Menopause Symptom ManagementNCT07149285
Effect of Mandala Practice on Menopausal Symptoms and Quality of Life
A study testing Mandala coloring in people with Menopause Symptom Management and Quality of Life, run by Emine Karacan at 1 site in Turkey (Türkiye).
Trial summary
Menopause is a natural cycle of life that mostly develops due to changes in the endocrine glands of the female body during middle age, and the menstrual cycle is permanently interrupted as a result of the ovaries losing their activity. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Menopause Symptom Management, Quality of Life, Menopausal Symptoms
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2025to Oct 2025
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study included women who met the following conditions:
- Absence of cognitive, hearing, or speech impairments that could interfere with effective communication,
- No physical, psychological, or visual limitations that could hinder participation in mandala coloring activities,
- Literacy in Turkish, including the ability to read, comprehend, and write,
- A confirmed medical diagnosis of menopause,
- Not undergoing any form of psychotherapy or alternative treatment throughout the study period,
- Voluntary participation with signed informed consent.
Who cannot join
- Participants were excluded from the study if they:
- Provided incomplete or inaccurate responses in the data collection forms,
- Were receiving hormone therapy to manage menopausal symptoms,
- Had a neurological disorder that could impair concentration or communication during the mandala activity,
- Had known allergies to paints or similar substances.
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
Private Palmiye Hospital, Gynecology and Obstetrics Clinic
Hatay, İskenderun
Emine Karacan, Asst Prof, +90 537 214 83 75, emine.karacan@gibtu.edu.tr
Emine Karacan, Asst Prof, +90 530 035 04 14, emine.karacan@iste.edu.tr
About this study
Menopause is a natural cycle of life that mostly develops due to changes in the endocrine glands of the female body during middle age, and the menstrual cycle is permanently interrupted as a result of the ovaries losing their activity. Many symptoms are observed in women during menopause, and these symptoms cause women to experience many physiological, mental, social and sexual problems in the short or long term and to deteriorate their quality of life. In reducing the menopause symptoms experienced by women, hormone replacement therapy, traditional methods, mental or physical applications; aromatherapy, hypnosis, Biofeedback and relaxation techniques are used. The aim of these applications; is to relax women, reduce menopausal symptoms and increase their quality of life. Mandala, which has been widely used in the field of therapy in the past and today, is seen as a meditation tool in art therapy and is defined as a complementary, safe and accessible activity that supports mental health. It has been determined that how the mandala method, which is used in many areas in the literature, affects the symptoms and quality of life of women in the menopausal period has not been examined. For this reason, it is thought that this study will make a significant contribution to the literature.
Read the detailed description
This study was designed as a randomized controlled experimental trial to examine the effects of mandala practice on menopausal symptoms and quality of life. The study will be conducted with 78 women (experimental = 39, control = 39) diagnosed with menopause at the Private Palmiye Hospital Gynecology and Obstetrics Outpatient Clinics. Participants will be randomly assigned to groups via random.org. Women in the experimental group will practice mandala coloring for 20-30 minutes daily for 15 days, while the control group will only be administered the scales and will be advised to practice mandala practice at the end of the study due to ethical principles. Data will be collected using a Personal Information Form, the Menopause Symptoms Assessment Scale, the Menopause-Specific Quality of Life Scale, and the Mandala Practice Follow-up Form. Data will be analyzed using frequency, descriptive statistics, the Shapiro-Wilks normality test, the independent samples t-test, one-way analysis of variance, and the Pearson correlation test in SPSS 24.0. It is anticipated that the findings of the study will make a significant contribution to the literature by revealing the effect of mandala practice in reducing symptoms and improving quality of life in menopausal women.
- Being tested
- Mandala coloring
- Keywords
- menopause, mandala painting, menopausal symptoms, quality of life, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Intervention Group:
The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied. Participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the process, the scales will be re-applied and the follow-up forms will be collected. Their routine treatments will continue.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention Group: Women diagnosed with menopause will be invited to the study through face-to-face interviews at the outpatient clinic. Information will be provided about the study and the mandala application; women who agree to participate in the study will be asked to fill out an informed consent form, personal information form, menopause symptoms and menopause-specific quality of life assessment scales. Sample mandalas, blank mandalas, 12 different color crayons and a mandala application follow-up form will be distributed to the participants. The mandala application will be performed by the participants for 20-30 minutes every day for 15 days. In the interim periods (every other day), the application will be monitored by phone. At the end of the 15th day, the participants will be interviewed face-to-face again, the follow-up form will be collected and the menopause symptoms and quality of life scales will be re-administered. Receives: Other: Mandala coloring |
| The control group | No intervention | The control group will be informed about the study in face-to-face interviews with women who applied to the outpatient clinic and were diagnosed with menopause, and women who agreed to participate in the study will be given an informed consent form, a personal information form, and menopause-specific quality of life and menopause symptom assessment scales and asked to fill them out. The women will be interviewed again 15 days later and given the menopause-specific quality of life and menopause symptom assessment scales again and asked to fill them out. In addition, the benefits of the mandala application will be explained to the women in order to eliminate the ethical dilemma, and coloring pencils with mandalas will be given to women who want to do the application. The women's routine care and treatments will continue during the data collection period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal Symptoms Assessment Scale (MSAS) total score
Evaluation of the effect of mandala practice on the severity of somatic, psychological and urogenital symptoms in menopausal women. The MSAS consists of 11 items and three subscales. The subscales are labeled "Somatic Complaints," "Psychological Complaints," and "Urogenital Complaints." The scale is answered on a 5-point Likert-type scale, with each item scored as follows: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Extremely severe. The lowest possible score for the entire scale is 0, and the highest is 44. A higher total score indicates an increase in the severity of the complaints and a negative impact on quality of life.
