Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms (MANDALA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Mandala Group; Other: Coping with Premenstrual Symptoms Education Group; Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve SEZER YILDIZ, Ph.D. Std.; Phone Number: 05301789126; Email: merveyildiz@bilecik.edu.tr

Study Locations

• Turkey
  • Merkez
    • Bilecik, Merkez, Turkey, 11100
      • Recruiting
      • Bilecik Seyh Edebali University
      • Contact: MERVE SEZER YILDIZ, Ph.D.Stdnt; Phone Number: 05301789126; Email: mervesezer55@gmail.com
      • Contact: Email: mervesezer55@gmail.com
      • Principal Investigator: MERVE SEZER YILDIZ, Ph.D.Stdnt
      • Sub-Investigator: ÖZLEM ÇAĞAN, Assist.Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Willingness to participate in the study
• Proficiency in speaking and understanding Turkish

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Group	Other: Control Group; No intervention will be applied to the control group throughout the research. However, students in this group who cope with premenstrual syndrome using medication or non-medication methods will be monitored during the three-month menstrual cycle. Each student's menstrual cycle in the control group has been recorded in the Excel table. The estimated end of menstruation for each student has been noted.; At the estimated end of menstruation, the researcher contacts the students in the control group to inquire whether they have used any medication or non-medication methods to cope with premenstrual syndrome.; Those who use medication or non-medication methods to reduce premenstrual symptoms are excluded from the study.; On the 4th day of the 4th menstrual period bleeding, the post-test with PMSÖ will be applied to the students."
Experimental: mandala	Other: Mandala Group; The Mandala activity lasts approximately 60 minutes. • A calm environment is provided during the Mandala activity, and participants are ensured not to be disturbed by external stimuli or individuals unless they request assistance. Each student's last menstrual date is recorded in an Excel table.; Two days before the intervention day, students will be contacted and invited to participate in the study.; Monitoring each student's menstrual cycle, the Mandala activity intervention is scheduled during the late luteal phase of each student's menstrual cycle. The intervention is planned within the 5 days before the expected start of menstrual bleeding on days and hours convenient for the student's class schedule.; After each session, on the 4th day of the expected menstrual bleeding, students are subjected to PMSÖ.; On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students."
Experimental: Coping with Premenstrual Symptoms Education Group	Other: Coping with Premenstrual Symptoms Education Group; The education will be conducted through face-to-face interviews in the master's course classroom at the Faculty of Health Sciences at Bilecik Şeyh Edebali University. The education was conducted using PowerPoint presentations projected onto a white smartboard.; One month after the completion of the education, a 1st Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method.; One month after the 1st Reminder training, a 2nd Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method.; On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Premenstrual Syndrome Scale (PSS) for mandala 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.	pre-test
the Premenstrual Syndrome Scale (PSS) for education 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.	pre-test
the Premenstrual Syndrome Scale (PSS) for control	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.	pre-test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Premenstrual Syndrome Scale (PSS) after mandala-1 session	Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 1st Mandala session. Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study. 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.	Four days after the first menstrual bleeding.
the Premenstrual Syndrome Scale (PSS) after mandala-2 session	Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 2st Mandala session. Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study. 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.	Four days after the second menstrual bleeding."
the Premenstrual Syndrome Scale (PSS) after mandala-3 session	Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 3st Mandala session. Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study. 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.	Four days after the third menstrual bleeding.
Premenstrual Syndrome Scale (PMSS) education final test	Premenstrual Syndrome Scale (PMSS): 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.	After the third menstrual bleeding, four days later.
Premenstrual Syndrome Scale (PMSS) control final 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.	After the third menstrual bleeding, four days later.

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Merve SEZER YILDIZ, Ph.D. Student, Bilecik Seyh Edebali University; Study Director: Özlem ÇAĞAN, Assist. Professor, Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: education; premenstrual syndrome; mandala; premenstrual symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: merve-sezer-yildiz-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No