NCT07775963

Brief Summary

This randomized controlled trial evaluates the effects of mandala coloring and music listening on fear of childbirth among pregnant women. Participants are randomly assigned to one of three groups: a mandala coloring group, a music listening group, or a control group. The interventions are non-pharmacological, art-based approaches intended to support relaxation and reduce fear related to childbirth. Fear of childbirth is assessed before and after the interventions using validated measurement tools. The study aims to determine whether mandala coloring and music listening are effective in reducing fear of childbirth and to compare the effectiveness of these two approaches with routine care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Fear of ChildbirthTokophobiaPregnancyPregnant WomenMandala ColoringMusic ListeningArt-Based InterventionNon-Pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire Version A

    Fear of childbirth was assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A. The questionnaire consists of 33 items and provides a total score ranging from 0 to 165. Higher scores indicate a higher level of fear of childbirth. The questionnaire was administered before and after the intervention to evaluate changes in fear of childbirth among the mandala coloring, music listening, and control groups.

    Baseline and immediately after the intervention

Secondary Outcomes (1)

  • Pain Level Assessed Using the Visual Analog Scale

    Baseline and immediately after the intervention

Study Arms (3)

Mandala Coloring Group

EXPERIMENTAL

Participants assigned to this group received the mandala coloring intervention in addition to routine care. The intervention was designed to reduce fear of childbirth through a structured art-based activity.

Behavioral: Mandala Coloring

Music Listening Group

EXPERIMENTAL

Participants assigned to this group received the music listening intervention in addition to routine care. The intervention was designed to promote relaxation and reduce fear of childbirth.

Behavioral: Music Listening

Control Group

NO INTERVENTION

Participants assigned to the control group received routine care and did not receive the mandala coloring or music listening intervention.

Interventions

Participants in the mandala coloring group received a structured mandala coloring intervention in addition to routine care. The intervention involved coloring predetermined mandala patterns and was implemented as a non-pharmacological, art-based approach to reduce fear of childbirth.

Also known as: Mandala Art Intervention
Mandala Coloring Group
Music ListeningBEHAVIORAL

Participants in the music listening group received a structured music listening intervention in addition to routine care. The intervention involved listening to music and was implemented as a non-pharmacological approach to promote relaxation and reduce fear of childbirth.

Also known as: Music Intervention
Music Listening Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-35 years
  • Primiparous pregnant women
  • Pregnant women who met the gestational week criteria specified in the study protocol
  • Pregnant women with fear of childbirth
  • Ability to communicate in Turkish
  • Voluntary agreement to participate in the study

You may not qualify if:

  • Presence of a high-risk pregnancy or pregnancy-related complication
  • Presence of a diagnosed psychiatric disorder or use of psychiatric medication
  • Presence of a condition that could prevent participation in the interventions
  • Participation in another intervention aimed at reducing fear of childbirth
  • Withdrawal from the study or failure to complete the intervention and outcome assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was blinded to the participants' group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to three parallel groups: mandala coloring, music listening, and control. The effects of the interventions on fear of childbirth were evaluated and compared between the groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 20, 2026

Study Start

November 15, 2025

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations