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Effects of Mandala Coloring on Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mandala coloring
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual syndrome, Mandala coloring

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mandala coloring group

    Control group

    Arm Description

    Mandala painting will be applied to women suffering from premenstrual syndrome.

    Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms.

    Outcomes

    Primary Outcome Measures

    Introductory Information Form
    The form consists of questions about socio-demographic and menstrual periods.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    December 16, 2022
    Sponsor
    Kırklareli University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665972
    Brief Title
    Effects of Mandala Coloring on Premenstrual Syndrome
    Official Title
    Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2025 (Anticipated)
    Study Completion Date
    February 28, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırklareli University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.
    Detailed 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 (Biggs & Demuth, 2011; NAPS(The National Association for Premenstrual Syndromes),2018). Premenstrual syndrome (PMS) 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 (NAPS, 2018; BJOG(An International Journal of Obstetrics and Gynaecology), 2017). In the first meta-analysis to determine the global prevalence of PMS, the worldwide prevalence of PMS was 47.8% (Direkvand-Mogdahan et al.,2014). In studies conducted with university students in various countries, the prevalence of PMS varies between 39.8% and 98.2% (Ghani & Parveen, 2016; Cheng et al.,2013; Hussein Shehadeh & Hamdan-Mansour, 2018; Kim & Park, 2020; Seedhom et al.,2013). 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 (Dennerstein et al., 2010; Matsumoto et al., 2013; Tolossa & Bekele, 2014). 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 (NAPS, 2018; BJOG, 2017; ACOG(The American College of Obstetricians and Gynecologists), 2015). 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 (Davis, 2016).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 (Curry & Kasser, 2005; Brown & Ryan, 2003).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 (Store & Jakobsson, 2021; Flett et al., 2017; Gürcan & Atay Turan, 2021; Yakar et al., 2021; Amelia et al., 2020). 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 (Maged et al., 2018; Mohebbi et al., 2018; Şolt Kırca & Kızılkaya, 2022; Tsai, 2016; Armour et al., 2018).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Syndrome
    Keywords
    Premenstrual syndrome, Mandala coloring

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mandala coloring group
    Arm Type
    Experimental
    Arm Description
    Mandala painting will be applied to women suffering from premenstrual syndrome.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms.
    Intervention Type
    Other
    Intervention Name(s)
    Mandala coloring
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Introductory Information Form
    Description
    The form consists of questions about socio-demographic and menstrual periods.
    Time Frame
    between one to six months
    Secondary Outcome Measure Information:
    Title
    Premenstrual Syndrome Scale (PMSS)
    Description
    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.
    Time Frame
    between one to six months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Efsun DERIN
    Phone
    +905469017922
    Email
    efsunderinn@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayça ŞOLT KIRCA
    Phone
    +905392684185
    Email
    aycasolt@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Efsun DERİN
    Organizational Affiliation
    Kırklareli University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ayça ŞOLT KIRCA
    Organizational Affiliation
    Kırklareli University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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