Effect of Mandala Practice on Menopausal Symptoms and Quality of Life
Phase: NA
Conditions: Menopause Symptom Management, Quality of Life, Menopausal Symptoms
Sponsor: Emine Karacan

Official Title Of The Study 
 
The effect of Mandala application on menopausal symptoms and quality of life 
 
NCT Number 
 
NCT number not received yet 
 
Date of Document 
 
This file was prepared to be sent to the ethics committee on February 13, 2025. A 
request for correction was received from the ethics committee on February 26, 
2025, and ethics committee approval was received on March 3, 2025. 

(The protocol should include the following items and necessary explanations) 
C. Study Protocol 
1. Project Name: The effect of Mandala application on menopausal symptoms and quality of life 
2. Project Rationale: Menopause is the natural cycle of life that develops due to changes in the 
endocrine glands of the female body, mostly in middle age, and the menstrual cycle is permanently 
interrupted as a result of the ovaries losing their activity (Koyuncu et al., 2015; Gönenç, 2019). Many 
symptoms are seen 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 deteriorate their quality 
of life (Gönenç and Koç, 2019). In reducing the menopause symptoms experienced by women, hormone 
replacement therapy, traditional methods (Johonson, et al. 2019), mental or physical practices; 
Applications such as aromatherapy (Abiç and Yılmaz; 2020), hypnosis (Roberts, et al., 2021), 
Biofeedback and relaxation techniques (Huang, et al., 2015) are used. The aim of these applications is 
to relax women, reduce menopause 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 
(Ergül et al., 2021; Çelikbaş, 2022) and is defined as a complementary, safe and accessible activity that 
supports mental health (Çelikbaş, 2022). It has been determined that the mandala method, which is used 
in many areas in the literature, has not been examined how it affects the symptoms and quality of life of 
women in the menopausal period. For this reason, it is thought that this study will make a significant 
contribution to the literature. 
3. Materials and Methods of the Study: 
3.1. Location of the study: This study is planned to be conducted at Private Palmiye Hospital 
Gynecology and Obstetrics Polyclinics. 
3.2. Time of the study: The study is planned to be conducted within 6 months after obtaining the ethics 
committee approval. 
3.3. Universe, sample, research group of the study: The universe of the study will consist of women 
who apply to the gynecology and obstetrics polyclinics of the hospital where the study will be conducted 
and who have been diagnosed with menopause. The sample of the study was calculated using the 
G*Power program by taking as reference the study titled “Association of menopausal symptoms and 
menopausal quality of life with premenstrual syndrome” (Okutucu et al., 2023) (α=0.05, 1-β=0.85, effect 
size d=0.68) and was determined as 39 participants for the experimental and control groups. 
As a result, the study sample will consist of 78 postmenopausal women (39 in the experimental group 
and 39 in the control group) as shown in the CONSORT 2010 flow chart. 

Randomization: The random.org program will be used to assign participants to their groups. Women 
who are “1” in the randomization will be included in the control group, and women who are “2” will be 
included in the intervention group. Women participating in the study will be unaware of the current 
group number and which method will be applied in the group they are assigned to. The study will be 
conducted with two groups, one experimental and one control group. 
Inclusion and exclusion criteria for the study; 
Inclusion Criteria; Women who can communicate, read, understand and write Turkish, have been 
diagnosed with menopause, and do not have any physical or mental disabilities related to performing 
the mandala application will be included in the study. 
Exclusion Criteria; Women who do not fill out the data collection forms completely, women who are 
receiving hormonal treatment to reduce menopausal symptoms, and women with dye allergies will be 
excluded from the study. 
3.4. Type of study: This study is planned as a randomized controlled experimental study. 
3.5. Manpower required for the research: 
Emine Karacan: Analysis of data, writing the introduction 
Emine Bakır: Determination of the topic, literature review, collection of data, writing the discussion 
Emine Karacan: Writing the material/method section, making final checks 
3.6. Research method and data collection tools: 
Data Collection Tools: The data of the study were collected using the Menopause Symptoms 
Assessment Scale, Menopause Specific Quality of Life Scale and Mandala Application Follow-up Form. 
Personal Information Form; The personal information form, which was created by evaluating the 
studies on menopause symptoms, quality of life in women and affecting factors in the literature review, 
consists of 12 questions (Gönenç, 2019; Abiç, 2020). 
Menopause Symptoms Assessment Scale (MSS); MSS was developed by Schneider and his 
colleagues in 1992. The Turkish validity and reliability study was conducted by Gürkan in 2005. MSS 
consists of 11 items and 3 sub-dimensions. The sub-dimensions are called “Somatic Complaints”, 
“Psychological Complaints”, and “Urogenital Complaints”. The scale is answered on a 5-point Likert 
type and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The 
lowest score that can be obtained from the entire scale is 0 and the highest score is 44. An increase in 
the total score obtained from the scale indicates an increase in the severity of the complaints experienced 
and that the quality of life is negatively affected. The Cronbachalpha reliability coefficient of the original 
scale is 0.84. The Cronbachalpha values of the sub-groups are 0.65 for somatic complaints, 0.79 for 

