NCT07704541

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 13, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

June 13, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

mandala art therapychildbirth fearobstetric waiting room

Outcome Measures

Primary Outcomes (1)

  • Childbirth Fear

    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)

Study Arms (2)

Mandala Art Therapy Group

EXPERIMENTAL

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.

Behavioral: Mandala Art Therapy

Control Group

NO INTERVENTION

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.

Interventions

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.

Mandala Art Therapy Group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hildingsson I, Johansson M, Fenwick J, Haines H, Rubertsson C. Childbirth fear in expectant fathers: findings from a regional Swedish cohort study. Midwifery. 2014 Feb;30(2):242-7. doi: 10.1016/j.midw.2013.01.001. Epub 2013 Feb 27.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Esra GÜNEY, Associate Professor

    İnönü University Faculty of Health Sciences

    STUDY DIRECTOR
  • Melike Tan, midwife

    İnönü University Faculty of Health Sciences

    STUDY DIRECTOR
  • Zeynep Bal, PhD

    Turgut Özal University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ESRA GÜNEY, Associate Professor

CONTACT

Melike Tan, midwife

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Blinding of participants and investigators is not feasible due to the nature of the intervention (mandala art therapy). Participants are aware of the activity they receive, and the intervention provider is also aware of group allocation. Outcome assessment is performed using standardized self-report scales.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to two parallel groups: an intervention group receiving mandala art therapy and a control group receiving no intervention. Outcome assessments will be performed at baseline, prior to the intervention, and repeated immediately following the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master's student

Study Record Dates

First Submitted

June 13, 2026

First Posted

July 15, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

No, individual participant data will not be shared.