Developing an Immersive Virtual Reality Platform (VR Support)

September 15, 2025 updated by: Vesile Koak, Necmettin Erbakan University

Developing an Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing in Pregnant Women

This study is a two-stage, mixed-method, pre-test post-test design aimed at developing and testing an immersive VR intervention for new mothers. This research is 2-arm a 4-week prospective randomized clinical trial

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an intervention-based study. The first phase of the research will focus on developing the intervention, which will involve the creation of a virtual labyrinth. The concept of "Labyrinth of Birth," was popularized by Pam England. This approach uses the labyrinth as a metaphor to represent the emotional and psychological journey of labor and childbirth. In this model, the mother mentally "walks" through a labyrinth, symbolizing the unique challenges, introspections, and transformations of labor (England, 1998). In this study, the period from pregnancy to birth will be represented as a labyrinth walk with the education, self awarness and motivation content. The content will focus on how to best prepare the mothers during this journey. The content will be revised and finalized based on expert feedback panel, including academics with expertise in pregnancy, childbirth, mental health, VR, until it is deemed appropriate. Then the content will be transferred to a the VR environment. An expert team will be assembled to design the digital labyrinth, and it will be made accessible through VR HMDs. The second phase of the study will focus on testing the intervention.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The pregnant women between the ages of 18-49
  • Primiparous
  • At least 20 weeks of gestation
  • Single pregnancy
  • Without any visual and hearing problems andcan communicate verbally are included to this study.

Exclusion Criteria:

  • Pregnant women with multiple pregnancies were multiparous
  • Risky pregnancy, and did not accept participation in the study will excluded from the study.
  • Individuals with a history of any psychiatric disorder (eg, mood disorder or anxiety disorder) will excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experiment
According to international guidelines (e.g., WHO, ACOG, APA), consistent and frequent antenatal care contacts are recommended throughout pregnancy. While a specific number of sessions is not always defined, these guidelines emphasize the importance of providing information within the framework of birth preparedness and complication readiness during these visits. Furthermore, childbirth education programs are encouraged to incorporate psychoeducation and mindfulness-based approaches to support maternal psychological well-being and informed decision-making. In the systematic review, all included studies showed positive effects of the VR and gamification interventions used, regardless of the frequency, intensity, or duration of the intervention (Jingili et al., 2023). VR program will be implemented three times between 20-36 week. Each session will last approximately 10-20 minutes.
Device: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing

The VR-based intervention will be grounded in a childbirth education framework designed to enhance women's awareness of their attitudes toward childbirth, their readiness for the birthing process, and their expectations related to labor, delivery, and the postpartum period. The program aims to strengthen emotional insight and coping capacities by guiding participants to reflect on their feelings and thoughts throughout the childbirth journey. The intervention will integrate key components such as breath awareness exercises, coping techniques, and motivational messages. While participants receive structured childbirth education, they will simultaneously be supported in developing psychological preparedness through immersive and reflective experiences tailored to foster emotional resilience and self-efficacy.

The digital labyrinth will be designed both visually and functionally to facilitate immersive navigation. It will be set in an expansive virtual landscape enriched with natural elem
No Intervention: Control
The control group will receive only routine antenatal care, and will complete the pre-test and post-test questionnaires without participating in the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth Self-Efficacy Scale - Short Form
Time Frame: 4 weeks
Designed by Lowe in 1993 (Lowe, 1993)to measure the selfconfidence and coping skills of women, CBSEI, consisting of 62 items, was reduced to 32 items by Ip, Chung and Tang in 2008 (Ip et al., 2008). Outcome Expectancy (OE): 16 items evaluating the belief that specific behaviors will lead to desired outcomes during childbirth. The questions in the 10 point Likert type scale are scored between 1 and 10. The scale consists of two subdimensions, each containing 16 questions: "Result Expectation" and "Efficacy Expectation". Self-Efficacy Expectancy (EE): 16 items assessing the confidence in one's ability to perform those behaviors effectively. Scoring: Each item is rated on a 10-point Likert scale, with higher scores indicating greater self-efficacy. The CBSEI scales have excellent internal consistency reliability (.86 to .96)
4 weeks
Childbirth Self-Efficacy Scale - Short Form
Time Frame: From enrollment to the end of the intervention at 4 weeks
Designed by Lowe in 1993 (Lowe, 1993)to measure the selfconfidence and coping skills of women, CBSEI, consisting of 62 items, was reduced to 32 items by Ip, Chung and Tang in 2008 (Ip et al., 2008). Outcome Expectancy (OE): 16 items evaluating the belief that specific behaviors will lead to desired outcomes during childbirth. The questions in the 10 point Likert type scale are scored between 1 and 10. The scale consists of two subdimensions, each containing 16 questions: "Result Expectation" and "Efficacy Expectation". Self-Efficacy Expectancy (EE): 16 items assessing the confidence in one's ability to perform those behaviors effectively. Scoring: Each item is rated on a 10-point Likert scale, with higher scores indicating greater self-efficacy. The CBSEI scales have excellent internal consistency reliability (.86 to .96)
From enrollment to the end of the intervention at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

August 7, 2025

First Submitted That Met QC Criteria

September 3, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03072025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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