Clinical trial NCT06144073: The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome
Official title: The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
Cope
Stress
Depression
Mandala
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (Mandala art therapy group) Control group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining the level of premenstrual syndrome
timeFrame: At the first interview, the Premenstrual Syndrome Scale was applied to all students in both groups as a pre-test.
measure: Determining the level of premenstrual syndrome
timeFrame: Three months after the first interview, the Premenstrual Syndrome Scale is administered as a pre-test to all students in both groups.
measure: Determining the level of premenstrual syndrome
timeFrame: One month after the post-test, the Premenstrual Syndrome Scale is administered to all students in both groups as a follow-up assessment.
measure: Identifying Coping with Premenstrual Change
timeFrame: At the first interview, the Coping with Premenstrual Change Scale was applied to all students in both groups as a pre-test.
measure: Identifying Coping with Premenstrual Change
timeFrame: Three months after the first interview, the Coping with Premenstrual Change Scale is administered as a pre-test to all students in both groups.
measure: Identifying Coping with Premenstrual Change
timeFrame: 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:
measure: Determination of Perceived Stress Level
timeFrame: At the first interview, the Perceived Stress Level Scale was applied to all students in both groups as a pre-test.
measure: Determination of Perceived Stress Level
timeFrame: Three months after the first interview, the Perceived Stress Level Scale is administered as a pre-test to all students in both groups.
measure: Determination of Perceived Stress Level
timeFrame: One month after the post-test, the Perceived Stress Level Scale is administered to all students in both groups as a follow-up assessment.
measure: Determination of Depression Level
timeFrame: At the first interview, the Beck Depression Inventory was applied to all students in both groups as a pre-test.
measure: Determination of Depression Level
timeFrame: Three months after the first interview, the Beck Depression Inventory is administered as a pre-test to all students in both groups.
measure: Determination of Depression Level
timeFrame: One month after the post-test, the Beck Depression Inventory is administered to all students in both groups as a follow-up assessment.
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islamic University of Science and Technology
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Esra KARATAŞ OKYAY
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziantep Islam Science and Technology University
name: Zeynep BAL, PhD
role: STUDY_DIRECTOR
affiliation: Malatya Turgut Özal University
name: Hatice POLAT, PhD
role: STUDY_DIRECTOR
References:
citation: 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.