Premenstrual SyndromeNCT06144073
The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome
A study testing Intervention (Mandala art therapy) group in people with Premenstrual Syndrome, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Intervention (Mandala art therapy) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Oct 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziantep Islamic University of Science and Technology
Gaziantep
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
Official title: 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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Intervention (Mandala art therapy) group
- Keywords
- Premenstrual syndrome, Cope, Stress, Depression, Mandala
- Medical subject headings
- Premenstrual Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (Mandala art therapy) groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Mandala art therapy) group | Experimental | Students with premenstrual syndrome who were included in the mandala art therapy group by randomization method will be made to practice mandala. Receives: Behavioral: Intervention (Mandala art therapy) group |
| Control | No intervention | Control group is the group without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the level of premenstrual syndrome
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
"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.
Measured: 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
"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.
Measured: 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
"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.
Measured: 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 outcomes (6)
Determination of Perceived Stress Level
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.
Determination of Depression Level
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.
Measured: 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
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.
Measured: One month after the post-test, the Beck Depression Inventory is administered to all students in both groups as a follow-up assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start6 Oct 2022
- Primary completion29 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group (Mandala art therapy group) Control group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
- Investigators
- Esra KARATAŞ OKYAY, Principal investigator, Kahramanmaras Sutcu Imam UniversityZeynep BAL, PhD, Study director, Gaziantep Islam Science and Technology UniversityHatice POLAT, PhD, Study director, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144073
- Sponsor's protocol ID
- KSUESRAKARATASOKYAY002
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
Jang SH, Kim DI, Choi MS. Effects and treatment methods of acupuncture and herbal medicine for premenstrual syndrome/premenstrual dysphoric disorder: systematic review. BMC Complement Altern Med. 2014 Jan 10;14:11. doi: 10.1186/1472-6882-14-11.
PubMed 24410911
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06144073
- Acronym / sponsor ID
- KSUESRAKARATASOKYAY002
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, Cope, Stress, Depression, Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group (Mandala art therapy group) Control group
| Arm | Type | Receives |
|---|---|---|
| Intervention (Mandala art therapy) group | Experimental | Behavioral: Intervention (Mandala art therapy) groupStudents with premenstrual syndrome who were included in the mandala art therapy group by randomization method will be made to practice mandala. |
| Control | No intervention | –Control group is the group without any intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (Mandala art therapy) groupPersonal 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. | Behavioural | Intervention (Mandala art therapy) group |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 24410911Jang SH, Kim DI, Choi MS. Effects and treatment methods of acupuncture and herbal medicine for premenstrual syndrome/premenstrual dysphoric disorder: systematic review. BMC Complement Altern Med. 2014 Jan 10;14:11. doi: 10.1186/1472-6882-14-11.
- Description citation linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra KARATAŞ OKYAY principal investigator
Kahramanmaras Sutcu Imam University
Zeynep BAL, PhD study director
Gaziantep Islam Science and Technology University
Hatice POLAT, PhD study director
Malatya Turgut Ozal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Mandala art therapy) group in people with Premenstrual Syndrome, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.