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

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06026540
Collaborator
(none)
54
1
2
12
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pilates Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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".

Behavioral: Pilates Exercise
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: Control group

No intervention will be applied to the control group

Outcome Measures

Primary Outcome Measures

  1. Change in Premenstrual Syndrome Scale [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Betül Uncu Istanbul Turkey 34320

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Betul Uncu, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT06026540
Other Study ID Numbers:
  • 2023/01
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Betul Uncu, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2023