Developing an Immersive Virtual Reality Platform (VR Support)

Necmettin Erbakan University

Status: Not yet enrolling

Conditions: Childbirth Preparation Program; Mental Health (Depression); Pregnancy

Treatments: Device: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing

Study type: Interventional

Funder types: Other

Identifiers

NCT07161141

03072025

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Experiment

Experimental group

Description:

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.

Treatment:

Device: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing

Control

No Intervention group

Description:

The control group will receive only routine antenatal care, and will complete the pre-test and post-test questionnaires without participating in the intervention.