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Virtual Reality Birth Simulator

Virtual Reality Simulation Training for Childbirth- a Cluster Randomised Crossover Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06653270
Acronym
ViVaDeX
Enrollment
300
Registered
2024-10-22
Start date
2022-07-08
Completion date
2025-07-30
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Education, Normal Vaginal Delivery, Simulation Training, Virtual Reality

Keywords

Obstetrics, Labour, Vaginal delivery, Simulation training, Medical education

Brief summary

The investigators compared an in-house developed virtual reality simulator for normal vaginal deliveries with a legacy mannequin-based simulation in a cluster randomised study involving Year 4 medical students undergoing their Ob/Gyn clerkship with aims to compare pre- and post-simulation knowledge questionnaire score. As part of a cross-over component, the investigators will also compare feedback scores for each modality and the preferred modality. Ethical approval and waiver of consent has been obtained from the National University of Singapore Institutional Review Board, Reference Number 2020-606.

Detailed description

Simulations training is an important aspect of procedural skills training. This is especially so for normal vaginal deliveries given its intimate and time sensitive nature. Medical students have to also compete with limited learning opportunities against other healthcare trainees in the labour ward. Thus, the need for simulation training has been extensively used in this area. Nevertheless, mannequin-based simulations are also limited in availability due to the need for expensive mannequins, skilled trainers, and suitable venues. The investigators developed a virtual reality normal vaginal delivery simulation (ViVaDex) based on the Oculus® Quest 2 retail Head Mounted Display and aim to compare this against legacy mannequin-based methods (PROMPT Flex®) via a a cluster randomised study involving Year 4 medical students undergoing their Obstetrics and Gynecology clerkship. The investigators would compare percentage correct scores pre- and post-simulation through an 11-item knowledge questionnaires and also conduct a six-domain feedback questionnaire. Due to a planned cross-over component, participants will be able to also state their preferred simulation modality. Ethical approval and waiver of consent has been obtained from the National University of Singapore Institutional Review Board, Reference Number 2020-606. Our statistical plan is to use two sample t-test to compare the improvement in pre- and post-simulation percentage correct scores between each modality and chi square testing to assess differences in the proportion who got each question correct. The feedback questionnaire scores will be compared between the VR and mannequin modalities using linear mixed modelling with teaching modality, period, and group being designated as main effects and presented as mean total feasibility scores with differences presented as adjusted mean difference with 95th centile confidence intervals (95% CI). Carryover effect will also be calculated as this is a cross-over study.

Interventions

A in-house developed immersive virtual simulation of a normal vaginal delivery developed using a Unity Engine and installed in Oculus® Quest 2 head-mounted device

OTHERMannequin-based simulator

Legacy PROMPT Flex® mannequin

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Medical students undergoing their 4th year obstetrics and gynaecology clerkship

Exclusion criteria

* Declined to give consent or to have simulation videotaped

Design outcomes

Primary

MeasureTime frameDescription
Percentage improvement in knowledge scoresThe time frame of involvement for each participant is 4 hours.Percentage of a knowledge quiz answered correctly before and after exposure to the first simulation device

Secondary

MeasureTime frameDescription
Mean scores from the feedback questionnaireThe time frame of involvement for each participant is 4 hours.Participants answered a Ffeedback Questionnaire after each simulation. A score was calculated based on this feedback. This feedback questionnaire 6 domain questionnaire comprising a mix of 14 positively- and negatively-framed questions that were scaled on a 5-point Likert scale with 1 indicating strongly disagree and 5 indicating strongly agree.

Countries

Singapore

Contacts

Primary ContactArundhati Gosavi, MBBS, DGO, MRCOG
arundhati_gosavi@nuhs.edu.sg656-772-5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026