Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07785622

The Effect of Mandala Coloring, Sleep Quality, Anxiety With Premenstrual Syndrome

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Premenstrual Syndrome Anxiety Disorders Menstruation Disturbances Mental Disorders Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli University

Kırklareli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandala coloring group

Other

A mandala coloring intervention will be administered to individuals with PMS to evaluate its effects on anxiety reduction and sleep quality improvement.

Primary outcomes

  1. Social demographic form

    Time frame: 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.

  2. Premenstrual Syndrome Scale

    Time frame: 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.

  3. State-Trait Scale (STAI-1, STAI-2)

    Time frame: 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.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

AYCA KIRCA, Phd

CONTACT

[email protected]

05392684185

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Registry information

Official study title

The Effect of Mandala Coloring on Sleep Quality and Anxiety Levels in Students With Premenstrual Syndrome

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.