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Not yet recruiting NCT07161141

Developing an Immersive Virtual Reality Platform

No phase Interventional Pregnancy Mental Health (Depression) Childbirth Preparation Program

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing.
Who it may be relevant to
Registry conditions: Pregnancy, Mental Health (Depression), Childbirth Preparation Program. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 a

Primary outcome measures

  • Childbirth Self-Efficacy Scale - Short Form [Time frame: 4 weeks]
  • Childbirth Self-Efficacy Scale - Short Form [Time frame: From enrollment to the end of the intervention at 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07161141 · 03072025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