- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07657429
Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness (MANDALA-MENO)
June 24, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CEMRE ÇİLİNGİR, MSc Student
- Phone Number: +90 536 274 36 46
- Email: cemrecilingir3103@gmail.com
Study Locations
-
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Rize Province
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Rize, Rize Province, Turkey (Türkiye), 53020
- 12 No. Islampasa Family Health Center, Rize
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Level
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menopause Attitude
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: NAZLI BALTACI, Assoc. Prof. Dr., Ondokuz Mayis University Faculty of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 30, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
June 14, 2026
First Submitted That Met QC Criteria
June 14, 2026
First Posted (Actual)
June 18, 2026
Study Record Updates
Last Update Posted (Actual)
June 29, 2026
Last Update Submitted That Met QC Criteria
June 24, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMU-MANDALA-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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