Healthy VolunteersNCT06196151
The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception
A study testing Antenatal training in people with Healthy Volunteers and Pregnancy Trimester, Second, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pregnancy Trimester, Second, Pregnancy Trimester, Third
- What is being tested?
- Antenatal training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 29 Feb 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary acceptance to participate in the research
- Being over 18 years of age
- Being at the 20th gestational week at the earliest.
- Not carrying a high risk in pregnancy
- Nulliparity
- Expected to have a normal spontaneous labour
Who cannot join
- Refusal to participate in the research
- Failure to complete six hours of the childbirth preparation class
- Inability to use the Zoom application
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Health Sciences
Denizli, Kınıklı, 20160
About this study
Official title: The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception: A Randomised Controlled Study
Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often lead to anxiety about the health of the baby and her own health and to the creation of new stressful situations. During antenatal education, deep relaxation and breathing techniques taught to pregnant women during labour and delivery allow the mother to relax and cope with birth pains more easily and on her own. There are not enough studies in the literature to evaluate the effectiveness of online antenatal classes. In cases where face-to-face antenatal education is not possible during pregnancy, online education is an important option. In the literature, there is no study evaluating how antenatal education affects women's fear of childbirth, physiological ability to give birth and traumatic birth perception together. Therefore, the aim of this study is to examine the effect of antenatal education on fear of childbirth, physiological ability to give birth and perception of traumatic birth. The type of the study is a randomised controlled experimental study with pre-post and control group. The research will be conducted in the form of online training meetings on pregnant women reached through social media. The population of the study will consist of healthy pregnant women who apply to the researchers as a result of the announcements made through social media and who are at the 20th gestational week at the earliest. The sample size was determined by t-test analysis in independent groups in G*power statistical programme, based on two variables, 0.05 significance level, 80% power and medium effect (0.50). Accordingly, a total of 42 pregnant women, 21 pregnant women in each group, are planned to be included in the study. Intention-to-treat analysis will be performed to prevent bias and losses. As an intervention programme, a total of three weeks and six hours of childbirth preparation training will be given, two hours each week. The programme has been prepared by faculty members who have conducted childbirth preparation classes, based on the literature and by making use of childbirth preparation philosophies and methods.
- Being tested
- Antenatal training
- Keywords
- Antenatal Education, Fear of Birth, Physiological Ability to Give Birth, Traumatic Birth Perception
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal trainingBehavioural
Training hours: Training will be completed in a total of three weeks and six hours, two hours each week.
Method: The training will be given online via Zoom application. The training will consist of a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Pregnant women in both the control and intervention groups will be asked to fill out the "Women's Introductory Information Form". The data of the intervention group will be filled out before the first Antenatal education lesson and after all six-hour Antenatal education lessons are completed. The data of the control group will be filled in parallel with the intervention group.
Group to receive the training: Healthy pregnant women who are at the 20th gestational week at the earliest will be included in the training. Trainings will be carried out in closed groups.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: Antenatal training |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form, which was developed in line with the literature, consists of 9 questions to obtain some socio-demographic characteristics and obstetric information of pregnant women.
Measured: Baseline (It will be applied before starting the intervention)
Preparation for Labor and Birth (P-LAB) Instrument
The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.
Measured: Baseline (It will be applied before starting the intervention)
Traumatic Birth Perception Scale
The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.
Measured: Baseline (It will be applied before starting the intervention)
Fear of Childbirth Scale for Pregnant Women and Their Partners
The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, \& Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.
Measured: Baseline (It will be applied before starting the intervention)
Secondary outcomes (3)
Preparation for Labor and Birth (P-LAB) Instrument
The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.
Measured: through study completion, an average of one week.
Traumatic Birth Perception Scale
The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.
Measured: through study completion, an average of one week.
Fear of Childbirth Scale for Pregnant Women and Their Partners
The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, \& Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.
Measured: through study completion, an average of one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion8 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Göral Türkcü, Assistant Prof., Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196151
- Sponsor's protocol ID
- E-60116787-020-462207
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06196151
- Acronym / sponsor ID
- E-60116787-020-462207
- Keywords
- Antenatal Education, Fear of Birth, Physiological Ability to Give Birth, Traumatic Birth Perception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 8 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 9 Jan 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.
Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often lead to anxiety about the health of the baby and her own health and to the creation of new stressful situations. During antenatal education, deep relaxation and breathing techniques taught to pregnant women during labour and delivery allow the mother to relax and cope with birth pains more easily and on her own. There are not enough studies in the literature to evaluate the effectiveness of online antenatal classes. In cases where face-to-face antenatal education is not possible during pregnancy, online education is an important option. In the literature, there is no study evaluating how antenatal education affects women's fear of childbirth, physiological ability to give birth and traumatic birth perception together. Therefore, the aim of this study is to examine the effect of antenatal education on fear of childbirth, physiological ability to give birth and perception of traumatic birth. The type of the study is a randomised controlled experimental study with pre-post and control group. The research will be conducted in the form of online training meetings on pregnant women reached through social media. The population of the study will consist of healthy pregnant women who apply to the researchers as a result of the announcements made through social media and who are at the 20th gestational week at the earliest. The sample size was determined by t-test analysis in independent groups in G*power statistical programme, based on two variables, 0.05 significance level, 80% power and medium effect (0.50). Accordingly, a total of 42 pregnant women, 21 pregnant women in each group, are planned to be included in the study. Intention-to-treat analysis will be performed to prevent bias and losses. As an intervention programme, a total of three weeks and six hours of childbirth preparation training will be given, two hours each week. The programme has been prepared by faculty members who have conducted childbirth preparation classes, based on the literature and by making use of childbirth preparation philosophies and methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Antenatal training |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary acceptance to participate in the research
- Being over 18 years of age
- Being at the 20th gestational week at the earliest.
- Not carrying a high risk in pregnancy
- Nulliparity
Key exclusion criteria (4 listed)
- Refusal to participate in the research
- Failure to complete six hours of the childbirth preparation class
- Inability to use the Zoom application
- Psychiatric illness
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 |
|---|---|---|
| Antenatal trainingTraining hours: Training will be completed in a total of three weeks and six hours, two hours each week. Method: The training will be given online via Zoom application. The training will consist of a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Pregnant women in both the control and intervention groups will be asked to fill out the "Women's Introductory Information Form". The data of the intervention group will be filled out before the first Antenatal education lesson and after all six-hour Antenatal education lessons are completed. The data of the control group will be filled in parallel with the intervention group. Group to receive the training: Healthy pregnant women who are at the 20th gestational week at the earliest will be included in the training. Trainings will be carried out in closed groups. | Behavioural | Experimental |
Primary outcome
Introductory Information Form
Time frame: Baseline (It will be applied before starting the intervention)
This form, which was developed in line with the literature, consists of 9 questions to obtain some socio-demographic characteristics and obstetric information of pregnant women.
Preparation for Labor and Birth (P-LAB) Instrument
Time frame: Baseline (It will be applied before starting the intervention)
The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.
Traumatic Birth Perception Scale
Time frame: Baseline (It will be applied before starting the intervention)
The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.
Fear of Childbirth Scale for Pregnant Women and Their Partners
Time frame: Baseline (It will be applied before starting the intervention)
The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, \& Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.
3 secondary outcomes
Preparation for Labor and Birth (P-LAB) Instrument
Time frame: through study completion, an average of one week.
Traumatic Birth Perception Scale
Time frame: through study completion, an average of one week.
Fear of Childbirth Scale for Pregnant Women and Their Partners
Time frame: through study completion, an average of one week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal training in people with Healthy Volunteers and Pregnancy Trimester, Second, run by Pamukkale 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinem Göral Türkcü, Phd, RN, Assist Prof. (05453214007, goralsinem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: Baseline (It will be applied before starting the intervention)). The study lists 4 primary outcomes in all. 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 9 Jan 2024.