Virtual Reality Birth Simulator

NCT06653270 | Recruiting

• 1 other identifier: NUS-IRB-2020-606
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean scores from the feedback questionnaire

  The time frame of involvement for each participant is 4 hours.

Study Arms (2)

Mannequin-based simulator

ACTIVE COMPARATOR

Legacy PROMPT Flex® mannequin

Other: Mannequin-based simulator

Virtual-reality simulator

ACTIVE COMPARATOR

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

Interventions

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

Also known as: ViVaDex

Virtual-reality simulator

Mannequin-based simulator OTHER

Legacy PROMPT Flex® mannequin

Mannequin-based simulator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Declined to give consent or to have simulation videotaped

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Yong Loo Lin School of Medicine, National University of Singapore

Singapore, Singapore

RECRUITING

Central Study Contacts

Arundhati Gosavi, MBBS, DGO, MRCOG

CONTACT

656-772-5555; arundhati_gosavi@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 22, 2024
• Study Start: July 8, 2022
• Primary Completion: February 28, 2025
• Study Completion: July 30, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 8th July 2022 to 30th Jul 2025

Locations

SG (1)