NCT06718673

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

December 1, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

PregnancyNormal BirthBirth AdaptationNormal Birth Tendency.Virtual RealityMidwiferyDelivery room

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    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

    3 months

Study Arms (2)

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.

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.

Other: standart of care

Interventions

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)

virtual delivery room visit

Pregnant women in the control group did not receive any intervention other than routine care and counselling.

Standard of care

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate in the research.
  • Multiparous pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Centre, 78050, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, it was not possible to blind participants or care providers.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 5, 2024

Study Start

July 1, 2022

Primary Completion

September 15, 2023

Study Completion

November 1, 2023

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations