NCT07590921

Brief Summary

This study examined the effect of affirmation-based podcast training on fear of childbirth and ruminative thoughts among pregnant women. A randomized controlled design was used, and the study sample consisted of 120 pregnant women (60 in the intervention group and 60 in the control group) who applied to a Family Health Center in Istanbul between February and April 2025. Data were collected through face-to-face interviews using the Pregnant Woman Information Form, the Visual Analog Score, the Fear of Childbirth Scale, and the Positive-Negative Rumination Score. The intervention group listened to affirmation-based podcast recordings for 21 days, while no intervention was applied to the control group. The primary objective was to evaluate the effect of podcast training on fear of childbirth and ruminative thoughts.

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 Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 16, 2026

Last Update Submit

May 12, 2026

Conditions

Fear of ChildbirthRuminationPregnancy

Keywords

AffirmationsPodcastPrenatal EducationCognitive RuminationAcceptance-based Intervention

Outcome Measures

Primary Outcomes (1)

  • Childbirth Fear Scale

    The total ranges from 20 to 100. Higher scores indicate higher levels of fear of childbirth.

    Baseline and 21 days post-intervention.

Secondary Outcomes (1)

  • Positive and Negative Rumination Scale

    Baseline and 21 days post-intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Pregnant women in this group receive a 21-day affirmation-based podcast education program as a supplementary intervention alongside routine care.

Behavioral: Affirmation-based podcast training

Control Group

NO INTERVENTION

Participants receive only standard routine care provided at the health center with no additional intervention.

Interventions

Affirmation-based podcast trainingBEHAVIORAL

Participants listened to the affirmation-based podcast training for 10 minutes each day for 21 days. The podcast recordings were uploaded to the Spotify interface. In addition, they were converted into an HTML link, and a QR code was generated. The podcast was shared with participants via the QR code and the Spotify link. A daily reminder message was sent to encourage listening.

Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant individuals who are biologically female can participate in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • History of abortion or miscarriage Currently undergoing or previously underwent in vitro fertilization (İVF) treatment Presence of chronic diseases (e.g., cardiovascular diseases, diabetes mellitus, hypertension) Presence of psychiatric disorders (e.g., major depression, psychosis) İnability to complete the intervention or follow-up assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Esenyurt Kıraç Family Health Center

Istanbul, Esenyurt, 34510, Turkey (Türkiye)

Location

Kıraç Family Health Center, Esenyurt

Istanbul, Esenyurt, 34510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Study Officials

  • REFİKA GENÇ KOYUCU, DOÇ. DR.

    Istinye University, Republic of Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomization was concealed using a sealed-envelope method until the moment of group assignment. Although allocation was concealed during randomization, the study is open-label as participants are aware of their intervention group assignment following the opening of the envelope.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: It is a randomized controlled, parallel-design intervention study. Affirmation-based podcast training was applied to the intervention group, while no intervention was applied to the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

May 15, 2026

Study Start

February 14, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data will be anonymized in accordance with ethical guidelines and shared only with researchers who request them for scientific research purposes. Requesters must sign a data use agreement. The data will be shared after the completion of the study.

Locations

TU(2)