Developing an Immersive Virtual Reality Platform

NCT ID: NCT07161141

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-30

Brief Summary

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

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.

Conditions

Pregnancy; Mental Health (Depression); Childbirth Preparation Program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Vesile Koak

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vesile KOÇAK

Role: CONTACT

vesilekck@gmail.com

+905073300997

Other Identifiers

03072025

Identifier Type: -

Identifier Source: org_study_id