Pregnant WomenNCT06637735
The Effect of Education on Pregnant Women Perception of Traumatic Childbirth
A study testing education in people with Pregnant Women and Education, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
During pregnancy, women are exposed to physical, psychological and social changes and may experience anxiety and fears about childbirth. Traumatic birth perception is defined as perceiving birth as a threat to oneself and one\'s baby. 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
- Pregnant Women, Education
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Sep 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
Eligibility criteria The same eligibility criteria applied to both groups. Pregnant women were eligible if they agreed to participate, were aged 18 years or older, scored at least 53 on the Traumatic Childbirth Perception Scale and had internet access. They were also required to have no pregnancy-related risk conditions, such as pre-eclampsia, gestational diabetes, cardiac complications, placenta praevia or oligohydramnios, and no fetal health problems, such as fetal anomalies or fetal growth restriction.
Women were excluded if they were unable to read and write, had a diagnosed psychiatric or psychological disorder, or had communication or language difficulties.
Exclusion Criteria: - Refused to participate in the research,
- Illiterate,
- Has a disorder based on a psychiatric/psychological diagnosis,
- Pregnant women with communication and language problems will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Pregnant Women on the Perception of Traumatic Childbirth
During pregnancy, women are exposed to physical, psychological and social changes and may experience anxiety and fears about childbirth. Traumatic birth perception is defined as perceiving birth as a threat to oneself and one\'s baby. This perception can negatively affect women\'s lives in the postpartum period. Midwives are the primary health professionals in preventing traumatic birth perception. In this context, it is envisaged to create an important basis for preventing traumatic birth perception in pregnant women through the training to be given.
Read the detailed description
Supporting a positive childbirth experience is a central aim of woman-centred maternity care (World Health Organization [WHO], 2018). During pregnancy, some women perceive childbirth as a threat to themselves or their baby. Higher traumatic childbirth perception has been associated with health anxiety and doubts about the ability to cope with labour (Türkmen et al., 2021). In the antenatal context, this perception concerns how women view childbirth before it occurs. It should be distinguished from psychological birth trauma arising from an actual birth experience (Sun et al., 2023). This distinction matters when considering what antenatal interventions can achieve.
Antenatal education may help women prepare for birth and address their concerns. A scoping review with meta-analysis found that prenatal education may reduce fear of childbirth, although limitations in the available evidence prevented firm conclusions (Alizadeh-Dibazari et al., 2023). Online delivery also offers a way to provide education without requiring attendance in person. In a randomised controlled trial conducted during the COVID-19 pandemic, online antenatal education reduced worries about labour and fear of childbirth and improved preparedness for labour (Uludağ et al., 2022). These findings support further investigation of online education, but do not establish its effect on traumatic childbirth perception, which is a different outcome from fear of childbirth.
E-health literacy is also relevant to education delivered online. It encompasses the skills needed to locate, understand and critically assess digital health information and use it to inform health decisions (Norman \& Skinner, 2006). These skills may influence how women interpret information about childbirth and engage with online education. Whether e-health literacy is associated with traumatic childbirth perception, and whether it modifies the effect of an educational intervention, are therefore separate questions that warrant investigation.
This study aimed to evaluate the effect of online antenatal education on traumatic childbirth perception among pregnant women in Türkiye, examine its association with e-health literacy, and determine whether e-health literacy moderated the intervention effect.
Statement of significance Problem or Issue Traumatic childbirth perception during pregnancy is associated with health anxiety and doubts about coping with labour, yet accessible antenatal interventions targeting it are limited.
What is Already Known Antenatal education may reduce fear of childbirth and improve preparedness. Evidence concerning online education and traumatic childbirth perception remains limited.
What this Paper Adds In this randomised controlled trial, a single structured online antenatal education session reduced traumatic childbirth perception scores among women with moderate or higher baseline scores. The reduction was maintained at one-month follow-up. No evidence was found that baseline e-health literacy moderated the intervention effect.
Methods Study design This was a two-arm, parallel-group randomised controlled trial. The trial is reported in accordance with the CONSORT 2025 statement (Hopewell et al., 2025). The trial was retrospectively registered with ClinicalTrials.gov (NCTXXX).
Setting Data were collected between July and December 2024 at the obstetrics outpatient clinic of XXX Maternity and Children's Hospital, a public hospital in XXX, Türkiye.
Participants and sample size Participants were recruited from pregnant women attending the clinic who scored at least 53 on the Traumatic Childbirth Perception Scale.
An a priori power analysis was conducted using G*Power version 3.1.9.7 (Faul et al., 2007) for a two-tailed independent-samples t-test. Assuming a large effect size (d = 0.80; Cohen, 1988), a significance level of 0.05 and 80% power, the required sample size was calculated as 52 women, with 26 per group. To allow for potential attrition, the planned sample was increased to 62 women, with 31 per group. All eligible women who consented during the recruitment period were included; therefore, 70 women were randomised (35 per group), and 64 completed the study and were included in the analyses, with 32 per group. Participant flow is shown in Figure 1.
Eligibility criteria The same eligibility criteria applied to both groups. Pregnant women were eligible if they agreed to participate, were aged 18 years or older, scored at least 53 on the Traumatic Childbirth Perception Scale and had internet access. They were also required to have no pregnancy-related risk conditions, such as pre-eclampsia, gestational diabetes, cardiac complications, placenta praevia or oligohydramnios, and no fetal health problems, such as fetal anomalies or fetal growth restriction.
Women were excluded if they were unable to read and write, had a diagnosed psychiatric or psychological disorder, or had communication or language difficulties.
Randomisation and blinding Randomisation was performed after recruitment had been completed and all enrolled women had completed the baseline assessment. Participants were allocated to the intervention or control group in a 1:1 ratio using block randomisation with fixed blocks of four (two per group); as 70 women were randomised, the final block was incomplete, resulting in 35 women in each group. The allocation sequence was generated by an independent statistician using a random number table. Each participant was given an individual study code, and the statistician assigned the codes to groups according to the sequence. The researchers were informed of group allocation only after baseline assessment and before the intervention was delivered.
Owing to the nature of the intervention, neither the participants nor the researcher delivering the education could be blinded. Outcomes were self-reported by participants, face to face at baseline and online at post-test and follow-up. To reduce bias during analysis, one researcher entered the data with the groups coded as 'Group 1' and 'Group 2', and the statistical analyses were performed by another researcher who was not involved in data collection and was blinded to which code corresponded to which group.
Data collection instruments Participant characteristics form This form was developed based on the literature (Solhi et al., 2019; Türkmen et al., 2021; Uludağ et al., 2022). It included questions on sociodemographic characteristics (age, educational level and chronic illness) and obstetric and birth-related characteristics (number of pregnancies, mode of last birth, planned pregnancy, antenatal education in the current pregnancy, having heard or watched others' birth stories, having accompanied a relative giving birth in hospital, and lifetime exposure to verbal or physical violence).
Traumatic Childbirth Perception Scale The Traumatic Childbirth Perception Scale (TCPS) was developed in Türkiye by Yalnız et al. (2016) to assess the extent to which women perceive childbirth as traumatic. It comprises 13 items assessing women's thoughts about giving birth, each scored from 0 (positive thoughts) to 10 (negative thoughts). Total scores range from 0 to 130, with higher scores indicating greater traumatic childbirth perception. Scores are classified as very low (0-26), low (27-52), moderate (53-78), high (79-104) or very high (105-130). Cronbach's alpha was 0.89 in the original study (Yalnız et al., 2016) and 0.73 at baseline, 0.96 at post-test and 0.97 at follow-up in the present study.
E-health Literacy Scale for Pregnant Women The E-health Literacy Scale for Pregnant Women (eHEALS-PW) was developed by Ada (2025). It comprises 13 items across two subscales: information access and application, and information reliability and awareness. Items are rated on a 5-point Likert scale, giving total scores of 13 to 65, with higher scores indicating higher e-health literacy. The scale has no reverse-scored items and no cut-off score. In the development study, Cronbach's alpha was 0.93 for the total scale and 0.89 to 0.91 for the subscales (Ada, 2025). In the present study, Cronbach's alpha was 0.89.
Intervention Theoretical framework The programme was based on Beck's (2015) middle range theory of traumatic childbirth, which describes the long-term consequences of traumatic birth for women, the mother-infant relationship, partners and the healthcare professionals present. Beck identifies loss of control, lack of respect and inadequate communication as central to traumatic childbirth and emphasises prevention. Accordingly, the programme aimed to help women anticipate situations they might encounter during labour and birth, manage their expectations, strengthen their sense of control and identify sources of support. Online delivery was chosen to improve access by enabling women to participate without attending a physical venue.
Educational content The programme covered three main areas: (1) female reproductive anatomy, the menstrual cycle, fertilisation and the physiological, systemic and psychological changes of pregnancy; (2) health in pregnancy, including common symptoms and their management, nutrition and fluid intake, smoking and alcohol use, sexual life, exercise, antenatal care and danger signs; and (3) preparation for birth, including the psychology of childbirth, the stages and process of labour, pushing techniques, non-pharmacological pain relief methods and atraumatic birth. Content on labour, pain relief and atraumatic birth was intended to help women anticipate what might happen during birth and strengthen their sense of control, in line with Beck's framework.
Development and review of the educational materials The educational content was independently reviewed by 13 experts in midwifery and obstetric and gynaecological nursing. The DISCERN instrument and the Evaluation of the Suitability of Written Materials form were used to assess the quality and suitability of the materials.
DISCERN instrument: DISCERN was developed by Charnock et al. (1999) to assess the quality of written consumer health information about treatment choices. The original instrument comprises 16 items organised into three sections addressing reliability, the quality of information about treatment choices and overall quality. In the present study, assessment was based on the first 15 items. Each item was rated on a five-point scale, with 1 indicating 'no', 3 'partially' and 5 'yes'. Item scores were summed to give a total ranging from 15 to 75, with higher scores indicating better information quality. The mean total score awarded by the 13 experts was 69.77 (1.74) out of a possible 75.
Evaluation of the Suitability of Written Materials form: The suitability of the materials was assessed using the 27-item Evaluation of the Suitability of Written Materials form, originally based on Doak et al. (1996) and adapted into Turkish by Demir et al. (2008). The form comprises six sections covering content, literacy demands, pictures and graphics, layout and typography, learning and motivation, and cultural appropriateness. Responses were scored as 1 for 'yes' and 0 for 'no', except for the negatively worded items 18, 20, 21 and 22, which were reverse-scored. Item scores were summed to give a total ranging from 0 to 27, with higher scores indicating greater suitability. The mean total score awarded by the 13 experts was 24.92 (0.95) out of a possible 27.
Intervention delivery Women in both groups were contacted via WhatsApp to arrange the sessions and data collection. The intervention was delivered by the first author, a midwife and academic with clinical experience in labour and birth care. Sessions were held via Zoom in groups of four, with each group scheduled on a different day. Each session comprised 45 minutes of education, a 15-minute break and a 45-minute question-and-answer session. Teaching methods included verbal explanation, discussion, slide presentations and questions and answers, which were used to encourage active participation and give women opportunities to discuss their concerns. All 32 women in the intervention group who were included in the analysis completed the educational session. Gestational age was not an eligibility criterion and therefore varied among participants. After the study was completed, women in the control group were given an information booklet covering the topics of the education so that they would not be deprived of the information.
Pretesting of the participant characteristics form Sample size recommendations for pilot studies vary, and the number of participants should be guided by the purpose of the preliminary assessment (In, 2017). In the present study, the participant characteristics form was pretested with 20 pregnant women attending the outpatient clinic to assess whether the questions were understandable. The women reported that the form was clear, and no changes were made following pretesting. Women who participated in pretesting were not included in either the intervention or control group.
Data collection After the necessary approvals had been obtained, the head of the obstetrics outpatient clinic at XXX Maternity and Children's Hospital and the midwives and nurses working there were informed about the purpose and scope of the study. The study was explained to pregnant women waiting for their outpatient appointments, and verbal and written informed consent was obtained from those who agreed to participate. Women then completed the participant characteristics form, the TCPS and the eHEALS-PW face to face at the clinic; this served as both the eligibility screening and the baseline assessment. Women who scored at least 53 on the TCPS and met the other eligibility criteria were randomised as described above.
TCPS scores were collected at three time points: baseline, immediately after the session (post-test) and one month after the post-test (follow-up). The participant characteristics form and the eHEALS-PW were administered at baseline only. All educational sessions were completed within a one-month period, and post-test and follow-up assessments were completed online. Women in the control group, who received routine antenatal care only, completed the assessments at corresponding time points scheduled according to the session dates of the intervention groups.
- Conditions
- Pregnant Women, Education
- Being tested
- education
- Keywords
- education, pregnancy, traumatic childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
All educational sessions were completed within a one-month period, and post-test and follow-up assessments were completed online. Women in the control group, who received routine antenatal care only, completed the assessments at corresponding time points scheduled according to the session dates of the intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Women in both groups were contacted via WhatsApp to arrange the sessions and data collection. The intervention was delivered by the first author, a midwife and academic with clinical experience in labour and birth care. Sessions were held via Zoom in groups of four, with each group scheduled on a different day. Each session comprised 45 minutes of education, a 15-minute break and a 45-minute question-and-answer session. Teaching methods included verbal explanation, discussion, slide presentations and questions and answers, which were used to encourage active participation and give women opportunities to discuss their concerns. All 32 women in the intervention group who were included in the analysis completed the educational session. Gestational age was not an eligibility criterion and therefore varied among participants. Receives: Other: education |
| control | No intervention | No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-test post-test
The traumatic Childbirth Perception scale in pregnant women will be used as a pre-test and post-test. The experimental and control groups of the study will consist of pregnant women who scored at least 53 points on the Traumatic Childbirth Perception Scale. The minimum traumatic birth perception scale score is 0, and the maximum is 130. Scale total score 0-26 points range is very low, 27-52 points range is low, 53-78 points range is medium, 79-104 points range is high, and 105-130 points range is very high traumatic birth perception level.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental and control group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLESER ADA, Sakarya University
- Investigators
- Güleser ADA, Master, Study chair, sakarya üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637735
- Sponsor's protocol ID
- SAU-EBE-GA-01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2024
- Last updated
- 27 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Pregnant Women on the Perception of Traumatic Childbirth
- ClinicalTrials.gov ID
- NCT06637735
- Acronym / sponsor ID
- SAU-EBE-GA-01
- Conditions
- Pregnant Women, Education
- Keywords
- education, pregnancy, traumatic childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Oct 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.
During pregnancy, women are exposed to physical, psychological and social changes and may experience anxiety and fears about childbirth. Traumatic birth perception is defined as perceiving birth as a threat to oneself and one\'s baby. This perception can negatively affect women\'s lives in the postpartum period. Midwives are the primary health professionals in preventing traumatic birth perception. In this context, it is envisaged to create an important basis for preventing traumatic birth perception in pregnant women through the training to be given.
Detailed description
Supporting a positive childbirth experience is a central aim of woman-centred maternity care (World Health Organization [WHO], 2018). During pregnancy, some women perceive childbirth as a threat to themselves or their baby. Higher traumatic childbirth perception has been associated with health anxiety and doubts about the ability to cope with labour (Türkmen et al., 2021). In the antenatal context, this perception concerns how women view childbirth before it occurs. It should be distinguished from psychological birth trauma arising from an actual birth experience (Sun et al., 2023). This distinction matters when considering what antenatal interventions can achieve.
