Effect of Mandala Practice on Menopausal Symptoms and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorEmine Karacan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Mandala coloring
Other interventionIntervention 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: The control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
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.
Time frame
Pre-intervention (day 0) and post-intervention (day 15)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emine Karacan
Lead sponsor
Gaziantep Islam Science and Technology University
Sponsor institution
Source ClinicalTrials.gov
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