- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718673
The Effect of Virtual Delivery Room Visit on Birth Belief and Adaptation (EVDRVBBA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Centre
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Karabuk, Centre, Turkey, 78050
- Karabuk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal to participate in the research.
- Multiparous pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: virtual delivery room visit
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.
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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)
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Other: Standard of care
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.
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Pregnant women in the control group did not receive any intervention other than routine care and counselling.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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3 months
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Birth Adaptation Self-Assessment Scale (BASAS)
Time Frame: 3 months
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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.
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3 months
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Birth Adaptation Midwife Assessment Scale
Time Frame: 3 months
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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.
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3 months
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Participant Information Form
Time Frame: 3 months
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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
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-25403353-050.99-294113
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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