Primary Dysmenorrhea (PD)
Conditions
Keywords
primary dysmenorrhea, Menstrual pain, Pelvic floor exercises, Diaphragmatic breathing, Physiotherapy, Pain management, Exercise therapy, Biopsychosocial model, Depression, anxiety, stress, Sleep quality, Non-pharmacological treatment, Randomized controlled trial (RCT), Women's health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPelvic Floor + 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.
BEHAVIORALDiaphragmatic Breathing Exercises
Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.
Sponsors
Istanbul Gelisim University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. No participants, care providers, investigators, or outcome assessors are blinded to group assignments.
Intervention model description
Participants will be randomly assigned to two parallel groups. The intervention group will perform a combined program of pelvic floor muscle and diaphragmatic breathing exercises, while the control group will perform only diaphragmatic breathing exercises. Both groups will be assessed at two time points: before and after the menstrual period.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Diagnosed with primary dysmenorrhea (PD) * Having regular menstrual cycles for the past 6 months * Willing to participate in the study
Exclusion criteria
* Diagnosis of secondary dysmenorrhea * Irregular menstrual cycles (less than 21 days or more than 35 days) * History of childbirth or previous pregnancy * Currently pregnant * Presence of any neurological, systemic, or psychiatric chronic disease * Regular use of medications in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (Visual Analog Scale, VAS) | 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment). | 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. |
| Pain Threshold (Pressure Algometer) | 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 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. |
| Menstrual Symptoms (Menstrual Symptom Scale - MSS) | 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment). | 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 |
| Premenstrual Symptoms (PMS Scale) | One week before menstruation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (SF-36) | 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment). | 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. |
| Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) | 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 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. |
| Depression, Anxiety, and Stress (DASS-21) | 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment). | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORIrmak KARDEŞ
Istanbul Gelişim University
Outcome results
None listed