Clinical trial NCT06176313: Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
Official title: Investigation of the Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: premenstrual syndrome
mandala
education
premenstrual symptoms
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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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Primary outcomes:
measure: the Premenstrual Syndrome Scale (PSS) for mandala pre-test
timeFrame: pre-test
measure: the Premenstrual Syndrome Scale (PSS) for education pre-test
timeFrame: pre-test
measure: the Premenstrual Syndrome Scale (PSS) for control
timeFrame: pre-test
Secondary outcomes:
measure: the Premenstrual Syndrome Scale (PSS) after mandala-1 session
timeFrame: Four days after the first menstrual bleeding.
measure: the Premenstrual Syndrome Scale (PSS) after mandala-2 session
timeFrame: Four days after the second menstrual bleeding."
measure: the Premenstrual Syndrome Scale (PSS) after mandala-3 session
timeFrame: Four days after the third menstrual bleeding.
measure: Premenstrual Syndrome Scale (PMSS) education final test
timeFrame: After the third menstrual bleeding, four days later.
measure: Premenstrual Syndrome Scale (PMSS) control final test
timeFrame: After the third menstrual bleeding, four days later.
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Şeyh Edebali University
state: Merkez
Study officials:
affiliation: BİLECİK ŞEYH EDEBALİ UNİVERSITY
name: Merve SEZER YILDIZ, Ph.D. Student
role: PRINCIPAL_INVESTIGATOR
affiliation: ESKİŞEHİR OSMANGAZİ UNİVERSITY
name: Özlem ÇAĞAN, Assist. Professor
role: STUDY_DIRECTOR
References: