An interventional study of Mandala coloring group in Premenstrual Syndrome, sponsored by Kırklareli University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Kırklareli University · Not applicable, Interventional, and Supportive care
Premenstrual syndrome (PMS) is a common condition among women of reproductive age and is characterized by a range of physical, psychological, and behavioral symptoms that may negatively affect daily functioning, social relationships, academic and occupational life, and psychological well-being. Anxiety and sleep disturbances are among the commonly reported problems associated with PMS. Mandala coloring, as an accessible and easy-to-use art-based activity that does not require specific skills, may promote psychological relaxation, reduce anxiety, and improve sleep quality. However, the effects of mandala coloring on sleep quality and anxiety among women experiencing PMS have not been directly investigated. Therefore, this clinical trial aims to evaluate the effect of a mandala coloring intervention on sleep quality and anxiety levels in women with PMS. The findings may provide evidence for the use of mandala coloring as a simple, accessible, and non-pharmacological approach to support the management of PMS-related symptoms.
Premenstrual syndrome (PMS) is a common condition among women of reproductive age, characterized by physical, psychological, and behavioral symptoms that may negatively affect quality of life, social and occupational functioning, sleep, and psychological well-being. Previous studies have demonstrated that PMS is associated with reduced sleep quality and increased anxiety. Non-pharmacological approaches, including art-based interventions, have recently gained attention as supportive strategies for managing PMS-related symptoms. Mandala coloring is a simple, accessible, and low-cost activity that does not require specific artistic skills and has been associated with reduced anxiety, stress, and psychological distress in previous studies.
Although previous research has examined the relationship between PMS, sleep quality, and anxiety, and other studies have investigated the potential benefits of art-based interventions, there is limited evidence regarding the direct effects of mandala coloring on sleep quality and anxiety among women with PMS. Therefore, this clinical trial aims to evaluate the effect of a structured mandala coloring intervention on sleep quality and anxiety levels in women experiencing PMS. The findings may provide evidence for a simple, accessible, and non-pharmacological approach that could support the management of PMS and contribute to women's health care.
177 studies on the registry are indexed under Premenstrual Syndrome; 32 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 154 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →Kırklareli University is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group will perform mandala coloring twice weekly for 20-30 minutes per session during the luteal phase of each menstrual cycle for three consecutive menstrual cycles. The intervention will begin approximately 14 days before the expected onset of menstruation and will be performed at a time of day chosen by the participant. Mandala templates and colored pencils will be provided by the researcher. Participants will send a brief message to the researcher before each session and share a photograph of the completed mandala afterward. Reminder messages will be sent twice weekly to support adherence. All of the three-cycle intervention period, participants will complete the Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), and State-Trait Anxiety Inventory (STAI) through an online questionnaire, requiring approximately 30-40 minutes.
Other: Mandala coloring group
Participants in the control group will not receive any mandala coloring intervention and will be asked to maintain their usual routines without initiating any pharmacological or non-pharmacological intervention aimed at reducing PMS symptoms. Their use of any PMS-related interventions will be monitored twice weekly by telephone throughout the three menstrual cycles. Participants in either group who initiate a pharmacological or non-pharmacological intervention for PMS symptoms during the study will be excluded. All of the of the three-cycle study period, participants will complete the Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), and State-Trait Anxiety Inventory (STAI) through an online questionnaire, requiring approximately 30-40 minutes. After completion of the study, participants will be informed about the mandala coloring intervention and those interested will be offered the opportunity to participate individually.
A mandala coloring intervention will be administered to individuals with PMS to evaluate its effects on anxiety reduction and sleep quality improvement.
Social demographic form
This form includes questions regarding women's sociodemographic characteristics, menstrual cycles, the presence of chronic diseases, menstrual symptoms, gynecological conditions, whether they have received prior education about menstruation, and whether they use pharmacological or non-pharmacological methods to alleviate premenstrual syndrome.
Time frame: between 2 to 4 weeks
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale (PMSS) is a 44-item, five-point Likert scale used to assess the severity of physical, emotional, and behavioral symptoms experienced before menstruation. Total scores range from 44 to 220, with higher scores indicating greater PMS symptom severity. A score above 50% of the maximum possible score (≥110) is considered indicative of PMS.
Time frame: between 2 to 12 weeks
State-Trait Scale (STAI-1, STAI-2)
State-Trait Anxiety Inventory (STAI) is used to assess individuals' state anxiety (temporary anxiety) and trait anxiety (general tendency toward anxiety). It consists of two 20-item subscales, each scored on a four-point Likert scale. Total scores for each subscale range from 20 to 80, with higher scores indicating higher anxiety levels.
Time frame: between 2 to 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a self-report instrument used to assess sleep quality and sleep disturbances over the previous month. It consists of 19 items covering seven components of sleep quality. Each component is scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score of ≥5 indicates poor sleep quality.
Time frame: between 2 to 12 weeks
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Kırklareli University