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

Primary Purpose

Premenstrual Syndrome, Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Based Exercises
control
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring stress, Pilates Based Exercises

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • Üsküdar Unıversıty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

pilates group

Arm Description

Before 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.

After 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
October 12, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT05998044
Brief Title
Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
Official Title
Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
October 12, 2023 (Actual)
Study Completion Date
October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Stress
Keywords
stress, Pilates Based Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilates exercises will be given to the experimental group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Before 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.
Arm Title
pilates group
Arm Type
Experimental
Arm Description
After 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.
Intervention Type
Other
Intervention Name(s)
Pilates Based Exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
They will be asked not to participate in any regular exercise for 8 weeks.
Primary Outcome Measure Information:
Title
Premenstrual Syndrome Scale (PMSS)
Description
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.
Time Frame
10 weeks
Title
Perceived Stress Scale (PSS)
Description
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.
Time Frame
10 weeks
Title
McGill Melzack Pain Questionnaire (MPQ)
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Premenstrual syndrome is a female-specific disorder.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şeyma AYKUT
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12725453
Citation
Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
Results Reference
background
PubMed Identifier
33246104
Citation
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.
Results Reference
background
PubMed Identifier
25279689
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.
Results Reference
background
PubMed Identifier
23016028
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.
Results Reference
background
PubMed Identifier
22030232
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.
Results Reference
background

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

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