Perception of Traumatic BirthNCT06849440
Effectiveness of Childbirth Preparation Education
A study testing Training in people with Perception of Traumatic Birth and Perceived Stress, run by Antalya Bilim University at 1 site in Turkey (Türkiye).
Trial summary
The act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally. However, sometimes birth can be perceived as stressful and traumatic for women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perception of Traumatic Birth, Perceived Stress
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 9 May 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
28-34th weeks of pregnancy Agree to participate in the study Be literate Be able to speak and understand Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Childbirth Preparation Education on Perceived Stress and Traumatic Birth Perception in Pregnant Women
The act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally. However, sometimes birth can be perceived as stressful and traumatic for women. Stress during pregnancy is a problem that should be emphasized and managed due to its negative effects on the health of the mother and the baby. As the pregnancy progresses, the levels of stress hormones may increase. In addition, the thought of spontaneous birth exposes women to physical discomfort, stress and uncertainty during pregnancy. The perception of traumatic birth is an important concept that emerges as a result of the woman's mental birth scenario, the information she has acquired about birth, and every situation she experiences during the birth, and also affects the postpartum period. In studies conducted in Turkey using the Traumatic Birth Perception Scale, it was determined that 23.6% and 26.9% of women experienced a high level of traumatic birth perception. Nulliparity, negative feelings about birth, inadequate antenatal care, inadequate psychosocial support, risky pregnancies, and lack of information about birth are among the factors that may cause traumatic birth perception. Physical and mental preparation for birth and information about pain management are considered to be the basic elements of prenatal education classes. There are study results indicating that birth preparation classes benefit women in many aspects such as self-sufficiency, reduced fear of birth, and positive pregnancy experience. No study results have been found in the literature examining the effect of birth preparation education on the perception of traumatic birth during pregnancy. Based on this, this study was needed to examine the effect of pregnant women's participation in childbirth preparation training on their perceived stress level and perception of traumatic birth.
- Conditions
- Perception of Traumatic Birth, Perceived Stress
- Being tested
- Training
- Keywords
- childbirth, childbirth preparation, percieved stress, perception of traumatic birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Participants will be divided into groups of ten and the training is planned in 4 sessions. Session contents are prepared as sharing general information on preparation for birth, explanation of frequently applied interventions in labor, explanation of non-drug pain relieving methods, teaching and practicing active birth positions that help the labor progress. The duration of the sessions is planned as 2 hours on average.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | The sociodemographic data collection form and the perceived stress and traumatic birth perception scales as pre-tests will be applied to the pregnant women who accept the study before the childbirth training. After the pre-test, the pregnant women will be given face-to-face childbirth preparation training in a classroom environment during four sessions. When the participants complete the training sessions, the scales will be applied as a post-test. The data collection process will be completed after the application of the scales. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
It was developed by Cohen et al. (1983). The scale was adapted to Turkish by Eskin et al. (2013). The PSS, which consists of 14 items in total, was designed to measure the degree to which a number of situations in a person's life are perceived as stressful. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". 7 of the items containing positive expressions are scored reversely. Scores vary between 0 and 56. A high score indicates a high perception of stress. In the study by Eskin et al., the Cronbach's alpha value of the scale was found to be 0.84.
Measured: Pre-test and immediately post-test
Secondary outcomes (1)
Traumatic Birth Perception Scale (TBPS)
The Traumatic Birth Perception Scale (TBPS) was developed by Yalnız et al. (2016) to determine the perception of traumatic birth, and its validity and reliability studies were conducted. The original study was conducted on women aged 18-40. The final version of the scale consists of 13 items. Each item is in the form of an ordinal scale and is scored between 1 (lowest score) and 10 (highest score). The scores obtained from each item are added together. As the score obtained from the scale increases, it shows that the level of perception of birth as traumatic increases. The score obtained from the scale varies between 0 and 130. According to the total score of the scale; 0-26 points indicate "very low", 27-52 points indicate "low", 53-78 points indicate "medium", 79-104 points indicate "high", and 105-130 points indicate "very high" level of perception of traumatic birth. The Cronbach alpha value was found to be 0.89 in the original study of the scale.
Measured: Pre-test and immediately post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perception of Traumatic BirthStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849440
- Sponsor's protocol ID
- 2025-101
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Childbirth Preparation Education on Perceived Stress and Traumatic Birth Perception in Pregnant Women
- ClinicalTrials.gov ID
- NCT06849440
- Acronym / sponsor ID
- 2025-101
- Conditions
- Perception of Traumatic Birth, Perceived Stress
- Keywords
- childbirth, childbirth preparation, percieved stress, perception of traumatic birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 27 Feb 2025 (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 act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally. However, sometimes birth can be perceived as stressful and traumatic for women. Stress during pregnancy is a problem that should be emphasized and managed due to its negative effects on the health of the mother and the baby. As the pregnancy progresses, the levels of stress hormones may increase. In addition, the thought of spontaneous birth exposes women to physical discomfort, stress and uncertainty during pregnancy. The perception of traumatic birth is an important concept that emerges as a result of the woman's mental birth scenario, the information she has acquired about birth, and every situation she experiences during the birth, and also affects the postpartum period. In studies conducted in Turkey using the Traumatic Birth Perception Scale, it was determined that 23.6% and 26.9% of women experienced a high level of traumatic birth perception. Nulliparity, negative feelings about birth, inadequate antenatal care, inadequate psychosocial support, risky pregnancies, and lack of information about birth are among the factors that may cause traumatic birth perception. Physical and mental preparation for birth and information about pain management are considered to be the basic elements of prenatal education classes. There are study results indicating that birth preparation classes benefit women in many aspects such as self-sufficiency, reduced fear of birth, and positive pregnancy experience. No study results have been found in the literature examining the effect of birth preparation education on the perception of traumatic birth during pregnancy. Based on this, this study was needed to examine the effect of pregnant women's participation in childbirth preparation training on their perceived stress level and perception of traumatic birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: TrainingThe sociodemographic data collection form and the perceived stress and traumatic birth perception scales as pre-tests will be applied to the pregnant women who accept the study before the childbirth training. After the pre-test, the pregnant women will be given face-to-face childbirth preparation training in a classroom environment during four sessions. When the participants complete the training sessions, the scales will be applied as a post-test. The data collection process will be completed after the application of the scales. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| TrainingParticipants will be divided into groups of ten and the training is planned in 4 sessions. Session contents are prepared as sharing general information on preparation for birth, explanation of frequently applied interventions in labor, explanation of non-drug pain relieving methods, teaching and practicing active birth positions that help the labor progress. The duration of the sessions is planned as 2 hours on average. | Behavioural | Training group |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: Pre-test and immediately post-test
It was developed by Cohen et al. (1983). The scale was adapted to Turkish by Eskin et al. (2013). The PSS, which consists of 14 items in total, was designed to measure the degree to which a number of situations in a person's life are perceived as stressful. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". 7 of the items containing positive expressions are scored reversely. Scores vary between 0 and 56. A high score indicates a high perception of stress. In the study by Eskin et al., the Cronbach's alpha value of the scale was found to be 0.84.
1 secondary outcome
Traumatic Birth Perception Scale (TBPS)
Time frame: Pre-test and immediately post-test
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 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Perception of Traumatic Birth and Perceived Stress, run by Antalya Bilim 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?
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 Aug 2025. 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?
Perceived Stress Scale (PSS) (time frame: Pre-test and immediately post-test). 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 Aug 2025.