BirthNCT07382609
The Effect of Creating a Birth Story in the Labor Room on Fear of Childbirth
A study testing BIRTH STORY EXPERIMENTAL GROUP in people with Birth, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to reduce the fears of women who will give birth and increase their comfort. In the literature review conducted for this purpose, no study has yet been found that examines the effect of creating a birth story in the labor room on the fear of birth and birth comfort in primiparous pregnant… 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
- Birth
- What is being tested?
- BIRTH STORY EXPERIMENTAL GROUP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Jan 2026
- 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
- Pregnant women with an indication for caesarean section during the latent phase of labour will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Creating a Birth Story in the Labor Room on Fear of Childbirth and Birth Comfort in Primiparous Pregnant Women
The aim of this study is to reduce the fears of women who will give birth and increase their comfort. In the literature review conducted for this purpose, no study has yet been found that examines the effect of creating a birth story in the labor room on the fear of birth and birth comfort in primiparous pregnant women. In order to fill this gap in the literature, pregnant women in the labor room will be asked to create their birth stories and the effect of this on fear of birth and birth comfort will be examined.
The hypotheses of the study are as follows:
H1a: Creating a birth story in the labor room affects fear of birth H1b: Creating a birth story in the labor room affects birth comfort.
Read the detailed description
The aim of this study is to examine the effect of creating a birth story in the labor room on the fear of childbirth and the comfort of pregnant women. Data will be collected from primiparous pregnant women who are admitted to the labor room in the maternity ward of Gölbaşı State Hospital and are in the latent phase. Women will be informed about the study and will be asked whether they will participate in the study. Informed consent forms will be distributed to women who agree to participate in the study. Data collection tools will be applied to women who agree to participate in the study by the researcher through face-to-face interviews. Data collection will be completed with the end of the latent phase (≥ 4-6 cm). No intervention will be applied to women in the control group, however, the Personal Information Form, Prenatal Self-Assessment Scale-Fear of Childbirth Subscale and Childbirth Comfort Scale will be applied simultaneously with the experimental group. Pre-test data collection questionnaires will be applied to pregnant women in the experimental group at the beginning of the latent phase and pregnant women will be asked to create their own birth stories. A transparent wall board will be attached to the wall of the labor room and pregnant women will be given appropriate pens and asked to write their feelings and thoughts on this board and in this way, birth stories will be created. If pregnant women wish, their photographs will be taken and attached to this board. After the birth story is created, the post-test data collection tools will be applied to the pregnant woman again and the data collection process will be completed.
- Conditions
- Birth
- Being tested
- BIRTH STORY EXPERIMENTAL GROUP
- Keywords
- comfort, fear of birth, pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRTH STORY EXPERIMENTAL GROUPBehavioural
The birth story is created by the pregnant women in the labor room writing their feelings on a transparent wallpaper attached to the wall. The pregnant woman, the midwife, the father and the doctor can also write their feelings and thoughts on this wallpaper. In this way, the pregnant woman looks at the wall on which positive thoughts are written throughout the labor and thus the fear of birth is reduced.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: | No intervention | GROUP WITHOUT BIRTH STORY |
| Experimental | Experimental | Birth story creating group Receives: Behavioral: BIRTH STORY EXPERIMENTAL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Self Evaluation Questionnaire score
The scale developed by Lederman determines women's adaptation to pregnancy and motherhood. This scale is a 4-point Likert-type scale with 7 sub-dimensions and 79 items. The scores that can be obtained from the scale are between 10 and 40.
Measured: Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]
Secondary outcomes (1)
Childbirth Comfort Questionnaire- CCQ score
The scale consists of 9 questions and is a 5-point Likert type (1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, 5=Totally agree). The items are expected to be answered considering the comfort of the delivery room. Each statement reports a certain sense of comfort (relaxation, relief or superiority) and dimensions (physical, environmental, psychospiritual or social). A minimum of 9 and a maximum of 45 points can be obtained from the scale. It can be thought that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.
Measured: Immediately prior to active labor (at 4 cm cervical dilatation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2024
- Primary completion1 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Crossover
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Tan, Inonu University
- Investigators
- Esra GÜNEY, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382609
- Sponsor's protocol ID
- 5499
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Creating a Birth Story in the Labor Room on Fear of Childbirth and Birth Comfort in Primiparous Pregnant Women
- ClinicalTrials.gov ID
- NCT07382609
- Acronym / sponsor ID
- 5499
- Conditions
- Birth
- Keywords
- comfort, fear of birth, pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 3 Feb 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.
The aim of this study is to reduce the fears of women who will give birth and increase their comfort. In the literature review conducted for this purpose, no study has yet been found that examines the effect of creating a birth story in the labor room on the fear of birth and birth comfort in primiparous pregnant women. In order to fill this gap in the literature, pregnant women in the labor room will be asked to create their birth stories and the effect of this on fear of birth and birth comfort will be examined.
The hypotheses of the study are as follows:
H1a: Creating a birth story in the labor room affects fear of birth H1b: Creating a birth story in the labor room affects birth comfort.
Detailed description
The aim of this study is to examine the effect of creating a birth story in the labor room on the fear of childbirth and the comfort of pregnant women. Data will be collected from primiparous pregnant women who are admitted to the labor room in the maternity ward of Gölbaşı State Hospital and are in the latent phase. Women will be informed about the study and will be asked whether they will participate in the study. Informed consent forms will be distributed to women who agree to participate in the study. Data collection tools will be applied to women who agree to participate in the study by the researcher through face-to-face interviews. Data collection will be completed with the end of the latent phase (≥ 4-6 cm). No intervention will be applied to women in the control group, however, the Personal Information Form, Prenatal Self-Assessment Scale-Fear of Childbirth Subscale and Childbirth Comfort Scale will be applied simultaneously with the experimental group. Pre-test data collection questionnaires will be applied to pregnant women in the experimental group at the beginning of the latent phase and pregnant women will be asked to create their own birth stories. A transparent wall board will be attached to the wall of the labor room and pregnant women will be given appropriate pens and asked to write their feelings and thoughts on this board and in this way, birth stories will be created. If pregnant women wish, their photographs will be taken and attached to this board. After the birth story is created, the post-test data collection tools will be applied to the pregnant woman again and the data collection process will be completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: | No intervention | –GROUP WITHOUT BIRTH STORY |
| Experimental | Experimental | Behavioral: BIRTH STORY EXPERIMENTAL GROUPBirth story creating group |
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)
- Pregnant women with an indication for caesarean section during the latent phase of labour will not be included in the study.
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 |
|---|---|---|
| BIRTH STORY EXPERIMENTAL GROUPThe birth story is created by the pregnant women in the labor room writing their feelings on a transparent wallpaper attached to the wall. The pregnant woman, the midwife, the father and the doctor can also write their feelings and thoughts on this wallpaper. In this way, the pregnant woman looks at the wall on which positive thoughts are written throughout the labor and thus the fear of birth is reduced. | Behavioural | Experimental |
Primary outcome
Prenatal Self Evaluation Questionnaire score
Time frame: Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]
The scale developed by Lederman determines women's adaptation to pregnancy and motherhood. This scale is a 4-point Likert-type scale with 7 sub-dimensions and 79 items. The scores that can be obtained from the scale are between 10 and 40.
1 secondary outcome
Childbirth Comfort Questionnaire- CCQ score
Time frame: Immediately prior to active labor (at 4 cm cervical dilatation)
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 3 Feb 2026.
- Description Reference linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared.
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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.
Esra GÜNEY, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIRTH STORY EXPERIMENTAL GROUP in people with Birth, run by Inonu University 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 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 3 Feb 2026. 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?
Prenatal Self Evaluation Questionnaire score (time frame: Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]). 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 3 Feb 2026.