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NCT07764484
COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH.
Conditions: Fear of Childbirth, Mandala Coloring
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Ataturk University
Summary
This randomized controlled trial aims to evaluate whether a mandala coloring activity during labor can reduce birth anxiety and fear of childbirth among primiparous pregnant women experiencing their first birth. The study will be conducted among eligible primiparous women admitted to the delivery unit at Şanlıurfa Training and Research Hospital during active labor.
A total of 140 primiparous pregnant women will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive standard labor care in addition to a structured mandala coloring activity beginning when cervical dilation is between 5 and 8 cm. Participants will be provided with standardized mandala drawings and coloring pencils and will be encouraged to color during contractions as tolerated until birth. Women in the control group will receive routine labor and obstetric care without an additional art-based or distraction intervention. Routine maternal and fetal monitoring will continue in both groups throughout labor.
Birth-related anxiety and fear will be assessed before the intervention during the active phase of labor and after birth. The study will use validated measures to evaluate fear of childbirth and birth-related anxiety. The study will also record relevant obstetric outcomes, including mode of delivery, analgesia use, and duration of labor.
The study seeks to answer whether adding a simple, low-cost, non-pharmacological mandala coloring activity to routine labor care can reduce birth anxiety and fear of childbirth in primiparous women. The findings may provide evidence for the use of accessible, non-pharmacological supportive interventions as part of midwifery care during labor.
Eligibility Criteria
Inclusion Criteria:
Primiparous pregnant women Age between 18-45 years Single pregnancy Full-term pregnancy (≥37 weeks) Planned vaginal delivery Ability to communicate and give informed voluntary consent Absence of diagnosed psychiatric disorder.
Exclusion Criteria:
High-risk pregnancy status (e.g., preeclampsia) Gestational diabetes requiring insulin Indication for emergency cesarean section Hearing or cognitive impairment Use of anxiolytic or psychiatric medications Refusal to participate in the study Intranatal complications preventing participation in mandala painting intervention
Source: ClinicalTrials.gov (NCT07764484). StuddyBuddy aggregates publicly available trial information.