The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With PMS

Quality of Life Clinical Trial

Official title:

The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With Premenstrual Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191536
• Other study ID #: UskudarUniversitesi
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Uskudar University
• Contact: osman coban, PhD
• Phone: 00905337242919
• Email: oscoban28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Premenstrual Syndrome
• Quality of Life
• Syndrome

Intervention

Other:
• Pilates

• Pelvic floor exercises

Locations

Country	Name	City	State
Turkey	Heracity Pilates	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual Syndrome Scale (PMSS)	The Premenstrual Syndrome Scale (PMSS) is a 44-item questionnaire based on a five-point Likert-type scale with scores ranging from 1 to 5. (Never, Rarely, Sometimes, Often, Constantly) Pmss has nine subscales, including Depressive Affects, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Swelling. The PMSS total score is the sum of the scores of these nine subscales. The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the greater the intensity of PMS symptoms. In order to be diagnosed with PMS, it is necessary to get 50% of the total score (111 points).	6 months
Secondary	SF-12	Similar to SF-36, SF-12 includes physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item). It consists of 8 subscales and 12 items, including emotional role (2 items) and mental health (2 items). While items related to physical and emotional roles are answered as dikatomis (yes or no), other items have Likert-type options ranging from 3 to 6. It is possible to obtain separate scores for each subscale, the score of the subscales varies between 0 and 100, with a higher score representing better health.	6 Months
Secondary	Pittsburgh Sleep Quality Index (PUKI)	PSQI is a sleep questionnaire that helps evaluate the person's sleep quality, amount of sleep, and the presence and severity of sleep disorders for the last month.; This scale has 19 items and measures seven subcomponents of sleep quality, including subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping pill use, and daytime dysfunction. The total PSQI score is obtained by summing the seven subscores and the total score is between 0-21. Each component is evaluated on a scale of 0-3 points. PSQI total score clearly distinguishes good sleepers (PSQI total score =5) from poor sleepers (PSQI >5).	6 months
Secondary	Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) is an evaluation method used to convert the pain perception level, which cannot be measured numerically, into a numerical form. In the evaluation, two extreme definitions of pain were written at both ends of a 100 mm line (I have no pain at one end, the most unbearable pain at the other end). The patient was asked to indicate where his/her current situation corresponds to on this line by drawing a line, placing a dot, or pointing. The distance from the point where there was no pain to the point marked by the patient, measured in mm with a ruler, showed the patient's pain level. Pain level was recorded as activity and rest VAS in the absence of bleeding.	6 Months