NCT07332065

Brief Summary

The aim of this clinical study is to determine the effect of mandala coloring on menopausal symptoms, sexual quality of life, and self-esteem in women during menopause period. The main questions the study aims to answer are as follows:

  • Participants in the intervention group will attend 30-minute mandala coloring sessions once a week for 4 weeks.
  • Participants in the control group will not receive any intervention during the same period.
  • Both groups will be assessed using a questionnaire at the beginning of the study and at the end of the 4th week (pre-test/post-test).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

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 Progress71%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

December 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 11, 2025

Last Update Submit

December 31, 2025

Conditions

Keywords

menopausemenopause symptomsself esteemmandala coloringsexual quality of lifemandala

Outcome Measures

Primary Outcomes (1)

  • Menopausal Symptoms

    The primary outcome measure in this study is the severity of menopausal symptoms as assessed by the Menopause Rating Scale. This scale is an 11-item measure developed by Heineman et al. (1996) to assess the severity of menopausal symptoms. The minimum score that can be obtained on the scale is 0, while the maximum score is 44. An increase in the score obtained from the scale indicates an increase in the severity of the complaints experienced, while also showing that quality of life has been negatively affected. In this study, the validity and reliability of the scale in Turkish were conducted by Can Gürkan (2005). The Turkish version of the scale will be used. Within the scope of the current study, it is expected that women in menopause who engage in mandala coloring will show improvement in menopause symptoms. In other words, the Menopause Rating Scale scores of women in the experimental group will be lower than those of women who do not practice mandala coloring.

    Time Frame: Fromenrollmenttotheend of intervention at 4 weeks.

Secondary Outcomes (2)

  • Sexual Quality Of Life

    Time Frame: From enrollment to the end of intervention at 4 weeks.

  • Self-Esteem

    Time Frame: From enrollment to the end of intervention at 4 weeks.

Study Arms (2)

Mandala coloring

EXPERIMENTAL

Participants will take part in 30-minute mandala painting sessions once a week for four weeks.

Other: Mandala coloring

Control group

NO INTERVENTION

No intervention will be applied to participants in the control group within 4 weeks.

Interventions

Mandala coloring is a structured creative art activity based on colouring mandala shapes, which consist of circular and symmetrical patterns, increasing focus and promoting relaxation. As one of the art therapies, mandala colouring can have a therapeutic effect on individuals.

Also known as: Mandala art activity
Mandala coloring

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale gender is suitable as the study is on menopausal symptoms.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 40 and 65,
  • Not having experienced menstruation for at least one year,
  • Having a score of 15 or higher on the MSDS (meaning having experienced at least moderate menopause),
  • Not having received hormone replacement therapy for menopausal symptoms,
  • Not having undergone surgical menopause,
  • Experiencing at least one vasomotor symptom of menopause (hot flashes, night sweats, sudden sweating attacks, palpitations, chills and shivering attacks, etc.).
  • Being able to read, write, speak, and understand Turkish,
  • Not having previously received mandala art therapy training or regularly practicing mandala coloring,
  • Not having an allergy to mandala coloring materials,
  • Not practicing spiritual practices such as yoga or meditation,
  • Agreeing to participate in the study.

You may not qualify if:

  • Having a physical symptom that may prevent mandala coloring,
  • Having communication and perception problems,
  • Having difficulty understanding or speaking Turkish,
  • Having a psychiatric illness or taking psychiatric medication,
  • Having experienced a loss in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Kevser Katkaya, Bachelor's Degree in Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2025

First Posted

January 12, 2026

Study Start

January 20, 2026

Primary Completion

February 20, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share