- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144073
The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome
June 23, 2025 updated by: Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome: A Randomized Controlled Study
Mandala practice will be applied to women with premenstrual syndrome.
The intervention group (Mandala practice group) and the control group each consisted of 60 women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Materials and Methods: The randomized controlled trial was conducted between October 2022 and April 2024 with 120 students (60 intervention group and 60 control group) studying at Kahramanmaraş Sütçü İmam University and Gaziantep Islamic Science and Technology University, Faculty of Health Sciences, Department of Midwifery.
In the study, mandala art therapy is applied to the students in the intervention group.
The students will be informed about the method to be followed in the research, the voluntary information form will be read to those who want to participate in the research, and their verbal and written permission will be obtained.
Before the mandala art therapy, Personal Information Form, Premenstrual Syndrome Scale (PMSS), Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be applied to the students in both groups.
The students in the intervention group will be given mandala activity by the researcher two days a week for 12 weeks/total 24 times.
Three months after the first interview, Premenstrual Syndrome Scale (PMSÖ), Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be administered as a post-test.
One month after the end of the study, Premenstrual Syndrome Scale (PMS), Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be administered again as follow-up assessment.
The materials such as drawing paper, drawing and crayons required for mandala drawing in the study were provided by the researchers.
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
-
Gaziantep, Turkey
- Gaziantep Islamic University of Science and Technology
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Kahramanmaraş, Turkey
- Kahramanmaraş Sütçü İmam 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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being between the ages of 18-45
- Having a regular menstrual history between 21-35 days
- Score above 110 on the PMSÖ
- Not taking medical treatment for PMS,
- No history of psychiatric illness,
- No gynecological disease,
- No recent use of antidepressants, benzodiazepines/antipsychotics, combined oral contraceptives or hormones,
- Volunteering to participate in the study.
- Not having received mandala art therapy training before,
- Not having a physical problem that would prevent mandala production,
- Active use of hands,
- No communication problems,
- Speaking Turkish,
- Suitability/willingness to work in a group.
Exclusion Criteria:
- Having a diagnosis of psychiatric illness
- Having a diagnosis of chronic disease
- History of drug use
- Under 18 years of age
- Unable to communicate verbally,
- Giving birth in the last 3 months or breastfeeding,
- Pregnant,
- Have a history of psychiatric illness (diagnosis of moderate or severe depression, psychosis, bipolar illness, eating disorder, somatic symptom disorder, or acute suicidality),
- Gynecological disease (e.g. hysterectomy, oophorectomy, gynecological cancer, polycystic ovary syndrome, infertility, endometriosis)
- Recent use of antidepressants, benzodiazepines/antipsychotics, combined oral contraceptives or hormones,
- Having a physical problem that prevents you from creating a mandala,
- The student has a physical disability in the upper extremity,
- Previous mandala art therapy training
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: Intervention (Mandala art therapy) group
Students with premenstrual syndrome who were included in the mandala art therapy group by randomization method will be made to practice mandala.
|
Personal Information Form, Premenstrual Syndrome Scale, Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be applied to the students in both groups before mandala art therapy.
The students in the experimental group will be given mandala activity by the researcher two days a week for 12 weeks/total 24 times.
Three months after the first interview, Premenstrual Syndrome Scale, Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be administered as a post-test.
One month after the end of the study, Premenstrual Syndrome Scale, Coping with Premenstrual Change Scale, Perceived Stress Scale, Beck Depression Inventory will be applied again as follow-up evaluation.
|
|
No Intervention: Control
Control group is the group without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determining the level of premenstrual syndrome
Time Frame: At the first interview, the Premenstrual Syndrome Scale was applied to all students in both groups as a pre-test.
|
It is a five-point Likert-type scale consisting of 44 questions measuring the severity of premenstrual symptoms.
The scale has a total of nine sub-dimensions including Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Bloating.
The application of the premenstrual syndrome scale is carried out by retrospectively evaluating the person by taking into account the status of "being within one week before menstruation".
"PMSQ Total Score" is obtained from the sum of the scores obtained from all sub-dimensions.
A minimum of 44 and a maximum of 220 points can be obtained from the scale.
An increase in the score indicates an increase in the intensity of PMS symptoms.
|
At the first interview, the Premenstrual Syndrome Scale was applied to all students in both groups as a pre-test.
|
|
Determining the level of premenstrual syndrome
Time Frame: Three months after the first interview, the Premenstrual Syndrome Scale is administered as a pre-test to all students in both groups.
|
It is a five-point Likert-type scale consisting of 44 questions measuring the severity of premenstrual symptoms.
