NCT07461922

Brief Summary

The purpose of this randomized controlled trial is to evaluate the impact of a mandala-based art intervention on mother-infant bonding and parenting self-efficacy among primiparous women (first-time mothers) who have had a negative birth experience. The study focuses on how structured creative activities can support emotional recovery and maternal confidence in the early postpartum period. A total of 66 participants were randomly assigned to either a Mandala Coloring Group or a Free Coloring Group. The intervention group participated in a structured session involving guided breathing, imagery, and symbolic mandala drawing designed for stress reduction and emotional expression. The control group engaged in a non-guided, free coloring activity. Data were collected using standardized tools, including the Mother-Infant Bonding Scale, the Karitane Parenting Confidence Scale, and the State-Trait Anxiety Inventory. The primary goal is to determine if the mandala-based intervention leads to significant improvements in the bond between mother and infant and increases the mother's confidence in her parenting abilities. Secondary outcomes include changes in anxiety levels following the intervention. All procedures were conducted in a supportive environment under researcher supervision to ensure participant safety and data integrity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

December 29, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Mandala ColoringMother-Infant BondingArt-Based Intervention

Outcome Measures

Primary Outcomes (1)

  • Mother-Infant Bonding Scale (MIBS)

    The Mother-Infant Bonding Scale (MIBS) is an 8-item self-report instrument used to evaluate a mother's feelings toward her infant during the early postpartum period. Each item is scored on a 4-point Likert scale (0 to 3). Total scores range from a minimum of 0 to a maximum of 24. The scale includes five reverse-scored items reflecting negative emotions (e.g., anger, disappointment). A higher total score indicates a higher level of bonding difficulties or problematic attachment, which represents a worse outcome. A score of 13 or higher is used as a threshold to predict problematic bonding.

    Immediately after the intervention (Day 1) and post intervention

Secondary Outcomes (2)

  • Karitane Parenting Confidence Scale (KPSCS)

    Immediately after the intervention (Day 1) and post intervention

  • State-Trait Anxiety Inventory (STAI)

    Immediately after the intervention (Day 1) and post intervention

Study Arms (2)

Free Cloring

SHAM COMPARATOR

The free painting activity aims to allow the mother to freely express her feelings without any guidance. Initiation: The participant began drawing without any plan. Creative Flow: The drawings reflected the participant's current mood and emotional state. Exploration and Expression: Inner exploration was achieved through the images and themes that emerged during the process. Completion: Upon completion of the work, the participant evaluated the resulting picture as a personal reflection. This activity was evaluated solely for the purpose of emotional expression, not based on artistic skill.

Other: Free Coloring

Mandala Coloring

EXPERIMENTAL

The mandala practice was carried out as a structured relaxation and expression process with the following steps (Sarı Öztürk et al., 2022): Information: The participant was given brief information about the philosophy of mandalas. Breathing Exercise: Relaxation was practiced for approximately 5 minutes using the "square breath" technique. Guided Visualization: The participant was asked to imagine a scene by the sea and clear their mind. Wish Mandala: The participant was asked to draw and color a mandala representing their own feelings and wishes. It was suggested that the mandala be named and hung in their room if desired. Visualization and Music: The guided visualization process was supported by the rhythm of a shamanic drum in the background. Stress Mandala: The participant released their stress with drawings spiraling outwards from the center, and if desired, completed this work symbolically by tearing it or releasing it into water.

Other: Mandala Coloring

Interventions

The mandala practice was carried out as a structured relaxation and expression process with the following steps (Sarı Öztürk et al., 2022): Information: The participant was given brief information about the philosophy of mandalas. Breathing Exercise: Relaxation was practiced for approximately 5 minutes using the "square breath" technique. Guided Visualization: The participant was asked to imagine a scene by the sea and clear their mind. Wish Mandala: The participant was asked to draw and color a mandala representing their own feelings and wishes. It was suggested that the mandala be named and hung in their room if desired. Visualization and Music: The guided visualization process was supported by the rhythm of a shamanic drum in the background. Stress Mandala: The participant released their stress with drawings spiraling outwards from the center, and if desired, completed this work symbolically by tearing it or releasing it into water.

