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Not yet recruiting NCT07657429

Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness

No phase Interventional Menopause Psychological Stress Mindfulness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mandala Coloring Program, Routine Care.
Who it may be relevant to
Registry conditions: Menopause, Psychological Stress, Mindfulness. Basic parameters: 45 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Mandala Coloring on Menopausal Attitudes, Perceived Stress, and Mindfulness in Women During Menopause: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Mandala Coloring Program
    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.
  • Other Routine Care
    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.

Primary outcome measures

  • Perceived Stress Level [Time frame: Baseline and 4 weeks after intervention]
Secondary outcome measures (2)
  • Menopause Attitude [Time frame: Baseline and 4 weeks after intervention]
  • State Mindfulness [Time frame: Baseline and 4 weeks after intervention]

Eligibility criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • 12 No. Islampasa Family Health Center, Rize — Rize

Publications

  • Kirca AS, Dagli E, Derin E, Aka N. The effect of mandala coloring on anxiety and quality of life of women in the climacteric period: a randomized controlled study. Rev Assoc Med Bras (1992). 2024 Jul 19;70(6):e20240059. doi: 10.1590/1806-9282.20240059. eCollection 2024. PMID 39045964

Identifiers

NCT: NCT07657429 · OMU-MANDALA-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