The scale has a total of nine sub-dimensions including Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Bloating.
The application of the premenstrual syndrome scale is carried out by retrospectively evaluating the person by taking into account the status of "being within one week before menstruation".
"PMSQ Total Score" is obtained from the sum of the scores obtained from all sub-dimensions.
A minimum of 44 and a maximum of 220 points can be obtained from the scale.
An increase in the score indicates an increase in the intensity of PMS symptoms.
|
Three months after the first interview, the Premenstrual Syndrome Scale is administered as a pre-test to all students in both groups.
|
|
Determining the level of premenstrual syndrome
Time Frame: One month after the post-test, the Premenstrual Syndrome Scale is administered to all students in both groups as a follow-up assessment.
|
It is a five-point Likert-type scale consisting of 44 questions measuring the severity of premenstrual symptoms.
The scale has a total of nine sub-dimensions including Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Bloating.
The application of the premenstrual syndrome scale is carried out by retrospectively evaluating the person by taking into account the status of "being within one week before menstruation".
"PMSQ Total Score" is obtained from the sum of the scores obtained from all sub-dimensions.
A minimum of 44 and a maximum of 220 points can be obtained from the scale.
An increase in the score indicates an increase in the intensity of PMS symptoms.
|
One month after the post-test, the Premenstrual Syndrome Scale is administered to all students in both groups as a follow-up assessment.
|
|
Identifying Coping with Premenstrual Change
Time Frame: At the first interview, the Coping with Premenstrual Change Scale was applied to all students in both groups as a pre-test.
|
"Coping with Premenstrual Change Scale (PMS-Coping)" It has 17 items and three sub-dimensions (Seeking Positive Affecting Behaviors, Seeking Support, Health Care Utilization Behavior).
The items of the scale are answered on a 4-point Likert scale.
The scale includes the options of "strongly disagree" (1 point), "not sure" (2 points), "agree" (3 points) and "strongly agree" (4 points).
The minimum score is 17 and the maximum score is 68.
In the instructions of the scale, it is asked to answer by thinking about the days before menstruation starts.
The scale is used to describe the methods used to cope with premenstrual change in women.
|
At the first interview, the Coping with Premenstrual Change Scale was applied to all students in both groups as a pre-test.
|
|
Identifying Coping with Premenstrual Change
Time Frame: Three months after the first interview, the Coping with Premenstrual Change Scale is administered as a pre-test to all students in both groups.
|
"Coping with Premenstrual Change Scale (PMS-Coping)" It has 17 items and three sub-dimensions (Seeking Positive Affecting Behaviors, Seeking Support, Health Care Utilization Behavior).
The items of the scale are answered on a 4-point Likert scale.
The scale includes the options of "strongly disagree" (1 point), "not sure" (2 points), "agree" (3 points) and "strongly agree" (4 points).
The minimum score is 17 and the maximum score is 68.
In the instructions of the scale, it is asked to answer by thinking about the days before menstruation starts.
The scale is used to describe the methods used to cope with premenstrual change in women.
|
Three months after the first interview, the Coping with Premenstrual Change Scale is administered as a pre-test to all students in both groups.
|
|
Identifying Coping with Premenstrual Change
Time Frame: One month after the post-test, the Coping with Premenstrual Change Scale is administered to all students in both groups as a follow-up assessment.
|
"Coping with Premenstrual Change Scale (PMS-Coping)" It has 17 items and three sub-dimensions (Seeking Positive Affecting Behaviors, Seeking Support, Health Care Utilization Behavior).
The items of the scale are answered on a 4-point Likert scale.
The scale includes the options of "strongly disagree" (1 point), "not sure" (2 points), "agree" (3 points) and "strongly agree" (4 points).
The minimum score is 17 and the maximum score is 68.
In the instructions of the scale, it is asked to answer by thinking about the days before menstruation starts.
The scale is used to describe the methods used to cope with premenstrual change in women.
|
One month after the post-test, the Coping with Premenstrual Change Scale is administered to all students in both groups as a follow-up assessment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of Perceived Stress Level
Time Frame: At the first interview, the Perceived Stress Level Scale was applied to all students in both groups as a pre-test.
|
The Perceived Stress Level Scale (PSL) consists of 14 items.
It was created to measure the extent to which people perceive certain situations in their lives as stressful.
The scale is a 5-point Likert-type scale (0: Never, 1: Almost Never, 2: Sometimes, 3: Frequently, 4: Very often).
The questions in the scale are aimed at evaluating the change in the participants' emotional state in the last one month.
The stress level perceived by the respondent is determined by summing the scores obtained from the items.
The scale has a total score between 0-56 points and the higher the score, the higher the perceived stress level.
|
At the first interview, the Perceived Stress Level Scale was applied to all students in both groups as a pre-test.
|
|
Determination of Perceived Stress Level
Time Frame: Three months after the first interview, the Perceived Stress Level Scale is administered as a pre-test to all students in both groups.
|
The Perceived Stress Level Scale (PSL) consists of 14 items.
It was created to measure the extent to which people perceive certain situations in their lives as stressful.
The scale is a 5-point Likert-type scale (0: Never, 1: Almost Never, 2: Sometimes, 3: Frequently, 4: Very often).
The questions in the scale are aimed at evaluating the change in the participants' emotional state in the last one month.
The stress level perceived by the respondent is determined by summing the scores obtained from the items.
The scale has a total score between 0-56 points and the higher the score, the higher the perceived stress level.
|
Three months after the first interview, the Perceived Stress Level Scale is administered as a pre-test to all students in both groups.
|
|
Determination of Perceived Stress Level
Time Frame: One month after the post-test, the Perceived Stress Level Scale is administered to all students in both groups as a follow-up assessment.
|
The Perceived Stress Level Scale (PSL) consists of 14 items.
It was created to measure the extent to which people perceive certain situations in their lives as stressful.
The scale is a 5-point Likert-type scale (0: Never, 1: Almost Never, 2: Sometimes, 3: Frequently, 4: Very often).
The questions in the scale are aimed at evaluating the change in the participants' emotional state in the last one month.
The stress level perceived by the respondent is determined by summing the scores obtained from the items.
The scale has a total score between 0-56 points and the higher the score, the higher the perceived stress level.
|
One month after the post-test, the Perceived Stress Level Scale is administered to all students in both groups as a follow-up assessment.
|
|
Determination of Depression Level
Time Frame: At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.
|
The Depression Inventory consists of 21 items, 15 of which include psychological and 6 somatic symptoms.
Although the inventory is a 4-point Likert-type inventory (scored between 0-3), it is used in various researches and clinical applications.
The highest score that can be obtained from the inventory is 63 and the lowest score is 0. A high total score indicates a high level of depression.
The cut-off point for clinical significance of depression is 17 points.
|
At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.
|
|
Determination of Depression Level
Time Frame: Three months after the first interview, the Beck Depression Inventory is administered as a pre-test to all students in both groups.
|
The Depression Inventory consists of 21 items, 15 of which include psychological and 6 somatic symptoms.
Although the inventory is a 4-point Likert-type inventory (scored between 0-3), it is used in various researches and clinical applications.
The highest score that can be obtained from the inventory is 63 and the lowest score is 0. A high total score indicates a high level of depression.
The cut-off point for clinical significance of depression is 17 points.
|
Three months after the first interview, the Beck Depression Inventory is administered as a pre-test to all students in both groups.
|
|
Determination of Depression Level
Time Frame: One month after the post-test, the Beck Depression Inventory is administered to all students in both groups as a follow-up assessment.
|
The Depression Inventory consists of 21 items, 15 of which include psychological and 6 somatic symptoms.
Although the inventory is a 4-point Likert-type inventory (scored between 0-3), it is used in various researches and clinical applications.
The highest score that can be obtained from the inventory is 63 and the lowest score is 0. A high total score indicates a high level of depression.
The cut-off point for clinical significance of depression is 17 points.
|
One month after the post-test, the Beck Depression Inventory is administered to all students in both groups as a follow-up assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Esra KARATAŞ OKYAY, Kahramanmaraş Sütçü İmam University
- Study Director: Zeynep BAL, PhD, Gaziantep Islam Science and Technology University
- Study Director: Hatice POLAT, PhD, Malatya Turgut Ozal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
October 6, 2022
Primary Completion (Actual)
April 29, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 26, 2025
Last Update Submitted That Met QC Criteria
June 23, 2025
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSUESRAKARATASOKYAY002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
we don't share individual participant data with other researchers
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.
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