Measured: Pre-intervention (day 0) and post-intervention (day 15)
Secondary outcomes (1)
Menopause-Specific Quality of Life Scale (MSQL) total and sub-dimension scores
Evaluation of the effect of mandala practice on the quality of life (vasomotor, psychosocial, physical and sexual dimensions) of menopausal women. The scale consists of four domains: vasomotor, psychosocial, physical, and sexual. It contains 29 Likert-type statements. As the score increases, the severity of the complaint and the quality of life decrease. Because the total scale uses an average score, the lowest possible score is 0, and the highest is 6. Each subdomain on the MSQL is scored from 0 to 6. A score of "0" indicates that no problem is experienced. A score of "1" indicates that the problem exists, but it is not bothersome at all. Scores between "2 and 6" indicate the severity and increasing severity of the problem.
Measured: Pre-intervention (day 0) and post-intervention (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Symptom ManagementStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied (Pre-test). Then, participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the process, the scales will be re-applied (post-test) and the follow-up forms will be collected. Control Group: After the participants are informed about the study and their consent is obtained, the same scales will be applied (Pre-test). They will be interviewed again 15 days later and the scales will be filled out again (Post-test). Mandalas and pencils will be given to those who want them at the end of the study for ethical reasons.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emine Karacan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Karacan, Gaziantep Islam Science and Technology University
- Investigators
- Emine Karacan, Asst Prof, Study chair, Gaziantep Islamic Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149285
- Sponsor's protocol ID
- Protocol No:2025/523
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share individual participant data collected in this study. This is because participant privacy was not protected and explicit consent for data sharing was not obtained. In addition, due to the sensitive nature of the data and ethical responsibilities, it was not deemed appropriate to share it with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mandala Practice on Menopausal Symptoms and Quality of Life
- ClinicalTrials.gov ID
- NCT07149285
- Acronym / sponsor ID
- Protocol No:2025/523
- Keywords
- menopause, mandala painting, menopausal symptoms, quality of life, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Emine KaracanUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Aug 2025 (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 cycle of life that mostly develops due to changes in the endocrine glands of the female body during middle age, and the menstrual cycle is permanently interrupted as a result of the ovaries losing their activity. Many symptoms are observed in women during menopause, and these symptoms cause women to experience many physiological, mental, social and sexual problems in the short or long term and to deteriorate their quality of life. In reducing the menopause symptoms experienced by women, hormone replacement therapy, traditional methods, mental or physical applications; aromatherapy, hypnosis, Biofeedback and relaxation techniques are used. The aim of these applications; is to relax women, reduce menopausal symptoms and increase their quality of life. Mandala, which has been widely used in the field of therapy in the past and today, is seen as a meditation tool in art therapy and is defined as a complementary, safe and accessible activity that supports mental health. It has been determined that how the mandala method, which is used in many areas in the literature, affects the symptoms and quality of life of women in the menopausal period has not been examined. For this reason, it is thought that this study will make a significant contribution to the literature.
