- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704541
Effect of Mandala Art Therapy on Childbirth Fear and Anxiety in Expectant Fathers
July 17, 2026 updated by: Melike TAN ÇELİK, Inonu University
The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study
This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor.
Eligible participants will be randomly allocated to either the intervention or the control group.
Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention.
Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention.
The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among expectant fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor.
Eligible participants will be randomly allocated to either the intervention or the control group using a simple randomization procedure.
Participants assigned to the intervention group will receive a single, individually administered mandala art therapy session lasting approximately 20-25 minutes.
During the session, participants will be encouraged to select their preferred mandala patterns and colors, thereby facilitating individual expression and engagement in the therapeutic process.
Participants in the control group will receive routine care without any additional intervention and will undergo the same assessment procedures as the intervention group.
Data will be collected at two time points: immediately before the intervention (baseline) and immediately after the intervention.
The primary outcome of the study is childbirth fear, while the secondary outcome is state anxiety.
Study Type
Interventional
Enrollment (Estimated)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ESRA GÜNEY, Associate Professor
- Phone Number: +90 5432064063
- Email: esra.guney@inonu.edu.tr
Study Contact Backup
- Name: Melike Tan, midwife
- Phone Number: +90 5452259635
- Email: melike9635@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study
Exclusion Criteria:
- Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandala Art Therapy Group
Participants in this group will receive mandala art therapy.
The intervention consists of a 20-25 minute individual mandala coloring activity conducted in the obstetric waiting area.
Participants will be provided with a mandala coloring book and colored pencils and will freely choose patterns and colors.
|
Participants will engage in a mandala coloring activity lasting approximately 20-25 minutes.
The intervention is designed as a relaxation-based expressive art therapy.
Participants will select mandala patterns and colors freely.
No guidance or psychological counseling is provided during the activity.
|
|
No Intervention: Control Group
Participants in this group will receive no intervention.
They will complete the same pre-test and post-test assessments as the intervention group at the same time points.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth Fear
Time Frame: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
|
Childbirth fear will be assessed using the Fathers' Birth Fear Scale (BDKÖ).
The scale measures fathers' fear related to childbirth process and hospital-related concerns.
Higher scores indicate higher levels of childbirth fear.
Assessments will be performed before and after the mandala art therapy intervention.
|
Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Melike Tan, midwife, İnönü University Faculty of Health Sciences
- Study Director: Esra GÜNEY, Associate Professor, İnönü University Faculty of Health Sciences
- Principal Investigator: Zeynep Bal, PhD, Turgut Özal University Faculty of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
June 13, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 15, 2026
Study Record Updates
Last Update Posted (Actual)
July 20, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No, individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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