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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: AYCA KIRCA, Phd
- Telefonnummer: 05392684185
- E-Mail: aycasolt@hotmail.com
Studienorte
-
-
-
Kırklareli, Türkei (türkiye)
- Kırklareli University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Social demographic form
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: AYCA KIRCA, Phd, Kırklareli University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KırklareliAS-16
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .