- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665972
Effects of Mandala Coloring on Premenstrual Syndrome
Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Centre
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Kırklareli, Centre, Turkey, 39000
- Kırklareli University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mandala coloring group
Mandala painting will be applied to women suffering from premenstrual syndrome.
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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.
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No Intervention: Control group
Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Introductory Information Form
Time Frame: between one to six months
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The form consists of questions about socio-demographic and menstrual periods.
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between one to six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premenstrual Syndrome Scale (PMSS)
Time Frame: between one to six months
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Premenstrual Syndrome Scale is a 44-item Likert-type scale developed by Gencdogan to measure premenstrual symptoms and determine their severity.
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between one to six months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Efsun DERİN, Kırklareli University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KırklareliED-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premenstrual Syndrome
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Esra ÖZERKTO Karatay UniversityRecruitingPremenstrual Syndrome-PMSTurkey
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Shaare Zedek Medical CenterUnknownPremenstrual Syndrome-PMS
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Philipps University Marburg Medical CenterLinkoeping UniversityCompletedPremenstrual Syndrome (PMS)Germany
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Cairo UniversityNot yet recruitingPremenstrual Tension
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Cairo UniversityNot yet recruitingPremenstrual Pain
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Terra Biological LLCCompletedPremenstrual Syndrome (PMS)
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Massachusetts General HospitalWithdrawnPremenstrual Dysphoric Disorder | Premenstrual Syndrome | Premenstrual Tension | Menstrual Related Mood DisorderUnited States
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Tel-Aviv Sourasky Medical CenterUnknownDepression | Premenstrual Dysphoric Disorder (PMDD)Israel
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Yale UniversityNational Institute of Mental Health (NIMH)CompletedPremenstrual SyndromeUnited States
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