psychological complaints and 0.72 for urogenital complaints. The Cronbachalpha value of MSDS was 
calculated as 0.80 in this study. The chronbachalpha values of the subgroups were found to be 0.66 for 
somatic complaints, 0.75 for psychological complaints, and 0.71 for urogenital complaints.  
Menopause-Specific Quality of Life Scale; was developed by Hilditch et al. in 1996, and its Turkish 
validity and reliability were made by Kharbouch and Şahin in 2005 (Kharbouch and Şahin, 2007). The 
scale consists of four areas: vasomotor, psychosocial, physical, and sexual, contains 29 Likert-type 
expressions, and as the score obtained from the scale increases, the severity of the complaint increases 
and the quality of life decreases. Since the average score is used in the total scale, the lowest score that 
can be obtained from the scale is 0, and the highest score is 6. Each subfield score in the MÖYKÖ is 
ranked from 0 to 6. A score of “0” indicates that no problem is experienced regarding the subject. A 
score of “1” indicates that the problem exists, is experienced but is not disturbing at all, while scores 
between “2-6” indicate the severity and increasing degrees of the existing problem. In the original study, 
the Cronbach alpha value of the sub-dimensions of the scale was found to be 0.73 for the vasomotor 
domain, 0.84 for the psychosocial domain, 0.88 for the physical domain and 0.84 for the sexual domain. 
In this study, the Cronbach alpha value of the total scale was found to be 0.90 and the Cronbach alpha 
value of the sub-dimensions was found to be 0.75 for the vasomotor domain, 0.83 for the psychosocial 
domain, 0.87 for the physical domain and 0.73 for the sexual domain.  
Mandala application monitoring form; The monitoring form is a schedule where the daily mandala 
application time and application duration will be recorded during the two-week period. The schedule to 
be given to the women with the mandala was received in the second interview to be held with the women 
two weeks later (Table 1). 
Table 1. Mandala Application Follow-up Form 
Date 
Application Time 
Mandala Application Time 
Day 1 
 
 
Day 2 
 
 
Day 3 
 
 
Day 4 
 
 
Day 5 
 
 
Day 6 
 
 
Day 7 
 
 
Day 8 
 
 
Day 9 
 
 
Day 10 
 
 
Day 11 
 
 
Day 12 
 
 
Day 13 
 
 
Day 14 
 
 
Day 15 
 
 
 
Intervention tools and equipment and their use: Mandala and 12-piece felt paint are planned to be 
used in the study as intervention tools. Mandala means “circle” or “completion”, and mandala consists 

of circles arranged in sections surrounding a single central point. However, the result that emerges by 
filling in these circles is considered a complete reflection of its creator. Mandala painting session 
duration and session frequency were determined according to the report published by the Korean Art 
Therapy Association in 2013. According to this report; it was reported that the painting time of the 
mandala can vary between 20-30 minutes (Kim 2014). 
3.7. Data Collection: 
The intervention group; women who applied to the polyclinic and diagnosed with menopause will be 
informed about the study and mandala application in face-to-face interviews. Women who accept to 
participate in the study will be given an informed consent form, a personal information form, 
menopause-specific quality of life and menopause symptom assessment scales and will be asked to fill 
them out. After the women fill out the scales, a sample mandala, an empty mandala, crayons (consisting 
of 12 colors: red, orange, yellow, light green, green, sky blue, blue, purple, brown, reddish brown, white 
and black) and a mandala application follow-up form will be distributed. The mandala application will 
be performed by the women for an average of 20-30 minutes every day for 15 days. The women will be 
called every other day to evaluate their ability to perform the mandala application. After 15 days, the 
women will be interviewed again and the mandala application follow-up form will be collected. Finally, 
the menopause-specific quality of life and menopause symptom assessment scales will be given again 
and asked to fill them out. In addition, the routine care and treatments of the women will continue during 
the data collection period. The control group will be informed about the study during face-to-face 
interviews with women who applied to the outpatient clinic and were diagnosed with menopause, and 
the 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 after 15 days and the menopause-
specific quality of life and menopause symptom assessment scales will be given again and asked to fill 
them out. In addition, the benefits of the mandala application will be explained to the women to eliminate 
the ethical dilemma and the women who want to apply the application will be given mandala coloring 
pencils. The routine care and treatments of the women will continue during the data collection period. 
 
