AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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,
Show all 14Show fewer
  • 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,
Show all 13Show fewer
  • 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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06144073
Study groupRoleWhat they receive
Intervention (Mandala art therapy) groupExperimentalStudents 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
ControlNo interventionControl group is the group without any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  1. First posted22 Nov 2023
  2. Study start6 Oct 2022
  3. Primary completion29 Apr 2024
  4. Study completion30 Apr 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in