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

NCT06176313 | Unknown

• 1 other identifier: merve-sezer-yildiz-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

premenstrual syndrome; mandala; education; premenstrual symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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 Arms (3)

mandala

EXPERIMENTAL

Other: Mandala Group

Coping with Premenstrual Symptoms Education Group

EXPERIMENTAL

Other: Coping with Premenstrual Symptoms Education Group

Control Group

EXPERIMENTAL

Other: Control Group

Interventions

Mandala Group OTHER

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."

mandala

Coping with Premenstrual Symptoms Education Group OTHER

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.

Coping with Premenstrual Symptoms Education Group

Control Group OTHER

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."

Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Bilecik Şeyh Edebali University

Bilecik, Merkez, 11100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Coping Skills; Control Groups

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Merve SEZER YILDIZ, Ph.D. Student

  BİLECİK ŞEYH EDEBALİ UNİVERSITY

  PRINCIPAL INVESTIGATOR

• Özlem ÇAĞAN, Assist. Professor

  ESKİŞEHİR OSMANGAZİ UNİVERSITY

  STUDY DIRECTOR

Central Study Contacts

Merve SEZER YILDIZ, Ph.D. Std.

CONTACT

05301789126; merveyildiz@bilecik.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be performed by an investigator who was blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd.Student and Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 19, 2023
• Study Start: October 25, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)