- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590921
Affirmation-Based Podcast Education for Fear of Childbirth and Rumination in Pregnant Women
The Effect of Affirmation-Based Podcast Education on Fear of Childbirth and Ruminative Thoughts in Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Esenyurt
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Istanbul, Esenyurt, Turkey (Türkiye), 34510
- Esenyurt Kıraç Family Health Center
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Istanbul, Esenyurt, Turkey (Türkiye), 34510
- Kıraç Family Health Center, Esenyurt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
İnclusion Criteria:
Pregnant women Aged 18-45 years Turkish citizens Having a fear of childbirth score ≥5 on the Visual Analog Scale (VAS) Having access to a device to listen to the podcast and download audio files Willing to participate in the study
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Pregnant women in this group receive a 21-day affirmation-based podcast education program as a supplementary intervention alongside routine care.
|
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.
|
|
No Intervention: Control Group
Participants receive only standard routine care provided at the health center with no additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth Fear Scale
Time Frame: Baseline and 21 days post-intervention.
|
The total ranges from 20 to 100.
Higher scores indicate higher levels of fear of childbirth.
|
Baseline and 21 days post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Rumination Scale
Time Frame: Baseline and 21 days post-intervention.
|
The total ranges from 23 to 115.
Higher scores indicate higher levels of rumination.
|
Baseline and 21 days post-intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: REFİKA GENÇ KOYUCU, DOÇ. DR., Istinye University, Republic of Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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