PregnancyVR SupportNCT07161141
Developing an Immersive Virtual Reality Platform
A study testing Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing in people with Pregnancy and Mental Health (Depression), run by Necmettin Erbakan University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Mental Health (Depression), Childbirth Preparation Program
- What is being tested?
- Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing an Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing in Pregnant Women
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
Read the 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.
- Being tested
- Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing
- Keywords
- Virtual reality, immersive, childbirth, mental health, pregnancy
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | 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. Receives: Device: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing |
| Control | No intervention | The control group will receive only routine antenatal care, and will complete the pre-test and post-test questionnaires without participating in the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From enrollment to the end of the intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Koak, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161141
- Sponsor's protocol ID
- 03072025
- Acronym
- VR Support
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing in Pregnant Women
- ClinicalTrials.gov ID
- NCT07161141
- Acronym / sponsor ID
- VR Support / 03072025
- Keywords
- Virtual reality, immersive, childbirth, mental health, pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Device: Immersive Virtual Reality Platform to Support Birth Preparedness and Mental WellbeingAccording 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. |
| Control | No intervention | –The control group will receive only routine antenatal care, and will complete the pre-test and post-test questionnaires without participating in the intervention. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality Platform to Support Birth Preparedness and Mental WellbeingThe 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 | Device | Experiment |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Platform to Support Birth Preparedness and Mental Wellbeing in people with Pregnancy and Mental Health (Depression), run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vesile KOÇAK (+905073300997, vesilekck@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Self-Efficacy Scale - Short Form (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.