Clinical trial NCT06615258: The Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea Primary
Pain Management
Diaphragmatic Breathing
Pelvic Floor Muscle Exercise
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Menstruation Symptom Scale score
timeFrame: 4 weeks after the intervention
measure: Change in the McGill pain questionnaire score
timeFrame: 4 weeks after the intervention
Secondary outcomes:
measure: Change of Menstruation Symptom Scale score
timeFrame: 3 months after the intervention
measure: Change of Quality of Life score
timeFrame: 4 weeks after the intervention
measure: Change in the McGill pain questionnaire score
timeFrame: 3 months after the intervention
measure: Change of Quality of Life score
timeFrame: 3 months after the intervention
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir University of Economics
Study officials:
References: