PregnancyEVDRVBBANCT06718673
The Effect of Virtual Delivery Room Visit on Birth Belief and Adaptation
A study testing virtual delivery room visit and standart of care in people with Pregnancy and Birth, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Aims: The aim is to examine the effect of virtual delivery room visits on primiparous women's beliefs about normal birth and their birth adaptation. Method: A prospective, randomized controlled study was conducted between July and November 2023 at a training hospital in the Western Black Sea Region of Türkiye. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Birth, Delivery Room
- What is being tested?
- virtual delivery room visit and standart of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Nov 2023
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being a primiparous pregnant woman.
- Being between 24 and 40 weeks of gestation.
- Having no pregnancy-related risk factors.
- Not having visited the delivery room of the hospital where the study was conducted prior to the study.
- Planning to give birth at the same hospital.
- Spending at least three hours in labor during childbirth.
- Having access to an internet-connected device.
Who cannot join
- Refusal to participate in the research.
- Multiparous pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Delivery Room Visits on Primiparous Women's Beliefs About Normal Birth and Their Birth Adaptation
Aims: The aim is to examine the effect of virtual delivery room visits on primiparous women's beliefs about normal birth and their birth adaptation.
Method: A prospective, randomized controlled study was conducted between July and November 2023 at a training hospital in the Western Black Sea Region of Türkiye. Eighty pregnant women were randomly assigned to the intervention (n=40) and control (n=40) groups. Pre-test data were collected using the Participant Information Form and the Belief Scale for Normal Delivery(BSND), and post-test data were collected with BSND after the virtual delivery room visit. The Birth Adaptation Self-Assessment Scale(BASAS) and Birth Adaptation Midwife Assessment Scale(BAMAS) were administered to the intervention group.
Read the detailed description
One of the important factors of fear of birth is the uncertainty of pregnant women about the birth environment. Especially primiparous women experience intense fear and anxiety due to insufficient information about the birth process and environment. This situation may negatively affect their birth experience by increasing their level of fear before birth. Birth adaptation refers to a woman's ability to physically and emotionally interact with her environment in a healthy way during the birth process. This adaptation is made possible by women's healthy behaviours and effective cooperation with the healthcare team. This interaction, which is necessary for a positive birth experience, makes women feel safe and contributes to making the birth process more manageable. In this context, in order to prevent uncertainties about the birth process from negatively affecting birth adaptation, it is important for women to recognise the delivery room, to be adequately informed about the birth process and to provide a reassuring environment. These factors enable women to prepare for the birth process more effectively, increase their confidence in the healthcare team and themselves, and make both the physical and emotional dimensions of birth more manageable.
The best way to prepare effectively for the birth process is to participate in antenatal education programmes. These programmes reduce uncertainty by encouraging pregnant women to learn about the birth process and provide an opportunity to familiarise themselves with the delivery room. Women's knowledge of the birth process facilitates healthy behaviour and effective collaboration with health care staff. This process enables women to participate more effectively in the birth process and contributes to their confidence in themselves and the health care team. In addition, antenatal education helps to prevent unnecessary caesarean sections by strengthening beliefs in normal birth.
Improving the quality and accessibility of antenatal education will make a significant contribution to reducing the high cesarean section rates worldwide. In many countries such as Turkey, caesarean section rates are far above the ideal levels (10-15%) set by the World Health Organisation. These high rates carry serious risks for maternal health and it is an urgent necessity to solve this problem. In this context, qualitative and quantitative improvement of antenatal education will be an important step in reducing caesarean section rates.
Time constraints, transport difficulties, inadequacy of trainings and financial barriers are among the main factors preventing regular participation of pregnant women in antenatal education. The COVID-19 pandemic has increased difficulties in accessing healthcare services, leading to the suspension of face-to-face trainings, which has negatively affected pregnant women's preparation for the birth process. Digital trainings help to overcome these barriers, enabling pregnant women to prepare for labour more effectively. In addition, widespread internet access and the demand for reliable information provide a favourable environment for the development of low-cost and widely accessible applications.
The aim of this study was to examine the effect of virtual delivery room visit on primiparous pregnant women's beliefs about normal birth and birth adjustment. The virtual delivery room visit aims to increase birth adjustment and develop positive beliefs towards normal birth by providing pregnant women with the opportunity to get to know the delivery room.
H0 : Virtual delivery room visits have no effect on primiparous women's beliefs about normal birth and their birth adaptation H1a: Virtual delivery room visits increase primiparous women's levels of belief in normal birth.
H1b: Primiparous women who perform a virtual delivery room visit have higher levels of birth adaptation from their own perspective compared to those who do not perform the visit.
H1c: Primiparous women who perform a virtual delivery room visit have higher levels of birth adaptation from their midwives' perspective compared to those who do not perform the visit.
H1d: There is a relationship between primiparous women's beliefs about normal birth and their birth adaptation.
- Conditions
- Pregnancy, Birth, Delivery Room, Midwifery, Virtual Reality, Adaptation
- Being tested
- virtual delivery room visit, standart of care
- Keywords
- Pregnancy, Normal Birth, Birth Adaptation, Normal Birth Tendency., Virtual Reality, Midwifery, Delivery room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual delivery room visitOther
The real-time labour room demonstration video aims to increase participants' awareness of the labour process, reduce unfamiliarity, and facilitate participation for pregnant women with access restrictions. Produced with a 360-degree camera, it shows detailed sections of the labour room, starting from the entrance. Key areas like birthing beds, toilets, bathrooms, and labour materials (mats, pilates balls, TVs) are highlighted. The video also covers baby cots and rest areas for attendants. Narrated by an experienced midwife, the video ensures patient privacy, no interventions, and excludes images or sounds of other pregnant women. Converted to 360-degree format, the video is available on YouTube for repeated viewing. (https://www.youtube.com/watch?v=EyCt-jTDCVs)
standart of careOther
Pregnant women in the control group did not receive any intervention other than routine care and counselling.
| Study group | Role | What they receive |
|---|---|---|
| virtual delivery room visit | Experimental | Participants were informed about the study, the Participant Information Form was provided during the initial interview, and the Belief Scale for Normal Delivery pre-test was administered. Following, participants in the intervention group were provided with a link to a virtual delivery room introduction video (https://www.youtube.com/watch?v=EyCt-jTDCVs), created using the actual delivery room environment, and were encouraged to watch it., a second interview was conducted four days after the initial interview, during which post-test data were collected using the Belief Scale for Normal Delivery form. After all participants completed their birth processes, a third interview was conducted, and the data collection process was finalized using the Birth Adaptation Self-Assessment Scale and Birth Adaptation Midwife Assessment Scale forms. Receives: Other: virtual delivery room visit |
| Standard of care | Other | Participants were informed about the study, the Participant Information Form was provided during the initial interview, and the Belief Scale for Normal Delivery pre-test was administered. However, no intervention related to the virtual delivery room visit was conducted with the control group. This group was only subjected to a monitoring process after the pre-test. Four days after the initial interview, a second interview was conducted with participants in the control group, during which post-test data were collected using the BSND form. After the birth processes of the participants in the control group were completed, a third interview was conducted, and the data collection process was completed using the Birth Adaptation Self-Assessment Scale and Birth Adaptation Midwife Assessment Scale forms. Receives: Other: standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Belief Scale for Normal Delivery (BSND)
assesses pregnant women's beliefs about normal birth. It includes 24 items rated on a five-point Likert scale (1-5), with reverse scoring for the perceived barriers subscale (items 12-17). Scores range from 24 to 120, categorized as low (24-56), medium (57-88), or high (89-120).
Measured: 3 months
Birth Adaptation Self-Assessment Scale (BASAS)
Birth Adaptation Self-Assessment Scale, self-assesses a pregnant woman's birth adaptation from her own perspective. The scale contains two subdimensions and a total of 22 items. The two subdimensions are "Midwife-Pregnant Woman Relationship Adaptation" and "Birth Environment Adaptation." Scoring uses a five-point Likert scale, with 1 representing "Strongly Disagree" and 5 representing "Strongly Agree." Item 11 in the "Midwife-Pregnant Woman Relationship Adaptation" subdimension is reverse-scored; there are no reverse-scored items in the "Birth Environment Adaptation" subdimension.
Measured: 3 months
Birth Adaptation Midwife Assessment Scale
Birth Adaptation Midwife Assessment Scale, evaluates whether pregnant women are adapted during their birth processes from the perspective of the midwife who attended the birth. The scale consists of a single subdimension with 17 items. Scoring uses a five-point Likert scale, with 1 representing "Strongly Disagree" and 5 representing "Strongly Agree." Item 8 is reverse-scored.
Measured: 3 months
Participant Information Form
The form collected socio-demographic information such as age, education level, income status, and obstetric characteristics, including the number of pregnancies, number of live births, the desire for the current pregnancy, and information related to pregnancy and birth. The questionnaire comprised a total of 21 questions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jul 2022
- Primary completion15 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKINCI, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718673
- Sponsor's protocol ID
- E-25403353-050.99-294113
- Acronym
- EVDRVBBA
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Delivery Room Visits on Primiparous Women's Beliefs About Normal Birth and Their Birth Adaptation
- ClinicalTrials.gov ID
- NCT06718673
- Acronym / sponsor ID
- EVDRVBBA / E-25403353-050.99-294113
- Conditions
- Pregnancy, Birth, Delivery Room, Midwifery, Virtual Reality, Adaptation
- Keywords
- Pregnancy, Normal Birth, Birth Adaptation, Normal Birth Tendency., Virtual Reality, Midwifery, Delivery room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Dec 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.
Aims: The aim is to examine the effect of virtual delivery room visits on primiparous women's beliefs about normal birth and their birth adaptation.
Method: A prospective, randomized controlled study was conducted between July and November 2023 at a training hospital in the Western Black Sea Region of Türkiye. Eighty pregnant women were randomly assigned to the intervention (n=40) and control (n=40) groups. Pre-test data were collected using the Participant Information Form and the Belief Scale for Normal Delivery(BSND), and post-test data were collected with BSND after the virtual delivery room visit. The Birth Adaptation Self-Assessment Scale(BASAS) and Birth Adaptation Midwife Assessment Scale(BAMAS) were administered to the intervention group.
Detailed description
One of the important factors of fear of birth is the uncertainty of pregnant women about the birth environment. Especially primiparous women experience intense fear and anxiety due to insufficient information about the birth process and environment. This situation may negatively affect their birth experience by increasing their level of fear before birth. Birth adaptation refers to a woman's ability to physically and emotionally interact with her environment in a healthy way during the birth process. This adaptation is made possible by women's healthy behaviours and effective cooperation with the healthcare team. This interaction, which is necessary for a positive birth experience, makes women feel safe and contributes to making the birth process more manageable. In this context, in order to prevent uncertainties about the birth process from negatively affecting birth adaptation, it is important for women to recognise the delivery room, to be adequately informed about the birth process and to provide a reassuring environment. These factors enable women to prepare for the birth process more effectively, increase their confidence in the healthcare team and themselves, and make both the physical and emotional dimensions of birth more manageable.
The best way to prepare effectively for the birth process is to participate in antenatal education programmes. These programmes reduce uncertainty by encouraging pregnant women to learn about the birth process and provide an opportunity to familiarise themselves with the delivery room. Women's knowledge of the birth process facilitates healthy behaviour and effective collaboration with health care staff. This process enables women to participate more effectively in the birth process and contributes to their confidence in themselves and the health care team. In addition, antenatal education helps to prevent unnecessary caesarean sections by strengthening beliefs in normal birth.
Improving the quality and accessibility of antenatal education will make a significant contribution to reducing the high cesarean section rates worldwide. In many countries such as Turkey, caesarean section rates are far above the ideal levels (10-15%) set by the World Health Organisation. These high rates carry serious risks for maternal health and it is an urgent necessity to solve this problem. In this context, qualitative and quantitative improvement of antenatal education will be an important step in reducing caesarean section rates.
Time constraints, transport difficulties, inadequacy of trainings and financial barriers are among the main factors preventing regular participation of pregnant women in antenatal education. The COVID-19 pandemic has increased difficulties in accessing healthcare services, leading to the suspension of face-to-face trainings, which has negatively affected pregnant women's preparation for the birth process. Digital trainings help to overcome these barriers, enabling pregnant women to prepare for labour more effectively. In addition, widespread internet access and the demand for reliable information provide a favourable environment for the development of low-cost and widely accessible applications.
The aim of this study was to examine the effect of virtual delivery room visit on primiparous pregnant women's beliefs about normal birth and birth adjustment. The virtual delivery room visit aims to increase birth adjustment and develop positive beliefs towards normal birth by providing pregnant women with the opportunity to get to know the delivery room.
H0 : Virtual delivery room visits have no effect on primiparous women's beliefs about normal birth and their birth adaptation H1a: Virtual delivery room visits increase primiparous women's levels of belief in normal birth.
H1b: Primiparous women who perform a virtual delivery room visit have higher levels of birth adaptation from their own perspective compared to those who do not perform the visit.
H1c: Primiparous women who perform a virtual delivery room visit have higher levels of birth adaptation from their midwives' perspective compared to those who do not perform the visit.
H1d: There is a relationship between primiparous women's beliefs about normal birth and their birth adaptation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual delivery room visit | Experimental | Other: virtual delivery room visitParticipants were informed about the study, the Participant Information Form was provided during the initial interview, and the Belief Scale for Normal Delivery pre-test was administered. Following, participants in the intervention group were provided with a link to a virtual delivery room introduction video (https://www.youtube.com/watch?v=EyCt-jTDCVs), created using the actual delivery room environment, and were encouraged to watch it., a second interview was conducted four days after the initial interview, during which post-test data were collected using the Belief Scale for Normal Delivery form. After all participants completed their birth processes, a third interview was conducted, and the data collection process was finalized using the Birth Adaptation Self-Assessment Scale and Birth Adaptation Midwife Assessment Scale forms. |
| Standard of care | Other | Other: standart of careParticipants were informed about the study, the Participant Information Form was provided during the initial interview, and the Belief Scale for Normal Delivery pre-test was administered. However, no intervention related to the virtual delivery room visit was conducted with the control group. This group was only subjected to a monitoring process after the pre-test. Four days after the initial interview, a second interview was conducted with participants in the control group, during which post-test data were collected using the BSND form. After the birth processes of the participants in the control group were completed, a third interview was conducted, and the data collection process was completed using the Birth Adaptation Self-Assessment Scale and Birth Adaptation Midwife Assessment Scale forms. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Being a primiparous pregnant woman.
- Being between 24 and 40 weeks of gestation.
- Having no pregnancy-related risk factors.
- Not having visited the delivery room of the hospital where the study was conducted prior to the study.
- Planning to give birth at the same hospital.
Key exclusion criteria (2 listed)
- Refusal to participate in the research.
- Multiparous pregnancy.
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 |
|---|---|---|
| virtual delivery room visitThe real-time labour room demonstration video aims to increase participants' awareness of the labour process, reduce unfamiliarity, and facilitate participation for pregnant women with access restrictions. Produced with a 360-degree camera, it shows detailed sections of the labour room, starting from the entrance. Key areas like birthing beds, toilets, bathrooms, and labour materials (mats, pilates balls, TVs) are highlighted. The video also covers baby cots and rest areas for attendants. Narrated by an experienced midwife, the video ensures patient privacy, no interventions, and excludes images or sounds of other pregnant women. Converted to 360-degree format, the video is available on YouTube for repeated viewing. (https://www.youtube.com/watch?v=EyCt-jTDCVs) | Other | virtual delivery room visit |
| standart of carePregnant women in the control group did not receive any intervention other than routine care and counselling. | Other | Standard of care |
Primary outcome
Belief Scale for Normal Delivery (BSND)
Time frame: 3 months
assesses pregnant women's beliefs about normal birth. It includes 24 items rated on a five-point Likert scale (1-5), with reverse scoring for the perceived barriers subscale (items 12-17). Scores range from 24 to 120, categorized as low (24-56), medium (57-88), or high (89-120).
Birth Adaptation Self-Assessment Scale (BASAS)
Time frame: 3 months
Birth Adaptation Self-Assessment Scale, self-assesses a pregnant woman's birth adaptation from her own perspective. The scale contains two subdimensions and a total of 22 items. The two subdimensions are "Midwife-Pregnant Woman Relationship Adaptation" and "Birth Environment Adaptation." Scoring uses a five-point Likert scale, with 1 representing "Strongly Disagree" and 5 representing "Strongly Agree." Item 11 in the "Midwife-Pregnant Woman Relationship Adaptation" subdimension is reverse-scored; there are no reverse-scored items in the "Birth Environment Adaptation" subdimension.
Birth Adaptation Midwife Assessment Scale
Time frame: 3 months
Birth Adaptation Midwife Assessment Scale, evaluates whether pregnant women are adapted during their birth processes from the perspective of the midwife who attended the birth. The scale consists of a single subdimension with 17 items. Scoring uses a five-point Likert scale, with 1 representing "Strongly Disagree" and 5 representing "Strongly Agree." Item 8 is reverse-scored.
Participant Information Form
Time frame: 3 months
The form collected socio-demographic information such as age, education level, income status, and obstetric characteristics, including the number of pregnancies, number of live births, the desire for the current pregnancy, and information related to pregnancy and birth. The questionnaire comprised a total of 21 questions
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 12 Dec 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.
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 virtual delivery room visit and standart of care in people with Pregnancy and Birth, run by Karabuk 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 7 inclusion and 2 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 12 Dec 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?
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?
Belief Scale for Normal Delivery (BSND) (time frame: 3 months). 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 12 Dec 2024.