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NCT Number: NCT06653270

Virtual Reality Birth Simulator

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yong Loo Lin School of Medicine, National University of Singapore

Singapore

Location status: Recruiting

Location contact

Arundhati Gosavi, MBBS, DGO, MRCOG

CONTACT

[email protected]

656-772-5555

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Declined to give consent or to have simulation videotaped

Treatment and study plan

Virtual reality simulator

Other

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

Other names: ViVaDex

Mannequin-based simulator

Other

Legacy PROMPT Flex® mannequin

Primary outcomes

  1. Percentage improvement in knowledge scores

    Time frame: The 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 outcomes

  1. Mean scores from the feedback questionnaire

    Time frame: The 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".

Study contacts

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

Arundhati Gosavi, MBBS, DGO, MRCOG

CONTACT

[email protected]

656-772-5555

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Acronym: ViVaDeX

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

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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