- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461922
Mandala Intervention on Mother-Infant Bonding and Parenting Self-Efficacy After Negative Birth Experiences
The Effect of a Mandala-Based Intervention on Mother-Infant Bonding and Parenting Self-Efficacy in Primiparous Women With a Negative Birth Experience: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial evaluates the effects of a mandala-based intervention on mother-infant bonding and parenting self-efficacy in primiparous women (first-time mothers) who experienced a negative birth experience.
Study Design and Population The study was conducted in the obstetrics clinic of a hospital. Power analysis indicated a minimum sample size of 44 participants to achieve 80% power at a 0.05 significance level. To account for potential attrition, the study aimed for 70 participants and was completed with 66 mothers (34 in the Mandala Group and 32 in the Free Coloring Group).
Inclusion Criteria Eligible participants included women who had a vaginal delivery, were within the first seven days postpartum, were primiparous with a singleton pregnancy, and self-reported a negative birth experience confirmed by a score of 37 or above on the Wijma Delivery Expectancy/Experience Questionnaire Version B. Participants were required to have no diagnosed psychological disorders and no communication difficulties.
Randomization and Procedure Participants were randomly assigned to either the Mandala Coloring Group or the Free Coloring Group using random allocation software. Data collection occurred at two time points: before and after the intervention.
Intervention Protocols The intervention was conducted face-to-face in a quiet, supportive environment under researcher supervision, typically when the infant was asleep. Each session lasted approximately 30 minutes.
Mandala Coloring Group: This structured relaxation process included brief information on mandala philosophy, five minutes of "box breathing" relaxation, and guided imagery of a seaside scene. Participants created and colored a "wish mandala" representing personal intentions, accompanied by shamanic drum rhythm music. The session concluded with the creation of a "stress mandala" using spiral drawings to symbolically release stress.
Free Coloring Group: This activity allowed participants to express emotions spontaneously without guidance. Participants began drawing without prior planning, and the resulting images were evaluated as personal reflections rather than artistic products.
Outcome Assessments The primary outcomes include changes in the Mother-Infant Bonding Scale and the Karitane Parenting Confidence Scale. Secondary outcomes include changes in anxiety levels measured by the State-Trait Anxiety Inventory. Ethical approval was obtained prior to the study, and all participants provided written informed consent in accordance with the Declaration of Helsinki.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çanakkale, Turkey (Türkiye)
- Canakkale Onsekiz Mart University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Sham Comparator: Free Cloring
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. |
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. |
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Experimental: Mandala Coloring
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother-Infant Bonding Scale (MIBS)
Time Frame: Immediately after the intervention (Day 1) and post intervention
|
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.
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Immediately after the intervention (Day 1) and post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Karitane Parenting Confidence Scale (KPSCS)
Time Frame: Immediately after the intervention (Day 1) and post intervention
|
The Karitane Parenting Confidence Scale is a 14-item self-report instrument used to assess parental self-confidence in mothers and fathers of infants aged 0-12 months.
Each item is scored on a 4-point scale.
One item is reverse-scored to ensure internal consistency.
Total scores on the scale range from a minimum of 0 to a maximum of 42.
A higher total score indicates a higher level of parental self-confidence, which represents a better outcome.
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Immediately after the intervention (Day 1) and post intervention
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State-Trait Anxiety Inventory (STAI)
Time Frame: Immediately after the intervention (Day 1) and post intervention
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The State-Trait Anxiety Inventory (STAI) is a self-report instrument used to measure both temporary anxiety (State Anxiety) and long-standing anxiety trends (Trait Anxiety).
The scale consists of two parts, each containing 20 items scored on a 4-point Likert scale (1 to 4).
The inventory includes both direct statements (expressing negative emotions) and reversed statements (expressing positive emotions).
Total scores for each part range from a minimum of 20 to a maximum of 80.
A higher total score indicates a higher level of anxiety, which represents a worse outcome.
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Immediately after the intervention (Day 1) and post intervention
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Collaborators and Investigators
Publications and helpful links
General Publications
- Ucar, E. (2013). Wijma Doğum Beklentisi/Deneyimi Ölçeği B Versiyonu Türkçe uyarlaması ve geçerlilik-güvenilirlik çalışması [Yüksek Lisans Tezi, Hacettepe Üniversitesi].
- Yılmaz, E., & Oskay, Ü. (2021). Karitane Ebeveyn Kendine Güven Ölçeği'nin Türkçe uyarlaması ve psikometrik değerlendirmesi. Psikiyatri Hemşireliği Dergisi, 12(1), 34-42.
- 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.
- Akbulak, F., & Can, R. (2023). Mandala boyamanın ruh sağlığı üzerindeki etkisi: Bir sistematik inceleme. Sanat ve Psikoloji Dergisi, 15(2), 102-117.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-YÖNP-0105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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