NCT07657429

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
May 2026Sep 2026

Study Start

First participant enrolled

May 30, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 14, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

Mandala ColoringMenopausePerceived StressMindfulnessWomen HealthRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Level

    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

Secondary Outcomes (2)

  • Menopause Attitude

    Baseline and 4 weeks after intervention

  • State Mindfulness

    Baseline and 4 weeks after intervention

Study Arms (2)

Mandala Intervention Group

EXPERIMENTAL

Participants in this group will receive mandala coloring sessions three times a week for four weeks in addition to routine care.

Behavioral: Mandala Coloring Program

Control Group

ACTIVE COMPARATOR

Participants in this group will receive routine care provided by the family health center without mandala coloring intervention.

Other: Routine Care

Interventions

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.

Mandala Intervention Group

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.

Control Group

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

12 No. Islampasa Family Health Center, Rize

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 39045964BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • NAZLI BALTACI, Assoc. Prof. Dr.

    Ondokuz Mayis University Faculty of Health Sciences

    STUDY CHAIR

Central Study Contacts

CEMRE ÇİLİNGİR, MSc Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the mandala coloring intervention group or the routine care control group in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Researcher

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.

Locations