The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144073
• Other study ID #: KSUESRAKARATASOKYAY002
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Kahramanmaras Sutcu Imam University
• Contact: Esra KARATAS OKYAY, PhD
• Phone: 05432125225
• Email: esrakaratas44[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Behavioral:
• Intervention (Mandala art therapy) group
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.

Locations

Country	Name	City	State
Turkey	Gaziantep Islamic University of Science and Technology	Gaziantep
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	At the first interview, the Perceived Stress Level Scale was applied to all students in both groups as a pre-test.
Secondary	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.	Three months after the first interview, the Perceived Stress Level Scale is administered as a pre-test to all students in both groups.
Secondary	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.	One month after the post-test, the Perceived Stress Level Scale is administered to all students in both groups as a follow-up assessment.
Secondary	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.	At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.
Secondary	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.	Three months after the first interview, the Beck Depression Inventory is administered as a pre-test to all students in both groups.
Secondary	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.	One month after the post-test, the Beck Depression Inventory is administered to all students in both groups as a follow-up assessment.

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