Detailed description
This study was designed as a randomized controlled experimental trial to examine the effects of mandala practice on menopausal symptoms and quality of life. The study will be conducted with 78 women (experimental = 39, control = 39) diagnosed with menopause at the Private Palmiye Hospital Gynecology and Obstetrics Outpatient Clinics. Participants will be randomly assigned to groups via random.org. Women in the experimental group will practice mandala coloring for 20-30 minutes daily for 15 days, while the control group will only be administered the scales and will be advised to practice mandala practice at the end of the study due to ethical principles. Data will be collected using a Personal Information Form, the Menopause Symptoms Assessment Scale, the Menopause-Specific Quality of Life Scale, and the Mandala Practice Follow-up Form. Data will be analyzed using frequency, descriptive statistics, the Shapiro-Wilks normality test, the independent samples t-test, one-way analysis of variance, and the Pearson correlation test in SPSS 24.0. It is anticipated that the findings of the study will make a significant contribution to the literature by revealing the effect of mandala practice in reducing symptoms and improving quality of life in menopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group: The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied (Pre-test). Then, participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the process, the scales will be re-applied (post-test) and the follow-up forms will be collected. Control Group: After the participants are informed about the study and their consent is obtained, the same scales will be applied (Pre-test). They will be interviewed again 15 days later and the scales will be filled out again (Post-test). Mandalas and pencils will be given to those who want them at the end of the study for ethical reasons.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mandala coloringIntervention Group: Women diagnosed with menopause will be invited to the study through face-to-face interviews at the outpatient clinic. Information will be provided about the study and the mandala application; women who agree to participate in the study will be asked to fill out an informed consent form, personal information form, menopause symptoms and menopause-specific quality of life assessment scales. Sample mandalas, blank mandalas, 12 different color crayons and a mandala application follow-up form will be distributed to the participants. The mandala application will be performed by the participants for 20-30 minutes every day for 15 days. In the interim periods (every other day), the application will be monitored by phone. At the end of the 15th day, the participants will be interviewed face-to-face again, the follow-up form will be collected and the menopause symptoms and quality of life scales will be re-administered. |
| The control group | No intervention | –The control group will be informed about the study in face-to-face interviews with women who applied to the outpatient clinic and were diagnosed with menopause, and women who agreed to participate in the study will be given an informed consent form, a personal information form, and menopause-specific quality of life and menopause symptom assessment scales and asked to fill them out. The women will be interviewed again 15 days later and given the menopause-specific quality of life and menopause symptom assessment scales again and asked to fill them out. In addition, the benefits of the mandala application will be explained to the women in order to eliminate the ethical dilemma, and coloring pencils with mandalas will be given to women who want to do the application. The women's routine care and treatments will continue during the data collection period. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The study included women who met the following conditions:
- Absence of cognitive, hearing, or speech impairments that could interfere with effective communication,
- No physical, psychological, or visual limitations that could hinder participation in mandala coloring activities,
- Literacy in Turkish, including the ability to read, comprehend, and write,
- A confirmed medical diagnosis of menopause,
Key exclusion criteria (5 listed)
- Participants were excluded from the study if they:
- Provided incomplete or inaccurate responses in the data collection forms,
- Were receiving hormone therapy to manage menopausal symptoms,
- Had a neurological disorder that could impair concentration or communication during the mandala activity,
- Had known allergies to paints or similar substances.
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 coloringIntervention Group: The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied. Participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the process, the scales will be re-applied and the follow-up forms will be collected. Their routine treatments will continue. | Other | Intervention Group |
Primary outcome
Menopausal Symptoms Assessment Scale (MSAS) total score
Time frame: Pre-intervention (day 0) and post-intervention (day 15)
Evaluation of the effect of mandala practice on the severity of somatic, psychological and urogenital symptoms in menopausal women. The MSAS consists of 11 items and three subscales. The subscales are labeled "Somatic Complaints," "Psychological Complaints," and "Urogenital Complaints." The scale is answered on a 5-point Likert-type scale, with each item scored as follows: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Extremely severe. The lowest possible score for the entire scale is 0, and the highest is 44. A higher total score indicates an increase in the severity of the complaints and a negative impact on quality of life.
1 secondary outcome
Menopause-Specific Quality of Life Scale (MSQL) total and sub-dimension scores
Time frame: Pre-intervention (day 0) and post-intervention (day 15)
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 Aug 2025.
- Study Rationale and ReferencesLink provided by the sponsor.
- Study Rationale and ReferencesLink provided by the sponsor.
- Study Rationale and ReferencesLink provided by the sponsor.
- Study Rationale and ReferencesLink provided by the sponsor.
- Study Rationale and ReferencesLink provided by the sponsor.
- Study Rationale and ReferencesLink provided by the sponsor.
- Individual participant dataSharing planned: No. It is not planned to share individual participant data collected in this study. This is because participant privacy was not protected and explicit consent for data sharing was not obtained. In addition, due to the sensitive nature of the data and ethical responsibilities, it was not deemed appropriate to share it with third parties.
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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.
Emine Karacan, Asst Prof study chair
Gaziantep Islamic Science and Technology University
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 in people with Menopause Symptom Management and Quality of Life, run by Emine Karacan 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 7 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 Aug 2025. 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 Emine Karacan, Asst Prof (+90 537 214 83 75, emine.karacan@gibtu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal Symptoms Assessment Scale (MSAS) total score (time frame: Pre-intervention (day 0) and post-intervention (day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2025.