NCT06144073

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 26, 2025

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

November 16, 2023

Last Update Submit

June 23, 2025

Conditions

Keywords

Premenstrual syndromeCopeStressDepressionMandala

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.

  • Determination of Depression Level

    Three months after the first interview, the Beck Depression Inventory is administered as a pre-test to all students in both groups.

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Intervention (Mandala art therapy) group

Control

NO INTERVENTION

Control group is the group without any intervention.

Interventions

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.

Intervention (Mandala art therapy) group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziantep Islamic University of Science and Technology

Gaziantep, Turkey (Türkiye)

Location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 24410911BACKGROUND

Related Links

MeSH Terms

Conditions

Premenstrual SyndromeDepression

Interventions

MethodsPopulation Groups

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesDemographyPopulation Characteristics

Study Officials

  • Esra KARATAŞ OKYAY

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR
  • Zeynep BAL, PhD

    Gaziantep Islam Science and Technology University

    STUDY DIRECTOR
  • Hatice POLAT, PhD

    Malatya Turgut Ozal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention group (Mandala art therapy group) Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

October 6, 2022

Primary Completion

April 29, 2024

Study Completion

April 30, 2024

Last Updated

June 26, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

we don't share individual participant data with other researchers

Locations