Fear of ChildbirthNCT05131503
Evaluation of The Fear of Childbirth
An observational study of Fear of Childbirth, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Most pregnant women have fear of labor. The reasons of fear of labor are different according to women. The investigators will examine the relationship between the descriptive features and level of fear of labor of pregnant women by using the Oxford worries about labour scale Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Survey Research
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 15 Mar 2022
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: they are healthy pregnant women who are 18-35 years old. they do not have any obstetrical complications. they go to the antenatal polyclinic.
Who may be able to join
- all of volunteers and pregnant women who are 18-35 years old.
Who cannot join
- the pregnant women have any obstetrical complications.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital- Maternity Hospital
Ankara, Çankaya
About this study
Official title: Evaluation of The Fear of Childbirth in Pregnant Women Who Are In The Antenatal Polyclinic: The Sample of Turkey
Most pregnant women have fear of labor. The reasons of fear of labor are different according to women. The investigators will examine the relationship between the descriptive features and level of fear of labor of pregnant women by using the Oxford worries about labour scale
Read the detailed description
The investigators will give a survey to pregnant women who go to the antenatal polyclinic. The survey is consisted by researchers. The survey has a few questions about pregnant women's descriptive features. Next the investigators will evaluate the level of fear of labor of pregnant women. After the investigators will analyze the relationship between pregnant women's fear and their descriptive features.
- Conditions
- Fear of Childbirth
- Being tested
- Survey Research
- Keywords
- fear, Parturition, midwifery, Pregnant Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey ResearchOther
Non-applicable. There is no intervention. This study is descriptive research.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oxford Worries About Labour Scale
This scale measures the level of fear of childbirth. The scale has ten questions which has four answers as Likert Scale. Also the scale has 40-100 points. As the point decreases the fear score increases.
Measured: approximately 30 minutes, waiting in the antenatal polyclinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Sep 2021
- Primary completion15 Jan 2022
- Study completion15 Mar 2022
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 Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nükhet Kaçar, Ankara City Hospital Bilkent
- Investigators
- Nükhet Kaçar, MSc., Principal investigator, Ankara City Hospital- Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131503
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-NK-02
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Fear of Childbirth in Pregnant Women Who Are In The Antenatal Polyclinic: The Sample of Turkey
- ClinicalTrials.gov ID
- NCT05131503
- Acronym / sponsor ID
- AnkaraCHBilkent-MH-NK-02
- Conditions
- Fear of Childbirth
- Keywords
- fear, Parturition, midwifery, Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 Nov 2021 (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.
Most pregnant women have fear of labor. The reasons of fear of labor are different according to women. The investigators will examine the relationship between the descriptive features and level of fear of labor of pregnant women by using the Oxford worries about labour scale
Detailed description
The investigators will give a survey to pregnant women who go to the antenatal polyclinic. The survey is consisted by researchers. The survey has a few questions about pregnant women's descriptive features. Next the investigators will evaluate the level of fear of labor of pregnant women. After the investigators will analyze the relationship between pregnant women's fear and their descriptive features.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- they are healthy pregnant women who are 18-35 years old. they do not have any obstetrical complications. they go to the antenatal polyclinic.
Key inclusion criteria (1 listed)
- all of volunteers and pregnant women who are 18-35 years old.
Key exclusion criteria (1 listed)
- the pregnant women have any obstetrical complications.
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 |
|---|---|---|
| Survey ResearchNon-applicable. There is no intervention. This study is descriptive research. | Other | – |
Primary outcome
The Oxford Worries About Labour Scale
Time frame: approximately 30 minutes, waiting in the antenatal polyclinic.
This scale measures the level of fear of childbirth. The scale has ten questions which has four answers as Likert Scale. Also the scale has 40-100 points. As the point decreases the fear score increases.
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 27 Jul 2022.
- Individual participant dataSharing planned: No
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Mandala Coloring in Late Pregnancy
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Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
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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.
Nükhet Kaçar, MSc. principal investigator
Ankara City Hospital- Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Childbirth, run by Ankara City Hospital Bilkent at 1 site 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 1 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The Oxford Worries About Labour Scale (time frame: approximately 30 minutes, waiting in the antenatal polyclinic.). 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 27 Jul 2022.