises according to the study protocol. Assessments will focus on pain, quality of life, and psychological measures.
Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.
Pain intensity (Visual Analog Scale, VAS)
Pain severity will be assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain level, which will then be measured with a ruler to obtain a numerical value.
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Pain Threshold (Pressure Algometer)
Pain threshold will be assessed at six anatomical points using a pressure algometer. Pressure is gradually increased until participants report pain. Two measurements per point are recorded, with the mean value calculated in lbs/cm².
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Menstrual Symptoms (Menstrual Symptom Scale - MSS)
The severity of menstrual symptoms will be assessed using the Menstrual Symptom Scale (MSS), whose Turkish validity and reliability were established by Güvenç, Seven, and Akyüz (2014). The scale consists of 22 items, each rated on a 5-point Likert scale from 1 ("never") to 5 ("always"). Minimum possible total score: 22 points Maximum possible total score: 110 points
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Premenstrual Symptoms (PMS Scale)
Premenstrual symptoms will be assessed using the 44-item PMS Scale, covering nine subscales such as depressive mood, anxiety, fatigue, irritability, pain, sleep, and appetite changes. The total score of the scale is obtained by summing the scores from all subscales, ranging from 44 to 220 points. Higher scores indicate a greater severity of premenstrual syndrome (PMS) symptoms.
Time frame: One week before menstruation
Quality of Life (SF-36)
The Short Form-36 (SF-36) questionnaire evaluates physical and mental health across 8 subscales. Scores range from 0-100, with higher scores indicating better quality of life.
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Sleep quality will be measured with the PSQI, a 24-item questionnaire assessing sleep duration, quality, disturbances, and daytime dysfunction. Total scores range from 0-21; higher scores indicate poorer sleep quality.
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Depression, Anxiety, and Stress (DASS-21)
DASS-21 assesses levels of depression, anxiety, and stress across 21 items. Each subscale includes 7 items, rated on a 0-3 Likert scale. Higher scores indicate greater severity of symptoms.
Time frame: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for May 2026, 3 months after the start.
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 3 months is below that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Gelisim University