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

NCT06191536 | Completed

• 1 other identifier: UskudarUniversitesi
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome; Pelvic Floor Disorders; Quality of Life

Keywords

Premenstrual Syndrome; Pelvic Floor Exercises; Pilates; Quality of Life; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SF-12

  6 Months

• Pittsburgh Sleep Qualıty Index (PUKI)

  6 months

• Visual Analogue Scale (VAS)

  6 Months

Study Arms (2)

Pilates Group (PG)

EXPERIMENTAL

Pilates exercises will be performed under the supervision of a certified pilates instructor. Pilates exercises will be performed for 50 minutes, 2 days a week for 8 weeks.

Other: Pilates

Pelvic Floor Exercise Group (PFEG)

ACTIVE COMPARATOR

It consists of voluntary pelvic floor muscle contractions applied in addition to pilates exercises. Pelvic floor muscle contractions involve maximum contraction of the pelvic floor muscles alternately for five repetitions during exhalation. Pelvic floor exercises will be applied under the supervision of a pelvic floor certified physiotherapist. In addition to pilates exercises, pelvic floor exercises will be applied 2 days a week, 50 minutes, for 8 weeks.

Other: Pilates; Other: Pelvic floor exercises

Interventions

Pilates OTHER

Pelvic Floor Exercise Group (PFEG); Pilates Group (PG)

Pelvic floor exercises OTHER

Pelvic Floor Exercise Group (PFEG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Heracity Pilates

Istanbul, 34000, Turkey (Türkiye)

Location

Related 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.

  PMID: 20094704 BACKGROUND

• 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.

  PMID: 36829334 BACKGROUND

• 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.

  PMID: 22033000 BACKGROUND

• 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.

  PMID: 35730511 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Pelvic Floor Disorders; Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• osman coban, PhD

  Uskudar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2013
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)