Antenatal education may help women prepare for birth and address their concerns. A scoping review with meta-analysis found that prenatal education may reduce fear of childbirth, although limitations in the available evidence prevented firm conclusions (Alizadeh-Dibazari et al., 2023). Online delivery also offers a way to provide education without requiring attendance in person. In a randomised controlled trial conducted during the COVID-19 pandemic, online antenatal education reduced worries about labour and fear of childbirth and improved preparedness for labour (Uludağ et al., 2022). These findings support further investigation of online education, but do not establish its effect on traumatic childbirth perception, which is a different outcome from fear of childbirth.
E-health literacy is also relevant to education delivered online. It encompasses the skills needed to locate, understand and critically assess digital health information and use it to inform health decisions (Norman \& Skinner, 2006). These skills may influence how women interpret information about childbirth and engage with online education. Whether e-health literacy is associated with traumatic childbirth perception, and whether it modifies the effect of an educational intervention, are therefore separate questions that warrant investigation.
This study aimed to evaluate the effect of online antenatal education on traumatic childbirth perception among pregnant women in Türkiye, examine its association with e-health literacy, and determine whether e-health literacy moderated the intervention effect.
Statement of significance Problem or Issue Traumatic childbirth perception during pregnancy is associated with health anxiety and doubts about coping with labour, yet accessible antenatal interventions targeting it are limited.
What is Already Known Antenatal education may reduce fear of childbirth and improve preparedness. Evidence concerning online education and traumatic childbirth perception remains limited.
What this Paper Adds In this randomised controlled trial, a single structured online antenatal education session reduced traumatic childbirth perception scores among women with moderate or higher baseline scores. The reduction was maintained at one-month follow-up. No evidence was found that baseline e-health literacy moderated the intervention effect.
Methods Study design This was a two-arm, parallel-group randomised controlled trial. The trial is reported in accordance with the CONSORT 2025 statement (Hopewell et al., 2025). The trial was retrospectively registered with ClinicalTrials.gov (NCTXXX).
Setting Data were collected between July and December 2024 at the obstetrics outpatient clinic of XXX Maternity and Children's Hospital, a public hospital in XXX, Türkiye.
Participants and sample size Participants were recruited from pregnant women attending the clinic who scored at least 53 on the Traumatic Childbirth Perception Scale.
An a priori power analysis was conducted using G*Power version 3.1.9.7 (Faul et al., 2007) for a two-tailed independent-samples t-test. Assuming a large effect size (d = 0.80; Cohen, 1988), a significance level of 0.05 and 80% power, the required sample size was calculated as 52 women, with 26 per group. To allow for potential attrition, the planned sample was increased to 62 women, with 31 per group. All eligible women who consented during the recruitment period were included; therefore, 70 women were randomised (35 per group), and 64 completed the study and were included in the analyses, with 32 per group. Participant flow is shown in Figure 1.
Eligibility criteria The same eligibility criteria applied to both groups. Pregnant women were eligible if they agreed to participate, were aged 18 years or older, scored at least 53 on the Traumatic Childbirth Perception Scale and had internet access. They were also required to have no pregnancy-related risk conditions, such as pre-eclampsia, gestational diabetes, cardiac complications, placenta praevia or oligohydramnios, and no fetal health problems, such as fetal anomalies or fetal growth restriction.
Women were excluded if they were unable to read and write, had a diagnosed psychiatric or psychological disorder, or had communication or language difficulties.
Randomisation and blinding Randomisation was performed after recruitment had been completed and all enrolled women had completed the baseline assessment. Participants were allocated to the intervention or control group in a 1:1 ratio using block randomisation with fixed blocks of four (two per group); as 70 women were randomised, the final block was incomplete, resulting in 35 women in each group. The allocation sequence was generated by an independent statistician using a random number table. Each participant was given an individual study code, and the statistician assigned the codes to groups according to the sequence. The researchers were informed of group allocation only after baseline assessment and before the intervention was delivered.
Owing to the nature of the intervention, neither the participants nor the researcher delivering the education could be blinded. Outcomes were self-reported by participants, face to face at baseline and online at post-test and follow-up. To reduce bias during analysis, one researcher entered the data with the groups coded as 'Group 1' and 'Group 2', and the statistical analyses were performed by another researcher who was not involved in data collection and was blinded to which code corresponded to which group.
Data collection instruments Participant characteristics form This form was developed based on the literature (Solhi et al., 2019; Türkmen et al., 2021; Uludağ et al., 2022). It included questions on sociodemographic characteristics (age, educational level and chronic illness) and obstetric and birth-related characteristics (number of pregnancies, mode of last birth, planned pregnancy, antenatal education in the current pregnancy, having heard or watched others' birth stories, having accompanied a relative giving birth in hospital, and lifetime exposure to verbal or physical violence).
Traumatic Childbirth Perception Scale The Traumatic Childbirth Perception Scale (TCPS) was developed in Türkiye by Yalnız et al. (2016) to assess the extent to which women perceive childbirth as traumatic. It comprises 13 items assessing women's thoughts about giving birth, each scored from 0 (positive thoughts) to 10 (negative thoughts). Total scores range from 0 to 130, with higher scores indicating greater traumatic childbirth perception. Scores are classified as very low (0-26), low (27-52), moderate (53-78), high (79-104) or very high (105-130). Cronbach's alpha was 0.89 in the original study (Yalnız et al., 2016) and 0.73 at baseline, 0.96 at post-test and 0.97 at follow-up in the present study.
E-health Literacy Scale for Pregnant Women The E-health Literacy Scale for Pregnant Women (eHEALS-PW) was developed by Ada (2025). It comprises 13 items across two subscales: information access and application, and information reliability and awareness. Items are rated on a 5-point Likert scale, giving total scores of 13 to 65, with higher scores indicating higher e-health literacy. The scale has no reverse-scored items and no cut-off score. In the development study, Cronbach's alpha was 0.93 for the total scale and 0.89 to 0.91 for the subscales (Ada, 2025). In the present study, Cronbach's alpha was 0.89.
Intervention Theoretical framework The programme was based on Beck's (2015) middle range theory of traumatic childbirth, which describes the long-term consequences of traumatic birth for women, the mother-infant relationship, partners and the healthcare professionals present. Beck identifies loss of control, lack of respect and inadequate communication as central to traumatic childbirth and emphasises prevention. Accordingly, the programme aimed to help women anticipate situations they might encounter during labour and birth, manage their expectations, strengthen their sense of control and identify sources of support. Online delivery was chosen to improve access by enabling women to participate without attending a physical venue.
Educational content The programme covered three main areas: (1) female reproductive anatomy, the menstrual cycle, fertilisation and the physiological, systemic and psychological changes of pregnancy; (2) health in pregnancy, including common symptoms and their management, nutrition and fluid intake, smoking and alcohol use, sexual life, exercise, antenatal care and danger signs; and (3) preparation for birth, including the psychology of childbirth, the stages and process of labour, pushing techniques, non-pharmacological pain relief methods and atraumatic birth. Content on labour, pain relief and atraumatic birth was intended to help women anticipate what might happen during birth and strengthen their sense of control, in line with Beck's framework.
Development and review of the educational materials The educational content was independently reviewed by 13 experts in midwifery and obstetric and gynaecological nursing. The DISCERN instrument and the Evaluation of the Suitability of Written Materials form were used to assess the quality and suitability of the materials.
DISCERN instrument: DISCERN was developed by Charnock et al. (1999) to assess the quality of written consumer health information about treatment choices. The original instrument comprises 16 items organised into three sections addressing reliability, the quality of information about treatment choices and overall quality. In the present study, assessment was based on the first 15 items. Each item was rated on a five-point scale, with 1 indicating 'no', 3 'partially' and 5 'yes'. Item scores were summed to give a total ranging from 15 to 75, with higher scores indicating better information quality. The mean total score awarded by the 13 experts was 69.77 (1.74) out of a possible 75.
