Postnatal CareNCT06740682
The Effect of Potcost Stories on Childbirth Fear,
A study testing Podcast olumlu doğum hikayeler in people with Postnatal Care, run by Burdur Mehmet Akif Ersoy University.
Trial summary
Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Postnatal Care
- What is being tested?
- Podcast olumlu doğum hikayeler
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Those who have completed at least primary school education
- Those who can speak, understand and write Turkish
- Those between the ages of 18-35
- Those who have spontaneous pregnancy
- Those who volunteer to participate in the study
- Those who are in the 24th week of pregnancy according to their last menstrual period (LMT) or ultrasound (USG) records
Show all 9Show fewer
- Those who have no risk factors
- Those who have a phone number that can be used for educational interviews
- Those who attend a pregnancy school
Who cannot join
- Those who have fear of childbirth
- Those who have chronic and/or psychiatric health problems
- Those who did not attend at least three sessions of the education program
- Those who were at risk during the pregnancy at any stage of the study
- Those who could not be interviewed within the first 24 hours after birth were excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Potcost Stories on Childbirth Fear, Pain and Delivery Method
Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Fear of birth is affected by people's past traumatic birth experiences, lack of information, and the transfer of birth experiences experienced by individuals . Birth stories are one of the most accessible and frequently used tools for women to learn about birth. These stories are seen to affect women's fears of birth and their birth preferences .This study will evaluate the impact of Potcost Stories on childbirth-related fear, pain, experiences and mode of delivery.
Read the detailed description
Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Fear of birth is affected by people's past traumatic birth experiences, lack of information, and the transfer of birth experiences experienced by individuals . Birth stories are one of the most accessible and frequently used tools for women to learn about birth. These stories are seen to affect women's fears of birth and their birth preferences .The World Health Organization (WHO) has emphasized the importance of education given during pregnancy in reducing a positive birth experience and fear of birth. . Advances in technology have made podcasts, videos, and mobile phone applications (apps) widely used in training. As a result of these trainings, behavioral changes are observed in people. It has been reported that being supported by midwives during pregnancy and encouraging birth as a positive experience reduces the fear of birth . Therefore, sharing positive birth stories in pregnancy schools and antenatal care is of great importance. However, it is thought that using podcast stories and sharing women's positive birth experiences together will reduce fear during birth and increase vaginal birth. Therefore, in this study, a podcast of stories that pregnant women can listen to again whenever they want, including positive birth experiences, was prepared. This study aimed to determine the effects of potcost stories on fear, pain, satisfaction and birth outcomes related to birth. We aim for the findings and results of the study to contribute to the midwifery and nursing care literature.
This study will evaluate the effects of Potcost Stories on fear, pain, experiences and delivery type related to birth.
- Conditions
- Postnatal Care
- Being tested
- Podcast olumlu doğum hikayeler
- Keywords
- Potcost Stories, fear, pain, experiences, birth
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcast olumlu doğum hikayelerBehavioural
ositive birth stories were listened to by women who gave birth in the hospital included in the study and created with their permission. The podcast recording was done in a single session. These positive birth stories were expertly reviewed by 3 obstetricians and 3 academics. Each podcast content is 10 to 20 minutes (Cai et al., 2023). A WhatsApp reminder msg will be sent so that the stories are not forgotten.
In addition, the pregnant woman will be contacted by phone and trained to listen (Cai et al., 2023).
Participants will be allowed to listen to the podcasts as much as they want (Cai et al., 2023). After listening to each story, their feedback will be received and the participants' doubts will be clarified. (Cai et al., 2023; Çankaya and Şimşek, 2021; Mousavi et al., 2022).
Based on multimedia principles, podcast positive birth experiences will be prepared (Clark and Mayer, 2023). Week 24, Week 30-32, Week 36-38 First story
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Potcost Stories | Active comparator | Not described Receives: Behavioral: Podcast olumlu doğum hikayeler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Birth Expectation/Experience Scale (W-DEQ) Version A
The Wijma Birth Expectation/Experience Scale Version A (W-DEQ A), developed by K. Wijma et al. in Sweden in 1998, was adapted to Turkish by Körükçü et al. in 2012. The W-DEQ consists of 33 items and is a six-point Likert-type scale.
The item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
The cut-off value is 85 points, and a score of 85 and above is expressed as clinical fear. A high total scale score means that the degree of fear experienced is also high.
- W-DEQ score ? 37 is mild,
- W-DEQ score = 38-65 is moderate,
- W-DEQ score = 66-84 is severe,
- W-DEQ score ? 85 indicates clinical fear. Questions 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 in the scale are negatively loaded and are calculated by reversing in order to ensure compliance in the measurement. The Cronbach a
Measured: 1 MOUNT
VASA Pain
The numerical pain rating scale (NAS) is used to assess pain intensity. In the numerical rating scale, pain is rated between 0 (absence of pain) and 10 (unbearable pain) (Price et al., 1983)
Measured: 1 HOUR
Birth Experience Questionnaire (CEQ)
The Birth Experience Questionnaire (CEQ), developed by Dencker et al. in 2010, was adapted to Turkish by Mamuk et al. in 2019. The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. It consists of the Birth process with 8 items, Professional help / Support with 5 items, Perceived Security / Memories with 6 items and Participation in Decisions with 3 items.
- Questions 1, 2, 4, 5, 6, 19, 20, 21 in the Birth Process sub-dimension;
- Questions 13, 14, 15, 16, 17 in the Professional help / Support sub-dimension;
- Questions 3, 7, 8, 9, 18, 22 in the Perceived Security / Memories sub-dimension;
- Questions 10, 11, 12 are included in the Participation in Decisions sub-dimension.
The first 19 items of the scale are in the four-point Likert type and are scored from 1 to 4.
- Completely agree = 1, • Mostly agree = 2, • Partially agree = 3, • Strongly disagree = 4.
The last three
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postnatal CareStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740682
- Sponsor's protocol ID
- 2024/11 GO 2024/596
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aslantas BN, Cankaya S. The effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction: a randomized controlled study. Arch Gynecol Obstet. 2024 Jun;309(6):2459-2474. doi: 10.1007/s00404-023-07115-4. Epub 2023 Jul 5.
PubMed 37405439Alizadeh-Dibazari Z, Abdolalipour S, Mirghafourvand M. The effect of prenatal education on fear of childbirth, pain intensity during labour and childbirth experience: a scoping review using systematic approach and meta-analysis. BMC Pregnancy Childbirth. 2023 Jul 27;23(1):541. doi: 10.1186/s12884-023-05867-0.
PubMed 37501120Abadi Marzoni Z, Bakouei F, Aghajani Delavar M, Hamidia A, Sepidarkish M. Midwife-led psycho-education intervention to reduce childbirth fear: a quasi-experimental study. Health Educ Res. 2024 May 11;39(3):245-253. doi: 10.1093/her/cyae017.
PubMed 38687635
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Potcost Stories on Childbirth Fear, Pain and Delivery Method
- ClinicalTrials.gov ID
- NCT06740682
- Acronym / sponsor ID
- 2024/11 GO 2024/596
- Conditions
- Postnatal Care
- Keywords
- Potcost Stories, fear, pain, experiences, birth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Fear of birth is affected by people's past traumatic birth experiences, lack of information, and the transfer of birth experiences experienced by individuals . Birth stories are one of the most accessible and frequently used tools for women to learn about birth. These stories are seen to affect women's fears of birth and their birth preferences .This study will evaluate the impact of Potcost Stories on childbirth-related fear, pain, experiences and mode of delivery.
Detailed description
Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Fear of birth is affected by people's past traumatic birth experiences, lack of information, and the transfer of birth experiences experienced by individuals . Birth stories are one of the most accessible and frequently used tools for women to learn about birth. These stories are seen to affect women's fears of birth and their birth preferences .The World Health Organization (WHO) has emphasized the importance of education given during pregnancy in reducing a positive birth experience and fear of birth. . Advances in technology have made podcasts, videos, and mobile phone applications (apps) widely used in training. As a result of these trainings, behavioral changes are observed in people. It has been reported that being supported by midwives during pregnancy and encouraging birth as a positive experience reduces the fear of birth . Therefore, sharing positive birth stories in pregnancy schools and antenatal care is of great importance. However, it is thought that using podcast stories and sharing women's positive birth experiences together will reduce fear during birth and increase vaginal birth. Therefore, in this study, a podcast of stories that pregnant women can listen to again whenever they want, including positive birth experiences, was prepared. This study aimed to determine the effects of potcost stories on fear, pain, satisfaction and birth outcomes related to birth. We aim for the findings and results of the study to contribute to the midwifery and nursing care literature.
This study will evaluate the effects of Potcost Stories on fear, pain, experiences and delivery type related to birth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Potcost Stories | Active comparator | Behavioral: Podcast olumlu doğum hikayeler |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Those who have completed at least primary school education
- Those who can speak, understand and write Turkish
- Those between the ages of 18-35
- Those who have spontaneous pregnancy
- Those who volunteer to participate in the study
Key exclusion criteria (5 listed)
- Those who have fear of childbirth
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 |
|---|---|---|
| Podcast olumlu doğum hikayelerositive birth stories were listened to by women who gave birth in the hospital included in the study and created with their permission. The podcast recording was done in a single session. These positive birth stories were expertly reviewed by 3 obstetricians and 3 academics. Each podcast content is 10 to 20 minutes (Cai et al., 2023). A WhatsApp reminder msg will be sent so that the stories are not forgotten. In addition, the pregnant woman will be contacted by phone and trained to listen (Cai et al., 2023). Participants will be allowed to listen to the podcasts as much as they want (Cai et al., 2023). After listening to each story, their feedback will be received and the participants' doubts will be clarified. (Cai et al., 2023; Çankaya and Şimşek, 2021; Mousavi et al., 2022). Based on multimedia principles, podcast positive birth experiences will be prepared (Clark and Mayer, 2023). Week 24, Week 30-32, Week 36-38 First story | Behavioural | Potcost Stories |
Primary outcome
Wijma Birth Expectation/Experience Scale (W-DEQ) Version A
Time frame: 1 MOUNT
The Wijma Birth Expectation/Experience Scale Version A (W-DEQ A), developed by K. Wijma et al. in Sweden in 1998, was adapted to Turkish by Körükçü et al. in 2012. The W-DEQ consists of 33 items and is a six-point Likert-type scale. The item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". The minimum score that can be obtained from the scale is 0, and the maximum score is 165. The cut-off value is 85 points, and a score of 85 and above is expressed as clinical fear. A high total scale score means that the degree of fear experienced is also high. * W-DEQ score ? 37 is mild, * W-DEQ score = 38-65 is moderate, * W-DEQ score = 66-84 is severe, * W-DEQ score ? 85 indicates clinical fear. Questions 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 in the scale are negatively loaded and are calculated by reversing in order to ensure compliance in the measurement. The Cronbach a
VASA Pain
Time frame: 1 HOUR
The numerical pain rating scale (NAS) is used to assess pain intensity. In the numerical rating scale, pain is rated between 0 (absence of pain) and 10 (unbearable pain) (Price et al., 1983)
Birth Experience Questionnaire (CEQ)
Time frame: 1 HOUR
The Birth Experience Questionnaire (CEQ), developed by Dencker et al. in 2010, was adapted to Turkish by Mamuk et al. in 2019. The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. It consists of the Birth process with 8 items, Professional help / Support with 5 items, Perceived Security / Memories with 6 items and Participation in Decisions with 3 items. * Questions 1, 2, 4, 5, 6, 19, 20, 21 in the Birth Process sub-dimension; * Questions 13, 14, 15, 16, 17 in the Professional help / Support sub-dimension; * Questions 3, 7, 8, 9, 18, 22 in the Perceived Security / Memories sub-dimension; * Questions 10, 11, 12 are included in the Participation in Decisions sub-dimension. The first 19 items of the scale are in the four-point Likert type and are scored from 1 to 4. • Completely agree = 1, • Mostly agree = 2, • Partially agree = 3, • Strongly disagree = 4. The last three
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 37405439Aslantas BN, Cankaya S. The effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction: a randomized controlled study. Arch Gynecol Obstet. 2024 Jun;309(6):2459-2474. doi: 10.1007/s00404-023-07115-4. Epub 2023 Jul 5.
- Results publication: PubMed 37501120Alizadeh-Dibazari Z, Abdolalipour S, Mirghafourvand M. The effect of prenatal education on fear of childbirth, pain intensity during labour and childbirth experience: a scoping review using systematic approach and meta-analysis. BMC Pregnancy Childbirth. 2023 Jul 27;23(1):541. doi: 10.1186/s12884-023-05867-0.
- Results publication: PubMed 38687635Abadi Marzoni Z, Bakouei F, Aghajani Delavar M, Hamidia A, Sepidarkish M. Midwife-led psycho-education intervention to reduce childbirth fear: a quasi-experimental study. Health Educ Res. 2024 May 11;39(3):245-253. doi: 10.1093/her/cyae017.
- Individual participant dataSharing planned: No
Related trials for Postnatal Care
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Recruiting
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
Digital Health, Maternal Health Services
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
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.
Questions about this trial
What is this clinical trial studying?
A study testing Podcast olumlu doğum hikayeler in people with Postnatal Care, run by Burdur Mehmet Akif Ersoy University.
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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MİNE GÖKDUMAN (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (time frame: 1 MOUNT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740682, which also lists 3 linked publications.
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 18 Dec 2024.