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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05665972
Other study ID # KirklareliED-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date June 11, 2024

Study information

Verified date June 2024
Source Kirklareli University
Contact n/a
Is FDA regulated No
Health authority
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:

Occurs in the luteal phase and decreases or declines significantly with the onset of menstruation; physical such as breast tenderness, headache, bloating; Premenstrual syndrome is a health problem with more than 150 psychological and behavioral symptoms such as anger outbursts, irritability, anxiety, mood fluctuations, sleep and eating disorders. Symptoms experienced during the premenstrual period lead to results such as mood/affective disorder in women, deterioration in daily life activities and social relations, an increase in negative health behaviors, as well as low academic performance in students, decreased participation in classes, getting low grades in exams, and not showing up for exams.Since its etiology 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 mandala painting, one of the art therapy methods, through his own experience and that of his patients. Various studies have determined that mandala coloring improves physical and psychological symptoms, but no studies have been conducted with PMS.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 11, 2024
Est. primary completion date June 11, 2024
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.)

Study Design


Related Conditions & MeSH terms


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) Premenstrual Syndrome Scale is a 44-item Likert-type scale developed by Gencdogan to measure premenstrual symptoms and determine their severity. between one to six months
See also
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