Evaluation of the Suitability of Written Materials form: The suitability of the materials was assessed using the 27-item Evaluation of the Suitability of Written Materials form, originally based on Doak et al. (1996) and adapted into Turkish by Demir et al. (2008). The form comprises six sections covering content, literacy demands, pictures and graphics, layout and typography, learning and motivation, and cultural appropriateness. Responses were scored as 1 for 'yes' and 0 for 'no', except for the negatively worded items 18, 20, 21 and 22, which were reverse-scored. Item scores were summed to give a total ranging from 0 to 27, with higher scores indicating greater suitability. The mean total score awarded by the 13 experts was 24.92 (0.95) out of a possible 27.
Intervention delivery Women in both groups were contacted via WhatsApp to arrange the sessions and data collection. The intervention was delivered by the first author, a midwife and academic with clinical experience in labour and birth care. Sessions were held via Zoom in groups of four, with each group scheduled on a different day. Each session comprised 45 minutes of education, a 15-minute break and a 45-minute question-and-answer session. Teaching methods included verbal explanation, discussion, slide presentations and questions and answers, which were used to encourage active participation and give women opportunities to discuss their concerns. All 32 women in the intervention group who were included in the analysis completed the educational session. Gestational age was not an eligibility criterion and therefore varied among participants. After the study was completed, women in the control group were given an information booklet covering the topics of the education so that they would not be deprived of the information.
Pretesting of the participant characteristics form Sample size recommendations for pilot studies vary, and the number of participants should be guided by the purpose of the preliminary assessment (In, 2017). In the present study, the participant characteristics form was pretested with 20 pregnant women attending the outpatient clinic to assess whether the questions were understandable. The women reported that the form was clear, and no changes were made following pretesting. Women who participated in pretesting were not included in either the intervention or control group.
Data collection After the necessary approvals had been obtained, the head of the obstetrics outpatient clinic at XXX Maternity and Children's Hospital and the midwives and nurses working there were informed about the purpose and scope of the study. The study was explained to pregnant women waiting for their outpatient appointments, and verbal and written informed consent was obtained from those who agreed to participate. Women then completed the participant characteristics form, the TCPS and the eHEALS-PW face to face at the clinic; this served as both the eligibility screening and the baseline assessment. Women who scored at least 53 on the TCPS and met the other eligibility criteria were randomised as described above.
TCPS scores were collected at three time points: baseline, immediately after the session (post-test) and one month after the post-test (follow-up). The participant characteristics form and the eHEALS-PW were administered at baseline only. All educational sessions were completed within a one-month period, and post-test and follow-up assessments were completed online. Women in the control group, who received routine antenatal care only, completed the assessments at corresponding time points scheduled according to the session dates of the intervention groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: educationWomen in both groups were contacted via WhatsApp to arrange the sessions and data collection. The intervention was delivered by the first author, a midwife and academic with clinical experience in labour and birth care. Sessions were held via Zoom in groups of four, with each group scheduled on a different day. Each session comprised 45 minutes of education, a 15-minute break and a 45-minute question-and-answer session. Teaching methods included verbal explanation, discussion, slide presentations and questions and answers, which were used to encourage active participation and give women opportunities to discuss their concerns. All 32 women in the intervention group who were included in the analysis completed the educational session. Gestational age was not an eligibility criterion and therefore varied among participants. |
| control | No intervention | –No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
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 |
|---|---|---|
| educationAll educational sessions were completed within a one-month period, and post-test and follow-up assessments were completed online. Women in the control group, who received routine antenatal care only, completed the assessments at corresponding time points scheduled according to the session dates of the intervention groups. | Other | Experimental group |
Primary outcome
pre-test post-test
Time frame: 1 month
The traumatic Childbirth Perception scale in pregnant women will be used as a pre-test and post-test. The experimental and control groups of the study will consist of pregnant women who scored at least 53 points on the Traumatic Childbirth Perception Scale. The minimum traumatic birth perception scale score is 0, and the maximum is 130. Scale total score 0-26 points range is very low, 27-52 points range is low, 53-78 points range is medium, 79-104 points range is high, and 105-130 points range is very high traumatic birth perception level.
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Güleser ADA, Master study chair
sakarya üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Pregnant Women and Education, run by Sakarya 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 Oct 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?
pre-test post-test (time frame: 1 month). 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 Oct 2026.