Developing an Immersive Virtual Reality… | Clinical Trial

Key information

Conditions

Pregnancy Behavior Behavioral Symptoms Childbirth Preparation Program Depression Mental Health (Depression) Personal Satisfaction Psychological Well-Being

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing

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

Primary outcomes

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)
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)

Study contacts

Contact information is provided by the study sponsor or research team.

Vesile KOÇAK

CONTACT

[email protected]

+905073300997

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Acronym: VR Support

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Sep 8, 2025
Registry last updated: Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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