Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial

Stress Clinical Trial

Official title:

Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05998044
• Other study ID #: Uskudar66
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 12, 2023

Study information

• Verified date: September 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. The sample of the study consisted of people who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and volunteered to participate in the study. Participants will be divided into 2 groups as experimental group and control group by randomization method. Sociodemographic Information Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data were statistically analyzed and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Stress

Intervention

Other:
• Pilates Based Exercises
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
• control
They will be asked not to participate in any regular exercise for 8 weeks.

Locations

Country	Name	City	State
Turkey	Üsküdar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Citil 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. — View Citation

Cruz-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. — View Citation

Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285. — View Citation

Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52. — View Citation

El-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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