Fear of ChildbirthNCT07590921
Affirmation-Based Podcast Education for Fear of Childbirth and Rumination in Pregnant Women
A study testing Affirmation-based podcast training in people with Fear of Childbirth and Rumination, run by Istinye University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Rumination, Pregnancy
- What is being tested?
- Affirmation-based podcast training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Feb 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Esenyurt Kıraç Family Health Center
Istanbul, Esenyurt, 34510
Kıraç Family Health Center, Esenyurt
Istanbul, Esenyurt, 34510
About this study
Official title: The Effect of Affirmation-Based Podcast Education on Fear of Childbirth and Ruminative Thoughts in Pregnant Women
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.
- Conditions
- Fear of Childbirth, Rumination, Pregnancy
- Being tested
- Affirmation-based podcast training
- Keywords
- Affirmations, Podcast, Prenatal Education, Cognitive Rumination, Acceptance-based Intervention
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affirmation-based podcast trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pregnant women in this group receive a 21-day affirmation-based podcast education program as a supplementary intervention alongside routine care. Receives: Behavioral: Affirmation-based podcast training |
| Control Group | No intervention | Participants receive only standard routine care provided at the health center with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Fear Scale
The total ranges from 20 to 100. Higher scores indicate higher levels of fear of childbirth.
Measured: Baseline and 21 days post-intervention.
Secondary outcomes (1)
Positive and Negative Rumination Scale
The total ranges from 23 to 115. Higher scores indicate higher levels of rumination.
Measured: Baseline and 21 days post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start14 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REFİKA GENÇ KOYUCU, DOÇ. DR., Study director, Istinye University, Republic of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590921
- Sponsor's protocol ID
- 24-174
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Affirmation-Based Podcast Education on Fear of Childbirth and Ruminative Thoughts in Pregnant Women
- ClinicalTrials.gov ID
- NCT07590921
- Acronym / sponsor ID
- 24-174
- Conditions
- Fear of Childbirth, Rumination, Pregnancy
- Keywords
- Affirmations, Podcast, Prenatal Education, Cognitive Rumination, Acceptance-based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Affirmation-based podcast trainingPregnant women in this group receive a 21-day affirmation-based podcast education program as a supplementary intervention alongside routine care. |
| Control Group | No intervention | –Participants receive only standard routine care provided at the health center with no additional intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affirmation-based podcast trainingParticipants 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. | Behavioural | Experimental Group |
Primary outcome
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.
1 secondary outcome
Positive and Negative Rumination Scale
Time frame: Baseline and 21 days post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REFİKA GENÇ KOYUCU, DOÇ. DR. study director
Istinye University, Republic of Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affirmation-based podcast training in people with Fear of Childbirth and Rumination, run by Istinye University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Fear Scale (time frame: Baseline and 21 days post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.