3.8. Data analysis: The data will be analyzed with the SPSS 24.0 package program. When evaluating 
the data of the study, frequency distribution (number, percentage) will be given for categorical variables 
and descriptive statistics (mean, standard deviation) for numerical variables, and normality distribution 
will be done with the Shapiro Wilks test. Independent samples t-test will be used to determine whether 
there is a difference between two normally distributed groups, and one-way variance analysis will be 
used to determine whether there is a difference between more than two groups. In addition, Pearson 
correlation analysis will be used to examine the relationship between two numerical variables. P<0.05 
will be accepted as significance. 
 

3.9. Kaynaklar:  
Gönenç, İ., Koç, G. (2019). Menopoz dönemine yönelik uygulanan eğitim programının kadınların 
menopoza yönelik tutumlarına etkisi. SDÜ Sağlık Bilimleri Dergisi, 10(1), 29-33.  
Koyuncu, T., Ünsal, A., Arslantaş D. (2015). Menopoz tutum değerlendirme ölçeği’nin geçerlilik ve 
güvenilirlik çalışması: Eskişehir-Mahmudiye’de, 40-64 yaş grubu kadınlar üzerinde bir çalışma. 
TAF PreventiveMedicineBulletin. 14(6): 448-452.  
Johnson A et al. (2019). ComplementaryandAlternativeMedicineforMenopause. Journal of Evidence-
BasedIntegrativeMedicine,24:1-14.  
Abiç, A., Yılmaz, DV. (2020). Menopoz semptomlarına yoganın etkisi. Geleneksel ve Tamamlayıcı Tıp 
Dergisi, 3(2):217-23.  
Huang AJ et al. (2015). Device-GuidedSlow-PacedRespirationforMenopausal Hot Flushes: A 
RandomizedControlled Trial. ObstetGynecol, 125(5): 1130-8  
Roberts RL., Rhodes, RJ., Elkins, GR. (2021). Effectof hypnosis on anxiety: resultsfrom a 
randomizedcontrolledtrialwithwomen 
in 
postmenopause. 
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ClinPsycholMedSettings. 
28(4):868-881.  
Çelikbaş, Ayça Şolt, and Elif Dağlı. "Theeffect of mandala coloring on pregnancy-relatedanxiety." 
EuropeanJournal of Obstetrics&GynecologyandReproductiveBiology 292 (2024): 251-258.  
Ergül, İ., Ergül, E., Ergül, E. (2021). Mandala ve sanat terapisine tarihsel ve klinik bakış. Türkiye 
Bütüncül Psikoterapi Dergisi, 4(7):36-48.  
Tuygar-Okutucu F, Cimilli-Senocak G, Ceyhun HA, Ozcan H. Association of menopausal symptoms 
and menopausal quality of life with premenstrual syndrome. Malawi Med J. 2023 Jun;35(2):95-
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Schneider HPG, Heinemann LAJ, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale 
(MRS): reliability of scores of menopausal complaints. Climacteric. 2000;3(1):59-64.  
Gürkan, ÖC. (2005).Menopoz semptomları değerlendirme ölçeğinin türkçe formunun güvenirlik ve 
geçerliliği.Hemşirelik Forumu Dergisi.3:30-35.  
Hilditch JR, Lewis J, Peter A, Maris BV, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. (1996). 
A menopause-specific quality of life questionnaire: development and psychometric properties. 
Maturitas, 24, 161-175.  
Kharbouch S. B. ve Şahin, N. H. (2007). Menopozal dönemlerdeki yaşam kalitesinin belirlenmesi. 
Florence Nightingale Hemşirelik Dergisi, 15(59), 82-90.  
Kim, H. K., Kim, K. M., & Nomura, S. (2016). The effect of group art therapy on older Korean adults 
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