Mandala Coloring

The free painting activity aims to allow the mother to freely express her feelings without any guidance. Initiation: The participant began drawing without any plan. Creative Flow: The drawings reflected the participant's current mood and emotional state. Exploration and Expression: Inner exploration was achieved through the images and themes that emerged during the process. Completion: Upon completion of the work, the participant evaluated the resulting picture as a personal reflection. This activity was evaluated solely for the purpose of emotional expression, not based on artistic skill.

Free Cloring

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum mother
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having had a vaginal delivery
  • Scoring 37 or above on the Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ-B)
  • Being within the first seven days postpartum
  • Being primiparous (first-time mother) with a singleton pregnancy
  • Self-reporting a negative or adverse birth experience
  • The infant being rooming-in with the mother
  • Having no diagnosed psychological disorders or problems
  • Voluntarily agreeing to participate in the research
  • Having no communication difficulties

You may not qualify if:

  • Having a diagnosed psychiatric disorder or currently receiving psychiatric treatment
  • Use of psychotropic medication during the postpartum period
  • Experiencing severe obstetric complications (e.g., postpartum hemorrhage, eclampsia, emergency hysterectomy)
  • Neonatal complications requiring admission to the neonatal intensive care unit (NICU)
  • Having a multiple pregnancy (twins, triplets, etc.) or a cesarean delivery
  • Severe communication difficulties or inability to understand study procedures
  • Participation in another psychosocial or art-based intervention during the study period
  • Withdrawal of consent at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Turkey (Türkiye)

Location

Related Publications (6)

  • Ucar, E. (2013). Wijma Doğum Beklentisi/Deneyimi Ölçeği B Versiyonu Türkçe uyarlaması ve geçerlilik-güvenilirlik çalışması [Yüksek Lisans Tezi, Hacettepe Üniversitesi].

    RESULT
  • Yılmaz, E., & Oskay, Ü. (2021). Karitane Ebeveyn Kendine Güven Ölçeği'nin Türkçe uyarlaması ve psikometrik değerlendirmesi. Psikiyatri Hemşireliği Dergisi, 12(1), 34-42.

    RESULT
  • Kırca, Ş., Dağlı, H., et al. (2024). Mandala art intervention as a therapy for anxiety in postpartum women: A randomized controlled trial. Women's Mental Health Journal, 18(2), 79-85.

    RESULT
  • Akbulak, F., & Can, R. (2023). Mandala boyamanın ruh sağlığı üzerindeki etkisi: Bir sistematik inceleme. Sanat ve Psikoloji Dergisi, 15(2), 102-117.

    RESULT
  • Amelia, S., Jones, T., & Smith, R. (2020). Art therapy through mandalas: Reducing anxiety and enhancing emotional well-being. Journal of Art Therapy, 26(1), 35-42.

    RESULT
  • Hopewell, S., Chan, A. W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., ... & Boutron, I. (2025). CONSORT 2025 statement: updated guideline for reporting randomised trials. The Lancet, 405(10489), 1633-1640.

    RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This interventional study was designed as a randomized, parallel-group controlled trial. Eligible primiparous postpartum women with a negative birth experience were randomly assigned to one of two parallel arms: a mandala-based intervention group or a free coloring control group. Each participant received only the intervention allocated to her group, and no crossover between groups occurred. Both study arms were conducted concurrently. Outcome measures were assessed at baseline before the intervention and immediately after completion of the single-session intervention. The parallel-group design enabled direct comparison between the intervention and control groups while minimizing contamination and supporting internal validity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 29, 2025

First Posted

March 10, 2026

Study Start

June 26, 2025

Primary Completion

November 28, 2025

Study Completion

December 29, 2025

Last Updated

March 10, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to confidentiality concerns and ethical restrictions specified in the ethics committee approval.

Locations