COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH.

NCT07764484 | Not Yet Recruiting DMC

• 1 other identifier: MANDALA-RCT-2026
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fear of Childbirth; Mandala Coloring

Keywords

CHILDBIRTH FEAR; BIRTH ANXIETY; MANDALA COLORING; PRIMIPAROUS WOMEN; MATERNAL MENTAL HEALTH; NON-PHARMACOLOGICAL INTERVENTION

Outcome Measures

Primary Outcomes (1)

• Birth Anxiety

  Change from baseline in maternal birth anxiety score measured using the Oxford Birth Anxiety Scale (OAS) during labor. Birth anxiety will be assessed immediately before the intervention (baseline) and immediately after the intervention. The outcome will be reported as the change in total OAS score from baseline to immediately after the intervention.

  During labor: baseline before the intervention and immediately after the intervention.

Study Arms (2)

Participant Group/Arm - Mandala

EXPERIMENTAL

Participants will receive a standardized mandala coloring activity in addition to routine labor and obstetric care. The activity will begin during the active phase of labor at 5-8 cm cervical dilation. Participants will be provided with standardized A4-size mandala drawings and 24 colored pencils and will color during contractions as tolerated. The activity will continue until birth unless discontinued due to participant preference or clinical necessity. Routine maternal and fetal monitoring will continue throughout the intervention.

Behavioral: Mandala Coloring Activity During Labor

Control Group

NO INTERVENTION

Participants will receive routine labor and obstetric care without the mandala coloring activity. Routine maternal and fetal monitoring and other clinically indicated care will continue throughout labor.

Interventions

Mandala Coloring Activity During Labor BEHAVIORAL

Participants will engage in a standardized mandala coloring activity during the active phase of labor in addition to routine labor and obstetric care. The activity will begin at 5-8 cm cervical dilation and will continue until birth as tolerated. Participants will use standardized A4-size mandala drawings and 24 colored pencils.

Participant Group/Arm - Mandala

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Central Study Contacts

Neslihan ATLI

CONTACT

+905456330214; neslihanatli96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Participant)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: expert midwife

Model Details: This study is a randomized controlled trial. Participants will be allocated to either the intervention group or the control group. The intervention group will receive mandala coloring activity during labor, while the control group will receive standard routine care. Outcomes will be compared between groups.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share