- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07657429
Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness (MANDALA-MENO)
24. juni 2026 opdateret af: Cemre Çilingir, Ondokuz Mayıs University
The Effect of Mandala Coloring on Menopausal Attitudes, Perceived Stress, and Mindfulness in Women During Menopause: A Randomized Controlled Trial
Menopause is a natural life stage associated with hormonal changes that may affect women physically and psychologically.
During this period, women may experience increased stress levels, negative attitudes toward menopause, and decreased mindfulness.
Mandala coloring is a structured art-based intervention that may promote relaxation and improve psychological well-being.
This randomized controlled trial aims to evaluate the effect of mandala coloring on attitudes toward menopause, perceived stress, and mindfulness levels among menopausal women.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Menopause is a natural stage of life characterized by hormonal changes that may affect women's physical and psychological well-being.
During this period, women may experience vasomotor symptoms, sleep disturbances, mood changes, increased stress, and negative attitudes toward menopause.
Supporting women's psychological well-being during menopause has become an important aspect of women's health care.Mindfulness-based and art-based interventions have increasingly been used as non-pharmacological approaches to improve psychological health and reduce stress.
Mandala coloring is a structured art-based intervention that promotes concentration, helps individuals focus on the present moment, and may contribute to emotional regulation and relaxation.
Previous studies have shown that mandala coloring may reduce anxiety and stress levels while improving overall well-being.This study will be conducted as a parallel-group randomized controlled experimental trial.
The study will take place at Islampasa Family Health Center No.12 located in Rize, Türkiye.
A total of 140 menopausal women aged between 45 and 55 years who meet the eligibility criteria will be included in the study.Participants will be randomly assigned to either an intervention group or a control group using a web-based randomization procedure.
Women assigned to the intervention group will participate in structured mandala coloring sessions for four weeks, three times per week, for a total of 12 sessions.
The first session will be conducted face-to-face at the family health center under researcher supervision.
The remaining sessions will be completed individually by participants at home during evening hours.Participants in the control group will receive routine care provided at the family health center without any additional intervention.Data will be collected before and after the intervention using the Personal Information Form, Menopause Attitude Scale, Perceived Stress Scale, and State Mindfulness Scale.The primary purpose of this study is to determine whether structured mandala coloring has an effect on attitudes toward menopause, perceived stress, and mindfulness levels in menopausal women.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: CEMRE ÇİLİNGİR, MSc Student
- Telefonnummer: +90 536 274 36 46
- E-mail: cemrecilingir3103@gmail.com
Studiesteder
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Rize Province
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Rize, Rize Province, Tyrkiet (Türkiye), 53020
- 12 No. Islampasa Family Health Center, Rize
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Women aged 45-55 years
- Being in the menopausal period (absence of menstruation for at least 12 months)
- Ability to read and understand Turkish
- Voluntary agreement to participate in the study
Exclusion Criteria:
- Diagnosed psychiatric or cognitive disorders
- Communication problems preventing participation
- Visual impairment or fine motor limitations preventing mandala coloring
- Use of hormone replacement therapy
- Regular participation in mandala coloring, mindfulness, or similar mind-body practices
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Mandala Intervention Group
Participants in this group will receive mandala coloring sessions three times a week for four weeks in addition to routine care.
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Participants in the intervention group will receive a mandala coloring program for 4 weeks.
The program will be performed 3 times per week, for a total of 12 sessions.
The first session will be conducted face-to-face at the family health center, and the remaining sessions will be completed at home.
Participants will use standardized mandala templates and coloring materials provided by the researchers.
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Aktiv komparator: Control Group
Participants in this group will receive routine care provided by the family health center without mandala coloring intervention.
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Participants in the control group will receive routine care provided by the family health center.
This includes general health monitoring, menopausal health counseling, and standard follow-up services without any mandala coloring intervention during the study period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived Stress Level
Tidsramme: Baseline and 4 weeks after intervention
|
Changes in perceived stress levels of menopausal women will be assessed using the Perceived Stress Scale (PSS-10).
Higher scores indicate higher perceived stress.
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Baseline and 4 weeks after intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Menopause Attitude
Tidsramme: Baseline and 4 weeks after intervention
|
Changes in attitudes toward menopause will be assessed using the Menopause Attitude Scale.
Higher scores reflect more positive attitudes toward menopause.
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Baseline and 4 weeks after intervention
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State Mindfulness
Tidsramme: Baseline and 4 weeks after intervention
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Changes in mindfulness levels will be assessed using the State Mindfulness Scale.
Higher scores indicate greater mindfulness awareness.
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Baseline and 4 weeks after intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: NAZLI BALTACI, Assoc. Prof. Dr., Ondokuz Mayis University Faculty of Health Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. maj 2026
Primær færdiggørelse (Anslået)
30. september 2026
Studieafslutning (Anslået)
30. september 2026
Datoer for studieregistrering
Først indsendt
14. juni 2026
Først indsendt, der opfyldte QC-kriterier
14. juni 2026
Først opslået (Faktiske)
18. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMU-MANDALA-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.
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