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The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study

Primary Purpose

Premenstrual Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring healthy living, Peer guidance, pilates exercise, premenstrual syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Being an undergraduate student studying in the midwifery department of Istanbul University-Cerrahpaşa Faculty of Health Sciences, Having a score of 110 and above in PMSS, Having an internet connection, The Zoom program is installed and ready to use on its electronic device (phone or computer), Having the environment to do Pilates. Exclusion Criteria: Being under the age of 18, Changes in menstruation characteristics after the diagnosis of PMS, Having a chronic or physical illness that prevents Pilates exercise.

Sites / Locations

  • Betül Uncu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

Control group

Arm Description

After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via "Zoom" includes the following order: "Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes".

No intervention will be applied to the control group

Outcomes

Primary Outcome Measures

Change in Premenstrual Syndrome Scale
The lowest 44 and the highest 220 points can be obtained from the scale. The higher the score, the more severe the PMS problems are. If the person exceeds 50% of the total scale score (110 points in total) on the PMS scale, PMS is considered to be present.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
September 7, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT06026540
Brief Title
The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study
Official Title
The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

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

5. Study Description

Brief Summary
This project is to examine the effect of pilates exercise, which is applied by university students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle behaviors. Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of 385 female students studying at the Department of Midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences. In the study, it is aimed to reach all students without making a sample calculation in order to identify the students with PMS symptoms among all students. Students who score 110 and above on the Premenstrual Syndrome Scale (PMSS) will be considered to have PMS symptoms. The sample size of the students showing PMS symptoms was determined by using the G*Power (3.1.9.2) program and considering the 0.05 margin of error and data loss, according to 95% power and medium effect size; 27 people should be included in the experimental group and 27 people in the control group. In determining the groups, the participants will be assigned to the experimental and control groups using the "Randomizer.org" program. Students included in the research will be given information about the study and will be presented with an "Informed Consent Form" and a "Volunteer Consent Form". While the experimental group will be given pilates exercises, under the guidance of a peer, for half an hour twice a week for six months, the control group will maintain their routine habits. At the beginning of the study, data will be collected with the "Personal Information Form", "Premenstrual Syndrome Scale (PMSÖ)" and "Healthy Lifestyle Behaviors Scale-II (SYBDS-II)". In the third and sixth months of the study, the hypotheses will be tested by applying PMSS and HLBS-II. The data obtained in the research will be entered into the database in the IBM SPSS 25.0 (Statistical Package for the Social Sciences) program and all necessary statistical analyzes will be performed in the same program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
healthy living, Peer guidance, pilates exercise, premenstrual syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via "Zoom" includes the following order: "Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes".
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group
Intervention Type
Behavioral
Intervention Name(s)
Pilates Exercise
Intervention Description
After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via "Zoom" includes the following order: "Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes".
Primary Outcome Measure Information:
Title
Change in Premenstrual Syndrome Scale
Description
The lowest 44 and the highest 220 points can be obtained from the scale. The higher the score, the more severe the PMS problems are. If the person exceeds 50% of the total scale score (110 points in total) on the PMS scale, PMS is considered to be present.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being an undergraduate student studying in the midwifery department of Istanbul University-Cerrahpaşa Faculty of Health Sciences, Having a score of 110 and above in PMSS, Having an internet connection, The Zoom program is installed and ready to use on its electronic device (phone or computer), Having the environment to do Pilates. Exclusion Criteria: Being under the age of 18, Changes in menstruation characteristics after the diagnosis of PMS, Having a chronic or physical illness that prevents Pilates exercise.
Facility Information:
Facility Name
Betül Uncu
City
Istanbul
ZIP/Postal Code
34320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35534402
Citation
Itriyeva K. Premenstrual syndrome and premenstrual dysphoric disorder in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101187. doi: 10.1016/j.cppeds.2022.101187. Epub 2022 May 6.
Results Reference
background
PubMed Identifier
32522750
Citation
Pearce E, Jolly K, Jones LL, Matthewman G, Zanganeh M, Daley A. Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials. BJGP Open. 2020 Aug 25;4(3):bjgpopen20X101032. doi: 10.3399/bjgpopen20X101032. Print 2020 Aug.
Results Reference
background
PubMed Identifier
34879766
Citation
Erbil N, Yucesoy H. Premenstrual syndrome prevalence in Turkey: a systematic review and meta-analysis. Psychol Health Med. 2023 Jun;28(5):1347-1357. doi: 10.1080/13548506.2021.2013509. Epub 2021 Dec 8.
Results Reference
background
PubMed Identifier
33386201
Citation
Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.
Results Reference
background
PubMed Identifier
28318414
Citation
Tsai SY, Kuo FC, Kuo HC, Liao LL. The prevalence of self-reported premenstrual symptoms and evaluation of regular exercise with premenstrual symptoms among female employees in Taiwan. Women Health. 2018 Mar;58(3):247-259. doi: 10.1080/03630242.2017.1296056. Epub 2017 Mar 20.
Results Reference
background

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The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study

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