Effect of Mandala Practice on Menopausal Symptoms and Quality of Life

August 27, 2025 updated by: Emine Karacan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • İskenderun
      • Hatay, İskenderun, Turkey (Türkiye)
        • Private Palmiye Hospital, Gynecology and Obstetrics Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Emine Karacan, Asst Prof
        • Sub-Investigator:
          • Emine Karacan2, Asst Prof
        • Principal Investigator:
          • Emine Bakır, Spec Nurse

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The study included women who met the following conditions:
  2. Absence of cognitive, hearing, or speech impairments that could interfere with effective communication,
  3. No physical, psychological, or visual limitations that could hinder participation in mandala coloring activities,
  4. Literacy in Turkish, including the ability to read, comprehend, and write,
  5. A confirmed medical diagnosis of menopause,
  6. Not undergoing any form of psychotherapy or alternative treatment throughout the study period,
  7. Voluntary participation with signed informed consent.

Exclusion Criteria:

  1. Participants were excluded from the study if they:
  2. Provided incomplete or inaccurate responses in the data collection forms,
  3. Were receiving hormone therapy to manage menopausal symptoms,
  4. Had a neurological disorder that could impair concentration or communication during the mandala activity,
  5. Had known allergies to paints or similar substances.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
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.
Other: Mandala coloring

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.
No Intervention: The control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention (day 0) and post-intervention (day 15)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Menopause-Specific Quality of Life Scale (MSQL) total and sub-dimension scores
Time Frame: Pre-intervention (day 0) and post-intervention (day 15)
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.
Pre-intervention (day 0) and post-intervention (day 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emine Karacan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Emine Karacan, Asst Prof, Gaziantep Islamic Science and Technology University

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol No:2025/523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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