The Effect of Mandala Coloring, Sleep Quality, Anxiety With Premenstrual Syndrome
The Effect of Mandala Coloring on Sleep Quality and Anxiety Levels in Students With Premenstrual Syndrome
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:AYCA KIRCA, Phd
- 电话号码:05392684185
- 邮箱:aycasolt@hotmail.com
学习地点
-
-
-
Kırklareli、土耳其(türkiye)
- Kırklareli University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Female students aged 18 and older
- Scoring 45 or higher on the Premenstrual Syndrome Scale
- Scoring 36 or higher on the State-Trait Anxiety Inventory (STAI)
- Scoring 5 or higher on the Pittsburgh Sleep Quality Index (PSQI)
- Having a regular menstrual cycle (21-35 days)
- Volunteering to participate in the study
- Fully completing the survey and scale forms
Exclusion Criteria:
- Not wishing to continue participating in the study
- Having any condition that hinders communication (such as impairments in hearing, speech, or comprehension)
- Having a gynecological condition (e.g., abnormal uterine bleeding, uterine fibroids, ovarian cysts, undergoing hormonal therapy)
- Having a chronic or physical illness
- Having a psychological disorder
- Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)
- Using pharmacological or non-pharmacological methods to alleviate premenstrual symptoms (e.g., oral contraceptives, acupressure, homeopathy, yoga)
- Having a sleep-related issue and receiving treatment for it
- Individuals who exercise regularly
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Mandala coloring group
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. |
A mandala coloring intervention will be administered to individuals with PMS to evaluate its effects on anxiety reduction and sleep quality improvement.
|
|
无干预:Control 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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Social demographic form
大体时间:between 2 to 4 weeks
|
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.
|
between 2 to 4 weeks
|
|
Premenstrual Syndrome Scale
大体时间:between 2 to 12 weeks
|
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.
|
between 2 to 12 weeks
|
|
State-Trait Scale (STAI-1, STAI-2)
大体时间:between 2 to 12 weeks
|
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.
|
between 2 to 12 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
大体时间:between 2 to 12 weeks
|
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.
|
between 2 to 12 weeks
|
合作者和调查者
调查人员
- 学习椅:AYCA KIRCA, Phd、Kırklareli University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.