MenopauseMANDALA-MENONCT07657429
Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness
A study testing Mandala Coloring Program and Routine Care in people with Menopause and Psychological Stress, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopause, Psychological Stress, Mindfulness
- What is being tested?
- Mandala Coloring Program and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
12 No. Islampasa Family Health Center, Rize
Rize, Rize Province, 53020
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause, Psychological Stress, Mindfulness
- Being tested
- Mandala Coloring Program, Routine Care
- Keywords
- Mandala Coloring, Menopause, Perceived Stress, Mindfulness, Women Health, Randomized Controlled Trial
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Coloring ProgramBehavioural
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.
Routine CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks after intervention
Secondary outcomes (2)
Menopause Attitude
Changes in attitudes toward menopause will be assessed using the Menopause Attitude Scale. Higher scores reflect more positive attitudes toward menopause.
Measured: Baseline and 4 weeks after intervention
State Mindfulness
Changes in mindfulness levels will be assessed using the State Mindfulness Scale. Higher scores indicate greater mindfulness awareness.
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the mandala coloring intervention group or the routine care control group in parallel.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Çilingir, Ondokuz Mayıs University
- Investigators
- NAZLI BALTACI, Assoc. Prof. Dr., Study chair, Ondokuz Mayis University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657429
- Sponsor's protocol ID
- OMU-MANDALA-2026
- Acronym
- MANDALA-MENO
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.
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.
PubMed 39045964
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Menopausal Attitudes, Perceived Stress, and Mindfulness in Women During Menopause: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07657429
- Acronym / sponsor ID
- MANDALA-MENO / OMU-MANDALA-2026
- Conditions
- Menopause, Psychological Stress, Mindfulness
- Keywords
- Mandala Coloring, Menopause, Perceived Stress, Mindfulness, Women Health, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the mandala coloring intervention group or the routine care control group in parallel.
| Arm | Type | Receives |
|---|---|---|
| Mandala Intervention Group | Experimental | Behavioral: Mandala Coloring ProgramParticipants in this group will receive mandala coloring sessions three times a week for four weeks in addition to routine care. |
| Control Group | Active comparator | Other: Routine CareParticipants in this group will receive routine care provided by the family health center without mandala coloring intervention. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala Coloring ProgramParticipants 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. | Behavioural | Mandala Intervention Group |
| Routine CareParticipants 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. | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
Menopause Attitude
Time frame: Baseline and 4 weeks after intervention
State Mindfulness
Time frame: Baseline and 4 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 39045964Kirca 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and ethical restrictions related to participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NAZLI BALTACI, Assoc. Prof. Dr. study chair
Ondokuz Mayis University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring Program and Routine Care in people with Menopause and Psychological Stress, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CEMRE ÇİLİNGİR, MSc Student (+90 536 274 36 46, cemrecilingir3103@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Level (time frame: Baseline and 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.