Mandala Coloring in Late Pregnancy

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

• Pretest (28 weeks of gestation, before the intervention): Personal Information Form, Depression Anxiety Stress Scale-21 (DASS-21), Women's Health Initiative Insomnia Rating Scale (WHIIRS) and Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A).
• Posttest (after the 8-week intervention, before birth): DASS-21, WHIIRS and W-DEQ A.
• Postpartum: Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ B) and the Postpartum Parameters Form (mode of delivery, duration of labor, birth weight, 1- and 5-minute Apgar scores, gestational age at birth, and maternal/neonatal complications), recorded from patient files and delivery records.

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.