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Clinical Trials/NCT06176313
NCT06176313
Recruiting
N/A

Investigation of the Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms

Eskisehir Osmangazi University1 site in 1 country90 target enrollmentOctober 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premenstrual Syndrome
Sponsor
Eskisehir Osmangazi University
Enrollment
90
Locations
1
Primary Endpoint
the Premenstrual Syndrome Scale (PSS) for mandala pre-test
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms.

Research Hypotheses:

H01: Mandala activity is not effective in reducing premenstrual symptoms.

H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms.

H13: Mandala activity is effective in reducing premenstrual symptoms.

H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms.

H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS.

Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.

Detailed Description

In the conducted international and national literature review, it was observed that various methods are utilized in the management of PMS. Still, no study directly examining the effectiveness of Mandala activity on PMS was found. The literature results provided under the title of Mandala indicate that the activities are predominantly focused on behavioral and psychological conditions. Considering the symptoms of PMS, it is assumed that Mandala activity may have an impact on the behavioral and psychological symptoms of PMS. The assumption of how it might affect the physical symptoms of PMS is also supported by studies indicating that art itself has a therapeutic quality and that the creative process helps individuals develop positive coping methods for the physical discomfort they experience. The research is planned as a pre-test post-test control group design with a randomized controlled semi-experimental approach, aiming to determine the impact of education on coping with premenstrual syndrome and Mandala activity on premenstrual symptoms Research Hypotheses: H01: Mandala activity is not effective in reducing premenstrual symptoms. H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms. H13: Mandala activity is effective in reducing premenstrual symptoms. H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms. H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS. Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.

Registry
clinicaltrials.gov
Start Date
October 25, 2023
End Date
January 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Eskisehir Osmangazi University
Responsible Party
Principal Investigator
Principal Investigator

Merve SEZER YILDIZ

Phd.Student and Research Assistant

Bilecik Seyh Edebali Universitesi

Eligibility Criteria

Inclusion Criteria

  • Age between 18-25 years
  • Female students enrolled in the 1st and 2nd years of the Faculty of Health Sciences PMSÖ score of 110 and above
  • Regular menstruation in the last six months (between 21-35 days)
  • Not using any medication or non-medication methods to cope with PMS symptoms
  • Not using contraceptive pills
  • Absence of any gynecological diseases (abnormal uterine bleeding, fibroids, ovarian cysts, etc.)
  • No diagnosis of psychiatric illness
  • Not using any psychiatric medication such as antidepressants
  • Absence of any condition that may hinder Mandala drawing
  • No previous experience with Mandala education

Exclusion Criteria

  • Students who do not meet the criteria mentioned above and are not willing to participate in the study will be excluded.

Outcomes

Primary Outcomes

the Premenstrual Syndrome Scale (PSS) for mandala pre-test

Time Frame: pre-test

The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.

the Premenstrual Syndrome Scale (PSS) for education pre-test

Time Frame: pre-test

The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.

the Premenstrual Syndrome Scale (PSS) for control

Time Frame: pre-test

The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.

Secondary Outcomes

  • the Premenstrual Syndrome Scale (PSS) after mandala-1 session(Four days after the first menstrual bleeding.)
  • the Premenstrual Syndrome Scale (PSS) after mandala-2 session(Four days after the second menstrual bleeding.")
  • the Premenstrual Syndrome Scale (PSS) after mandala-3 session(Four days after the third menstrual bleeding.)
  • Premenstrual Syndrome Scale (PMSS) education final test(After the third menstrual bleeding, four days later.)
  • Premenstrual Syndrome Scale (PMSS) control final test(After the third menstrual bleeding, four days later.)

Study Sites (1)

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