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NCT Number: NCT07149285

Effect of Mandala Practice on Menopausal Symptoms and Quality of Life

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.

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Key information

Conditions

Menopause Symptom Management Menopausal Symptoms Quality of Life

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Private Palmiye Hospital, Gynecology and Obstetrics Clinic

Hatay, İskenderun, Turkey (Türkiye)

Location contact

Emine Bakır, Spec Nurse

PRINCIPAL_INVESTIGATOR

Emine Karacan, Asst Prof

CONTACT

[email protected]

+90 537 214 83 75

Emine Karacan, Asst Prof

CONTACT

[email protected]

+90 530 035 04 14

Emine Karacan, Asst Prof

SUB_INVESTIGATOR

Emine Karacan2, Asst Prof

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mandala coloring

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emine Karacan, Asst Prof

CONTACT

[email protected]

+90 537 214 83 75

Emine Karacan, Asst Prof

CONTACT

[email protected]

+90 5300350414

Sponsors and collaborators

Lead sponsor

Emine Karacan

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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