Effects of Mandala Coloring on Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665972
• Other study ID #: KirklareliED-2
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: December 2023
• Source: Kirklareli University
• Contact: Efsun DERIN
• Phone: +905469017922
• Email: efsunderinn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.

Description:

In the menstrual period, which starts with menarche and continues until menopause, which covers a significant part of a woman's life; It is seen that most women experience some physical, psychological and behavioral symptoms before menstruation. Premenstrual syndrome is a health problem that occurs in the luteal phase, decreases or regresses significantly with the onset of menstruation, and has more than 150 physical, psychological and behavioral symptoms such as breast tenderness, headache, anger outbursts, nervousness, anxiety, mood swings, eating disorders. In the first meta-analysis to determine the global prevalence of PMS, the worldwide prevalence of PMS was 47.8%. In studies conducted with university students in various countries, the prevalence of PMS varies between 39.8% and 98.2%. Symptoms experienced in the premenstrual period cause mood/affective disorder, deterioration in daily living activities and social relations, an increase in negative health behaviors in women, and also lead to results such as low academic performance, decreased participation in classes, getting low grades in exams, and absenteeism in exams. Since the etiology of premenstrual syndrome is unclear, no specific treatment method can be found and non-pharmacological therapies such as stress control, lifestyle changes, exercise and complementary therapies such as evening primrose oil, chasteberry and acupuncture are applied in its management. Psychiatrist Carl Gustav Jung discovered the psychic healing transformations created by painting mandala, one of the art therapy methods, through his own and his patients' experiences. Jung defined the mandala as the psychological expression of the unity of the self and believed that the mandala form represents psychic unity and integrity, and as a result, he made mandala coloring a part of his patients' therapeutic process.The repetitive pattern and symmetry of the mandala, which means circle in Sanskrit, is thought to have a healing and transformative effect along with meditative focus. Various studies have found that coloring mandala improves physical and psychological symptoms; It has been found to reduce anxiety and depression in cancer patients and children, pregnant women, and students. However, when the literature is examined, although studies such as yoga, swimming, aerobic exercise, acupressure, and music therapy have been conducted to improve PMS symptoms, no study has been found showing the effect of mandala coloring on PMS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the research
• Fully answering survey and scale forms.
• Ability to read and understand Turkish
• Being between the ages of 18 and 30 years
• Having regular menstruation (between 21 and 35 days)
• Having 45 or more from PMSS

Exclusion Criteria:

• Unwilling to continue working
• Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
• Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
• Having a chronic or physical illness
• Having a mental illness
• Being under psychiatric treatment (Pharmacotherapy or psychotherapy)
• Taking medication for menopausal symptoms
• Using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (COCs, acupressure, homeopathy, etc.)

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Mandala coloring
Each participant will be given 12 colored felt-tip pen paint sets and 12 mandala coloring pages by the researchers. Participants will be asked to dye for 3 menstrual cycles, 14 days before the start of menstruation, 1 day a week, at any time of the day and for an average of 20-30 minutes each time.

Locations

Country	Name	City	State
Turkey	Kirklareli University	Kirklareli	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Introductory Information Form	The form consists of questions about socio-demographic and menstrual periods.	between one to six months
Secondary	Premenstrual Syndrome Scale (PMSS)	The Premenstrual Syndrome Scale (PMSS) was developed by Gencdogan in 2006 to measure premenstrual symptoms and determine their severity. It is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points. PMSS; It consists of nine sub-dimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating. "PMSS Total Score" is obtained from the sum of all scores from the nine sub-dimensions of the scale. For the implementation of PMSS, the person is asked to make an evaluation by taking into account the "being within the period one week before menstruation". An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases.	between one to six months