Mother-Infant BondingNCT07461922
Mandala Intervention on Mother-Infant Bonding and Parenting Self-Efficacy After Negative Birth Experiences
A study testing Mandala Coloring and Free Coloring in people with Mother-Infant Bonding, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother-Infant Bonding
- What is being tested?
- Mandala Coloring and Free Coloring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2025to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Having no diagnosed psychological disorders or problems
- Voluntarily agreeing to participate in the research
- Having no communication difficulties
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Mother-Infant Bonding
- Being tested
- Mandala Coloring, Free Coloring
- Keywords
- Mandala Coloring, Mother-Infant Bonding, Art-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringOther
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.
Free ColoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mandala Coloring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention (Day 1) and post intervention
Secondary outcomes (2)
Karitane Parenting Confidence Scale (KPSCS)
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.
Measured: Immediately after the intervention (Day 1) and post intervention
State-Trait Anxiety Inventory (STAI)
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.
Measured: Immediately after the intervention (Day 1) and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start26 Jun 2025
- Primary completion28 Nov 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mother-Infant BondingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Şule Bilgiç, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461922
- Sponsor's protocol ID
- 2025-YÖNP-0105
- Status last verified
- Jun 2025
- First submitted
- 29 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality concerns and ethical restrictions specified in the ethics committee approval.
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 AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet. 2025 Apr 14:S0140-6736(25)00672-5. doi: 10.1016/S0140-6736(25)00672-5. Online ahead of print.
PubMed 40245901
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07461922
- Acronym / sponsor ID
- 2025-YÖNP-0105
- Conditions
- Mother-Infant Bonding
- Keywords
- Mandala Coloring, Mother-Infant Bonding, Art-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Free Cloring | Sham comparator | Other: Free ColoringThe 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. |
| Mandala Coloring | Experimental | Other: Mandala ColoringThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala ColoringThe 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 |
| Free ColoringThe 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 Cloring |
Primary outcome
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.
2 secondary outcomes
Karitane Parenting Confidence Scale (KPSCS)
Time frame: Immediately after the intervention (Day 1) and post intervention
State-Trait Anxiety Inventory (STAI)
Time frame: Immediately after the intervention (Day 1) and post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publicationUcar, E. (2013). Wijma Doğum Beklentisi/Deneyimi Ölçeği B Versiyonu Türkçe uyarlaması ve geçerlilik-güvenilirlik çalışması [Yüksek Lisans Tezi, Hacettepe Üniversitesi].
- Results publicationYılmaz, E., & Oskay, Ü. (2021). Karitane Ebeveyn Kendine Güven Ölçeği'nin Türkçe uyarlaması ve psikometrik değerlendirmesi. Psikiyatri Hemşireliği Dergisi, 12(1), 34-42.
- Results publicationKırca, 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.
- Results publicationAkbulak, F., & Can, R. (2023). Mandala boyamanın ruh sağlığı üzerindeki etkisi: Bir sistematik inceleme. Sanat ve Psikoloji Dergisi, 15(2), 102-117.
- Results publicationAmelia, 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.
- Results publication: PubMed 40245901Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet. 2025 Apr 14:S0140-6736(25)00672-5. doi: 10.1016/S0140-6736(25)00672-5. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality concerns and ethical restrictions specified in the ethics committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring and Free Coloring in people with Mother-Infant Bonding, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-Infant Bonding Scale (MIBS) (time frame: Immediately after the intervention (Day 1) and post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461922, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.