Virtual Reality Birth Simulator (ViVaDeX)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Education; Virtual Reality; Simulation Training; Normal Vaginal Delivery
• Intervention / Treatment: Other: Mannequin-based simulator; Other: Virtual reality simulator

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arundhati Gosavi, MBBS, DGO, MRCOG; Phone Number: 656-772-5555; Email: arundhati_gosavi@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Yong Loo Lin School of Medicine, National University of Singapore
    • Contact: Arundhati Gosavi, MBBS, DGO, MRCOG; Phone Number: 656-772-5555; Email: arundhati_gosavi@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Declined to give consent or to have simulation videotaped

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mannequin-based simulator; Legacy PROMPT Flex® mannequin	Other: Mannequin-based simulator; Legacy PROMPT Flex® mannequin
Active Comparator: Virtual-reality simulator; 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: Virtual reality simulator; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage improvement in knowledge scores	Percentage of a knowledge quiz answered correctly before and after exposure to the first simulation device	The time frame of involvement for each participant is 4 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean scores from the feedback questionnaire	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".	The time frame of involvement for each participant is 4 hours.

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Medical education; Obstetrics; Labour; Vaginal delivery; Simulation training
• Other Study ID Numbers: NUS-IRB-2020-606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Percentage correct from the knowledge questionanire, type of questionnaire and the constituents.
• IPD Sharing Time Frame: 8th July 2022 to 30th Jul 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No