Clinical trial NCT05428813: The Effect of Art on Premenstrual Syndrome Symptoms
Official title: The Effect of Art on Premenstrual Syndrome Symptoms: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Syndrome, Art, Women Health
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to determine the effect of art therapy techniques on premenstrual syndrome symptoms.The study is a randomized controlled type study. The study will be conducted with 70 female students with premenstrual syndrome. In the study, which consists of two groups, experimental (n=35) and control (n=35), art therapy techniques will be applied to the students in the experimental group for 8 weeks. The control group will continue their routine coping habits. Both groups will be evaluated with the Premenstrual Syndrome scale at the end of the study, and the difference between the groups will be examined.

Detailed description: First of all, ethics committee approval will be obtained by applying to the Non-Interventional Ethics Committee of the Rectorate of Kütahya Health Sciences University for the research. Then, written permission will be obtained from the Dean of the Faculty of Health Sciences of Kütahya Health Sciences University and the Department of Midwifery. In addition, written consent was obtained for the PMSS to be used in the research. At the first stage, the researcher will apply the research forms to all midwifery students willing to participate in the study without using any sampling method. The forms will be applied to volunteer and willing students after the lesson, in an appropriate classroom, by explaining the research and purpose. It is anticipated that the filling time of the forms will be 15-20 minutes on average. Then, all data will be evaluated in the SPSS program and randomization will be provided among the students who meet the inclusion criteria. Participants will be evaluated in two groups. One of the groups is the study group, where artistic techniques will be applied, and the other group is the control group, which will continue their routine coping habits for PMS. Participants will be randomly assigned to one of two groups using the www.randomizer.org program. Students in the study group (35) will do group work that will last for 30-35 minutes, one day a week, for 8 weeks, with the Artistic Techniques Education Directive prepared by the researcher holding a certificate on artistic techniques in parallel with the education they received. There is no intervention or therapy involved here. Art is used as an expressive technique, and these techniques enable students to better understand and interpret their own emotions at the end of their activity. The researcher will only apply the techniques and pose non-directive questions. At the same time, these techniques raise awareness. At the end of 8 weeks, students will be reassessed with PMSS. Students in the control group (35) will not be subjected to any application, and in parallel with the study group, they will be told to continue their routine habits regarding PMS. At the end of 8 weeks, students will be reassessed with PMSS.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Willing and volunteering to work,
* Being able to read and write and understand what one reads,
* Getting a score of 110 and above in PMSS

Exclusion Criteria:

* Engaging in any artistic activity,
* Having experienced changes in the menstrual cycle in the last 6 months

Primary outcomes:
measure: Techniques to be applied in the experimental group
timeFrame: It includes an 8-week process.
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Science University
Study officials:
affiliation: Kütahya Health Science University
name: Elif Tuğçe ÇİTİL, PhD
role: PRINCIPAL_INVESTIGATOR
References: