Mandala Intervention on Mother-Infant Bonding and Parenting Self-Efficacy After Negative Birth Ex… (NCT07461922) | Clinical Trial Compass
CompletedNot Applicable
Mandala Intervention on Mother-Infant Bonding and Parenting Self-Efficacy After Negative Birth Experiences
Turkey (Türkiye)66 participantsStarted 2025-06-26
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mother-Infant Bonding Scale (MIBS)
Timeframe: Immediately after the intervention (Day 1) and post intervention