Medical EducationViVaDeXNCT06653270
Virtual Reality Birth Simulator
A study testing Virtual reality simulator and Mannequin-based simulator in people with Medical Education and Normal Vaginal Delivery, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Normal Vaginal Delivery, Simulation Training
- What is being tested?
- Virtual reality simulator and Mannequin-based simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Jul 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical students undergoing their 4th year obstetrics and gynaecology clerkship
Who cannot join
- Declined to give consent or to have simulation videotaped
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Yong Loo Lin School of Medicine, National University of Singapore
Singapore
Arundhati Gosavi, MBBS, DGO, MRCOG, 656-772-5555, arundhati_gosavi@nuhs.edu.sg
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual reality simulator, Mannequin-based simulator
- Keywords
- Obstetrics, Labour, Vaginal delivery, Simulation training, Medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality simulatorOther
Also called ViVaDex
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
Mannequin-based simulatorOther
Legacy PROMPT Flex® mannequin
| Study group | Role | What they receive |
|---|---|---|
| Mannequin-based simulator | Active comparator | Legacy PROMPT Flex® mannequin Receives: 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 Receives: Other: Virtual reality simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage improvement in knowledge scores
Percentage of a knowledge quiz answered correctly before and after exposure to the first simulation device
Measured: The time frame of involvement for each participant is 4 hours.
Secondary outcomes (1)
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".
Measured: The time frame of involvement for each participant is 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start8 Jul 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653270
- Sponsor's protocol ID
- NUS-IRB-2020-606
- Acronym
- ViVaDeX
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Percentage correct from the knowledge questionanire, type of questionnaire and the constituents.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Simulation Training for Childbirth- a Cluster Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT06653270
- Acronym / sponsor ID
- ViVaDeX / NUS-IRB-2020-606
- Keywords
- Obstetrics, Labour, Vaginal delivery, Simulation training, Medical education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannequin-based simulator | Active comparator | Other: Mannequin-based simulatorLegacy PROMPT Flex® mannequin |
| Virtual-reality simulator | Active comparator | Other: Virtual reality simulatorA 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical students undergoing their 4th year obstetrics and gynaecology clerkship
Key exclusion criteria (1 listed)
- Declined to give consent or to have simulation videotaped
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality simulatorAlso: ViVaDexA 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 |
| Mannequin-based simulatorLegacy PROMPT Flex® mannequin | Other | Mannequin-based simulator |
Primary outcome
Percentage improvement in knowledge scores
Time frame: The time frame of involvement for each participant is 4 hours.
Percentage of a knowledge quiz answered correctly before and after exposure to the first simulation device
1 secondary outcome
Mean scores from the feedback questionnaire
Time frame: The time frame of involvement for each participant is 4 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Yes. Percentage correct from the knowledge questionanire, type of questionnaire and the constituents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality simulator and Mannequin-based simulator in people with Medical Education and Normal Vaginal Delivery, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arundhati Gosavi, MBBS, DGO, MRCOG (656-772-5555, arundhati_gosavi@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement in knowledge scores (time frame: The time frame of involvement for each participant is 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.