Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653270
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Virtual Reality Birth Simulator
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality Simulation Training for Childbirth- a Cluster Randomised Crossover Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViVaDeX
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 ObGyn 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None