Mandala-Based Intervention in Pregnancy: A Randomized Controlled Trial

NCT07855289 | Not Yet Recruiting

• 1 other identifier: BARU-SBF-MANDALA-2026
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether a mandala-based coloring program affects pregnant women's perceptions of traumatic childbirth, behavioral emotion regulation, and psychological resilience. Pregnant women aged 18 to 49 years will be randomly assigned to a mandala intervention group or a control group. Participants in the intervention group will attend eight 45-minute sessions over four weeks (two sessions per week). Sessions will include brief preparation and breathing exercises, mandala coloring, and a short discussion. The control group will receive no study intervention. Participants in both groups will complete questionnaires before the intervention, immediately afterward, and at one-month and three-month follow-up assessments. Researchers will compare changes in the groups' questionnaire scores.

Conditions

Perception of Traumatic Childbirth; Psychological Resilience; Behavioral Emotion Regulation

Keywords

Pregnancy; Mandala Coloring; Antenatal Care; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Perception of Traumatic Childbirth Scale score

  The 13-item Perception of Traumatic Childbirth Scale measures anticipated traumatic childbirth perception. Total scores range from 0 to 130; higher scores indicate a stronger perception of traumatic childbirth. Change from baseline will be compared between groups.

  Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention

Secondary Outcomes (2)

• Change in Behavioral Emotion Regulation Questionnaire subscale scores

  Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention

• Change in Brief Resilience Scale score

  Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly.

Behavioral: Mandala-Based

control

NO INTERVENTION

Participants will receive no study intervention. Outcome assessments will be performed at the same time points as in the intervention group.

Interventions

Mandala-Based BEHAVIORAL

Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly.

Experimental group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18 and 49,
• Being in the 1st, 2nd, or 3rd trimester,
• Volunteering to participate in the study,
• Completing the forms in full,

You may not qualify if:

• Having a diagnosis of a high-risk pregnancy,
• Not wishing to continue with the study,
• Experiencing communication difficulties (not knowing Turkish, or having hearing, speech, or comprehension impairments),

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Bartın University

Bartın, Bartın, 74100, Turkey (Türkiye)

Location

Study Officials

• Güleser ADA, PhD

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Güleser ADA, PhD

CONTACT

538-450-85-47; gada@bartin.edu.tr

Ebru CİRBAN EKREM, PhD

CONTACT

534-392-16-20; ecirban@bartin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: experimental and control group

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)