The Effect of Art on Premenstrual Syndrome Symptoms
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
art therapy techniques
Sponsored by
About this trial
This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Art, Women Health
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
Sites / Locations
- Kütahya Health Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
The group to which art therapy techniques will be applied.
The group that will continue their routine coping habits related to premenstrual syndrome.
Outcomes
Primary Outcome Measures
Techniques to be applied in the experimental group
At the end of 8 weeks, improvement in premenstrual syndrome symptoms is expected in the experimental group.
Secondary Outcome Measures
Full Information
NCT ID
NCT05428813
First Posted
June 9, 2022
Last Updated
February 14, 2023
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT05428813
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Syndrome, Art, Women Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The group to which art therapy techniques will be applied.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The group that will continue their routine coping habits related to premenstrual syndrome.
Intervention Type
Behavioral
Intervention Name(s)
art therapy techniques
Intervention Description
Art therapy is a method that allows individuals to increase their self-awareness and realize their emotions better through artistic techniques.
Primary Outcome Measure Information:
Title
Techniques to be applied in the experimental group
Description
At the end of 8 weeks, improvement in premenstrual syndrome symptoms is expected in the experimental group.
Time Frame
It includes an 8-week process.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study will be conducted with female students with premenstrual syndrome.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tuğçe ÇİTİL, PhD
Organizational Affiliation
Kütahya Health Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kütahya Health Science University
City
Kütahya
ZIP/Postal Code
43000
Country
Turkey
12. IPD Sharing Statement
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The Effect of Art on Premenstrual Syndrome Symptoms
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