- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428813
The Effect of Art on Premenstrual Syndrome Symptoms
February 14, 2023 updated by: Elif TUGCE CITIL, Kutahya Health Sciences University
The Effect of Art on Premenstrual Syndrome Symptoms: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kütahya, Turkey, 43000
- Kutahya Health Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
The group to which art therapy techniques will be applied.
|
Art therapy is a method that allows individuals to increase their self-awareness and realize their emotions better through artistic techniques.
|
|
No Intervention: Control
The group that will continue their routine coping habits related to premenstrual syndrome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Techniques to be applied in the experimental group
Time Frame: It includes an 8-week process.
|
At the end of 8 weeks, improvement in premenstrual syndrome symptoms is expected in the experimental group.
|
It includes an 8-week process.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
June 9, 2022
First Submitted That Met QC Criteria
June 17, 2022
First Posted (Actual)
June 23, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-41997688-050.99-40210
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premenstrual Syndrome
-
Haleema SadiaCompletedPremenstrual Syndrome-PMSPakistan
-
Esra ÖZERKTO Karatay UniversityCompletedPremenstrual Syndrome-PMSTurkey
-
University of Health Sciences LahoreActive, not recruitingPremenstrual Syndrome-PMSPakistan
-
Shaare Zedek Medical CenterUnknownPremenstrual Syndrome-PMS
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingMenstrual Cycle | Premenstrual Syndrome | Premenstrual Syndrome-PMS | PMDD | Premenstrual Dysphoric Disorder (PMDD)United States
-
Cairo UniversityNot yet recruitingPremenstrual Tension
-
Cairo UniversityNot yet recruitingPremenstrual Pain
-
Activ'insideActive, not recruitingPremenstrual Syndrome-PMSItaly
-
Izmir Democracy UniversityEnrolling by invitationPremenstrual Syndrome-PMSTurkey
-
Philipps University Marburg Medical CenterLinkoeping UniversityCompletedPremenstrual Syndrome (PMS)Germany
Clinical Trials on art therapy techniques
-
Kevser PamukCompletedOvarian Cancer | Cervix Cancer | Endometrial Cancer | Grief | Uterine Cancer | Vulva Cancer | FemininityTurkey
-
Medical University of South CarolinaNational Endowment for the Arts, United StatesActive, not recruitingPhysical Therapy | Hematopoietic Stem Cell Transplantation | Art TherapyUnited States
-
KAVADIA ELENICompletedDepressive Disorder | Schizophrenia | Anxiety Disorders | Emotional Disorder | Autism | Mental Health IssueGreece
-
King Abdullah University HospitalCompletedPTSD - Post Traumatic Stress DisorderJordan
-
Lisa GallagherThe Cleveland Clinic; National Endowment for the Arts, United States; Cuyahoga...TerminatedDepression | Heart Diseases | Stroke | Multiple Sclerosis | Hypertension | Obesity | Diabetes | Chronic Pain | Asthma | Anxiety | COPD | CHF | High CholesterolUnited States
-
IFM International Forest MedicineCompletedComplementary Therapies | Preventive Medicine | Mindfulness | Stress (Psychology) | Mind-Body Therapies | Well-Being, PsychologicalSpain
-
Dokuz Eylul UniversityRecruitingAnxiety | Sleep Disturbance | Colorectal Cancer (Diagnosis)Turkey (Türkiye)
-
Hampton VA Medical CenterTerminatedPost-traumatic Stress Disorder | Stress Disorder, Post-TraumaticUnited States
-
University of ZurichRecruitingPosttraumatic Stress Disorder | Pancreas Cancer | Depression, Anxiety | Lower Gastrointestinal Neoplasms BenignSwitzerland