An interventional study of Mandala Coloring Group in Pregnancy, Anxiety and Depression, sponsored by Fidan Balkaya. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Fidan Balkaya · Not applicable, Interventional, and Supportive care
Anxiety, depression and poor sleep are common in the last months of pregnancy and often occur together. Medication options during pregnancy are limited, so simple, safe non-drug methods are needed. Mandala coloring is an art therapy technique in which a person colors circular patterns; it helps focus attention on the present moment and may have a calming effect.
This randomized controlled trial will examine whether mandala coloring during the third trimester reduces depression, anxiety and stress, improves sleep, and reduces fear of childbirth. It will also look at birth outcomes and the childbirth experience. Pregnant women at 28 weeks of gestation who attend the obstetrics outpatient clinics of Malatya Training and Research Hospital will be randomly assigned to a mandala coloring group or a control group. Women in the mandala group will color two mandalas a week at home for 8 weeks (16 mandalas in total, about 20-30 minutes per session). Women in the control group will receive routine antenatal care only and will be offered the mandala materials after the study ends.
Background Pregnancy involves physiological, psychological, hormonal and social changes. Pregnancy-related anxiety affects about 15-23% of pregnant women, and the prevalence of antenatal depression ranges from 15% to 65%, becoming more marked in the third trimester. Poor sleep quality affects 29-76% of pregnant women and reaches about 60% in the third trimester. Sleep problems, anxiety and depression are closely linked and reinforce one another. These problems are associated with adverse maternal and neonatal outcomes, including postpartum mental health problems, low birth weight, preterm birth, preeclampsia, gestational diabetes and cesarean delivery. Because pharmacological treatment is used cautiously in pregnancy, non-pharmacological approaches are important. Mandala coloring has reduced anxiety and depressive symptoms in various populations and has reduced anxiety and fear of childbirth in pregnant women. However, most studies have examined a single outcome over a short follow-up period, and few have assessed anxiety, depression and sleep together while following women until birth.
Objective To evaluate the effect of mandala coloring in the third trimester on depression, anxiety, stress, insomnia, fear of childbirth, childbirth experience and birth outcomes.
Design Two-arm, parallel-group, randomized controlled trial.
Setting and period Obstetrics and Gynecology Outpatient Clinics of Malatya Training and Research Hospital, Malatya, Türkiye; November 2027 - February 2028.
Participants Pregnant women aged 18 years or older at 28 weeks of gestation with a singleton, low-risk pregnancy who can understand, speak, read and write Turkish, have no physical limitation that prevents coloring, and agree to participate voluntarily.
Randomization and allocation concealment Participants will be randomized 1:1 to the intervention or control group using a computer-generated block randomization list with a block size of 4. The list will be prepared by a researcher independent of the study, and allocation will be concealed using sequentially numbered, opaque, sealed envelopes.
Intervention group Participants will receive a standard verbal and written briefing on the purpose, duration, session frequency and materials of the intervention. Each participant will receive a set of 7-color felt-tip pens and 16 ready-made mandala templates of her choice. She will color two mandalas a week for 8 weeks (16 sessions in total, about 20-30 minutes each) at home, at a time convenient for her, in a calm and quiet setting. To monitor adherence, participants will send a message to the researcher before each session and a photograph of the completed mandala afterwards. Regular reminder messages will be sent throughout the intervention.
Control group Participants will continue their routine antenatal care and will receive no intervention. Participants found to use any pharmacological or non-pharmacological method for the study outcomes during the study period will be excluded. After the study is completed, mandala coloring information and materials will be offered to the control group.
Outcome measures and time points
Data will be collected by the researcher through face-to-face interviews.
Sample size G*Power 3.1 power analysis (one-tailed, α = 0.05, power = 0.95, effect size d = 0.50) indicated 88 participants per group. Allowing for 5% attrition, 93 participants per group (186 in total) will be recruited.
Statistical analysis Data will be analyzed with SPSS 22.0. Descriptive statistics (number, percentage, mean, standard deviation), the chi-square test, the independent samples t-test, the paired samples t-test or repeated measures analysis of variance, and Cronbach's alpha will be used.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 186 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Fidan Balkaya is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presenting to the Obstetrics and Gynecology Outpatient Clinics of Malatya Training and Research Hospital
Exclusion Criteria:
Withdrawal Criteria:
Before the study begins, participants in the experimental group will receive a standard briefing on the mandala coloring intervention from the researcher. In this briefing, participants will be given verbal and written information on the purpose and duration of the intervention, the frequency of sessions and the materials to be used. The intervention will be continued for a total of 8 weeks, with 2 sessions per week. During this period, participants will color 2 mandalas each week, 16 mandalas in total. Each session is planned to last approximately 20-30 minutes.
Behavioral: Mandala Coloring Group
Participants continue their routine antenatal care and receive no intervention during the study. After the study is completed, mandala coloring information and materials will be offered to this group.
Participants color two ready-made mandala templates per week for 8 weeks (16 sessions in total, approximately 20-30 minutes each) at home, at a time convenient for them, in a calm and quiet setting. Each participant receives a set of 7-color felt-tip pens and 16 mandala templates of her choice, together with a standard verbal and written briefing on the purpose, duration, session frequency and materials of the intervention. Adherence is monitored through a message sent to the researcher before each session and a photograph of the completed mandala sent afterwards; regular reminder messages are sent throughout the intervention.
Change in Depression Score (DASS-21 Depression Subscale)
Depression will be assessed with the depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items rated on a 4-point Likert scale (0-3); the subscale score is multiplied by two, giving a range of 0 to 42. Higher scores indicate more severe depression.
Time frame: aseline (28 weeks of gestation) and after the 8-week intervention (36 weeks of gestation)
Change in Anxiety Score (DASS-21 Anxiety Subscale)
Anxiety will be assessed with the anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items rated on a 4-point Likert scale (0-3); the subscale score is multiplied by two, giving a range of 0 to 42. Higher scores indicate more severe anxiety.
Time frame: Baseline (28 weeks of gestation) and after the 8-week intervention (36 weeks of gestation)
Change in Stress Score (DASS-21 Stress Subscale)
Stress will be assessed with the stress subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items rated on a 4-point Likert scale (0-3); the subscale score is multiplied by two, giving a range of 0 to 42. Higher scores indicate more severe stress.
Time frame: Baseline (28 weeks of gestation) and after the 8-week intervention (36 weeks of gestation)
Change in Insomnia Score (Women's Health Initiative Insomnia Rating Scale)
Insomnia symptoms will be assessed with the Women's Health Initiative Insomnia Rating Scale (WHIIRS). The scale consists of 5 items rated on a 5-point Likert scale (0-4), giving a total score range of 0 to 20. Higher scores indicate more severe insomnia symptoms.
Time frame: Baseline (28 weeks of gestation) and after the 8-week intervention (36 weeks of gestation)
Plan to share: No — Individual participant data will not be shared. Participants were not asked to consent to the sharing of their data with third parties, and the ethics committee approval covers the use of the data by the research team only. To protect the confidentiality of participants, who are pregnant women recruited from a single hospital, the data will be stored securely by the research team and used only for the purposes of this study. Aggregate results will be reported in peer-reviewed publications.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 1 month later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 1 month is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fidan Balkaya