Clinical trial NCT06653270: Virtual Reality Birth Simulator
Official title: Virtual Reality Simulation Training for Childbirth- a Cluster Randomised Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Education
Normal Vaginal Delivery
Simulation Training
Virtual Reality
Keywords: Obstetrics
Labour
Vaginal delivery
Simulation training
Medical education
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percentage improvement in knowledge scores
timeFrame: The time frame of involvement for each participant is 4 hours.
Secondary outcomes:
measure: Mean scores from the feedback questionnaire
timeFrame: The time frame of involvement for each participant is 4 hours.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yong Loo Lin School of Medicine, National University of Singapore
Study officials:
References: