- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07657429
Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness (MANDALA-MENO)
24 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
140
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: CEMRE ÇİLİNGİR, MSc Student
- Telefonnummer: +90 536 274 36 46
- E-post: cemrecilingir3103@gmail.com
Studieorter
-
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Rize Province
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Rize, Rize Province, Turkiet (Türkiye), 53020
- 12 No. Islampasa Family Health Center, Rize
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Mandala Intervention Group
Participants in this group will receive mandala coloring sessions three times a week for four weeks in addition to routine care.
|
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.
|
|
Aktiv komparator: Control Group
Participants in this group will receive routine care provided by the family health center without mandala coloring intervention.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived Stress Level
Tidsram: 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.
|
Baseline and 4 weeks after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Menopause Attitude
Tidsram: 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.
|
Baseline and 4 weeks after intervention
|
|
State Mindfulness
Tidsram: Baseline and 4 weeks after intervention
|
Changes in mindfulness levels will be assessed using the State Mindfulness Scale.
Higher scores indicate greater mindfulness awareness.
|
Baseline and 4 weeks after intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: NAZLI BALTACI, Assoc. Prof. Dr., Ondokuz Mayis University Faculty of Health Sciences
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 maj 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
30 september 2026
Studieregistreringsdatum
Först inskickad
14 juni 2026
Först inskickad som uppfyllde QC-kriterierna
14 juni 2026
Första postat (Faktisk)
18 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OMU-MANDALA-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .