NCT07161141 - Developing an Immersive Virtual Reality Platform | Crick

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

68

Conditions

Pregnancy Mental Health (Depression)Childbirth Preparation Program

Interventions

Immersive Virtual Reality Platform to Support Birth Preparedness and Mental WellbeingDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Childbirth Self-Efficacy Scale - Short Form

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)

Time frame: 4 weeks

Childbirth Self-Efficacy Scale - Short Form

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)

Time frame: From enrollment to the end of the intervention at 4 weeks

Central Contacts

Vesile KOÇAK

CONTACT

+905073300997 vesilekck@gmail.com