Clinical trial NCT06191536: The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With PMS
Official title: The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Pelvic Floor Disorders
Quality of Life
Keywords: Premenstrual Syndrome
Pelvic Floor Exercises
Pilates
Quality of Life
Pain
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Physiological symptoms; edema, headache, fatigue, weight gain and breast swelling and tenderness, and psychological symptoms; It can be seen as tension, anger, depressed mood or stress. Although it usually ends with the onset of menstruation, its repetition with each menstrual cycle affects the individual's pain coping strategies, sleep and quality of life.

Different methods such as pharmacological agents, physiotherapy applications, nutrition and lifestyle adjustments, breathing exercises, stress management, meditation and cognitive behavioral therapy are used to cope with PMS, which appears with symptoms of different severities from individual to individual.

Detailed description: Exercise; It is known to have positive physical and psychological effects on PMS symptoms by reducing muscle cramps, increasing circulation and controlling the neuromuscular system. Pilates, as an exercise method that combines body-mind conditioning with breathing control and focuses on lumbopelvic stability and targets core stabilization, is also thought to have a significant effect on increasing pelvic floor muscle strength by performing it together with pelvic floor muscle contraction. In addition, considering the anatomical connection of the pelvic floor muscles with other core muscles, it has been observed that pelvic floor muscle contractions also occur during abdominal muscle contraction. The pelvic floor consists of a group of muscles and connective tissues that extend like a sling across the pelvic floor; It consists of two layers, the superficial perineal muscles and the deep pelvic diaphragm, and provides support to the pelvic organs, bladder and elements of the spine. Pelvic floor exercises are a safe and effective means of decreasing the symptoms and signs of pelvic disorders. In the literature, it is seen that these exercises are effective in urinary incontinence.

There is no study examining the effect of pelvic floor muscle training combined with pilates on PMS symptoms. The purpose of this study; To examine the effects of pelvic floor exercises, in addition to pilates exercises, on PMS symptoms, pain, sleep and quality of life in individuals with premenstrual syndrome.

Eligibility criteria: Inclusion Criteria:

* Be willing to participate in research
* Getting a score of 111 or higher on the PMS Scale,
* Experiencing premenstrual symptoms for at least 3 months,
* Having a pain score of at least 4 on the Visual Analogue Scale during any menstrual period within the last 3 months.
* Regular menstrual cycle for 12 months (24-35 days),

Exclusion Criteria:

* Being under 18 years of age,
* Change in menstrual characteristics after PMS diagnosis,
* Having a chronic or physical illness that prevents you from doing Pilates.
* People who have had surgery in the last 6 months,
* Individuals with musculoskeletal system problems,
* Individuals with chronic diseases,
* People receiving hormone therapy,
* Pregnant individuals,
* People with urinary, genital or gastrointestinal disorders,
* People who have had hysterectomy surgery.

Primary outcomes:
measure: Premenstrual Syndrome Scale (PMSS)
timeFrame: 6 months
Secondary outcomes:
measure: SF-12
timeFrame: 6 Months
measure: Pittsburgh Sleep Qualıty Index (PUKI)
timeFrame: 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Heracity Pilates
Study officials:
affiliation: Uskudar University
name: osman coban, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
citation: Leite A, Matignon A, Marlot L, Coelho A, Lopes S, Brochado G. The Impact of Clinical Pilates Exercises on Tension-Type Headaches: A Case Series. Behav Sci (Basel). 2023 Jan 27;13(2):105. doi: 10.3390/bs13020105.
citation: Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.
citation: Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.