Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2023
CompletedOctober 13, 2023
September 1, 2023
2 months
August 9, 2023
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Premenstrual Syndrome Scale (PMSS)
PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the "being in the period one week before the period". In scoring the scale, "Never" option is evaluated as 1 point, "Very little" option as 2 points, "Sometimes" option as 3 points, "Often" option as 4 points and "Constantly" option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.
10 weeks
Perceived Stress Scale (PSS)
The perceived stress scale consists of 14 five-point Likert type items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.
10 weeks
McGill Melzack Pain Questionnaire (MPQ)
MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.
10 weeks
Study Arms (2)
control group
ACTIVE COMPARATORBefore starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied.
pilates group
EXPERIMENTALAfter people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied.
Interventions
The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. Exercise Program: * Arm Circles * Toe Touch * bridge * Shoulder Bridge * Chest Lift * Hundred * Roll Up * Leg Circles * Chris Cross * Side Kick * Side Leg Circles * one leg kick * double leg kick * Swan * Single leg Stretch * Double leg Stretch * saw * Spine Stretch
Eligibility Criteria
You may qualify if:
- Being a woman between the ages of 18-35.
- Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary, mental diseases, etc. that will prevent exercise).
- Not having given birth.
- Volunteer to participate in the study.
- Having a score above the mild level on the PMSS score.
- Normal menstrual cycle.
You may not qualify if:
- Having a condition that prevents you from exercising.
- Having a chronic disease.
- Being on any medication regularly.
- Being pregnant.
- Being in the menopausal period.
- Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, fibroid/uterine tumor etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Üsküdar Unıversıty
Istanbul, Turkey (Türkiye)
Related Publications (5)
Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
PMID: 12725453BACKGROUNDCitil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
PMID: 33246104BACKGROUNDEl-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.
PMID: 25279689BACKGROUNDDi Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.
PMID: 23016028BACKGROUNDCruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
PMID: 22030232BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Şeyma AYKUT
Uskudar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
August 9, 2023
First Posted
August 18, 2023
Study Start
August 1, 2023
Primary Completion
October 12, 2023
Study Completion
October 12, 2023
Last Updated
October 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share