Virtual Reality Birth Simulator

NCT ID: NCT06653270

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2025-07-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Mannequin-based simulator

Legacy PROMPT Flex® mannequin

Group Type: ACTIVE_COMPARATOR

Mannequin-based simulator

Intervention Type: OTHER

Legacy PROMPT Flex® mannequin

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

Group Type: ACTIVE_COMPARATOR

Virtual reality simulator

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Mannequin-based simulator

Legacy PROMPT Flex® mannequin

Intervention Type: OTHER

Other Intervention Names

ViVaDex

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Declined to give consent or to have simulation videotaped

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yong Loo Lin School of Medicine, National University of Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Arundhati Gosavi, MBBS, DGO, MRCOG

Role: CONTACT

arundhati_gosavi@nuhs.edu.sg

656-772-5555

Facility Contacts

Arundhati Gosavi, MBBS, DGO, MRCOG

Role: primary

arundhati_gosavi@nuhs.edu.sg

656-772-5555

Other Identifiers

NUS-IRB-2020-606

Identifier Type: -

Identifier Source: org_study_id