Randomised control trial comparing two methods of learning: the Cambridge Medical Robot virtual reality headset, and computer-based e-learning modules, for training the set up of the Cambridge Medical Robot in an operating theatre
| ISRCTN | ISRCTN10064213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10064213 |
- Submission date
- 23/06/2023
- Registration date
- 01/08/2023
- Last edited
- 11/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study aims to test the usability and effectiveness of a virtual reality headset which takes students through setting up a robotic machine in the operating theatre compared to an online learning programme currently used as part of the learning process.
Who can participate?
Medical students with no prior robotic exposure
What does the study involve?
Students will be randomly allocated into two groups: one will have the online e-learning resources, and the other will be issued a virtual reality headset which includes different tasks that ‘immerse’ them into an operating room environment where they can watch and practice the steps through virtual reality. They will be asked to complete either allocated resource within 2 weeks and attend the assessment thereafter.
What are the possible benefits and risks of participating?
The benefits of taking part include access to a new technology. Minor risks involve that of immersing into a virtual environment: a small risk of eye strain from using a VR headset for prolonged periods of time and will be cautioned against in the participant information sheet. It will be suggested participants use the headset in a space free of any wires/objects so as to not trip or collide with these in a virtual environment.
Where is the study run from?
Cardiff and Vale University Health Board (UK)
When is the study starting and how long is it expected to run for?
December 2022 to July 2023
Who is funding the study?
Cardiff and Vale University Health Board (UK)
Who is the main contact?
Catherine Eley, catherine.eley@wales.nhs.uk
Contact information
Principal Investigator
8 Heol Booths
St Ederyns Village
Old St Mellons
Cardiff
CF3 6WA
United Kingdom
 ORCID ID |
0000-0002-3485-0834 |
|---|---|
| Phone | +44 (0)7789996261 |
| catherine.eley@wales.nhs.uk |
Study information
| Study design | Single-centre interventional single-blinded randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Training facility/simulation, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | 43842_PIS_V2.pdf |
| Scientific title | VROBOT: Virtual Reality Or e-learning Better for robot Operating Theatre set up |
| Study acronym | VROBOT |
| Study objectives | Virtual reality training improves practical operating room set-up when compared to existing e-learning module training |
| Ethics approval(s) |
Approved 26/01/2023, Cardiff University School of Medicine Research Ethics Committee (Cardiff University, Heath Park, Cardiff, CF144XN, United Kingdom; +44 (0)2920687689; hcareethics@cardiff.ac.uk), ref: SMREC23/01 |
| Health condition(s) or problem(s) studied | Improvement of the set-up of the CMR Versius robot in an operating theatre |
| Intervention | Participants were randomised using an electronic randomiser into one of two groups. CMR (Cambridge Medical Robot) Virtual reality headsets were issued to the virtual reality training group and CMR e-learning credentials issued to the e-learning group. The assessors were blinded to the training intervention. The training method was issued and participants were given 2 weeks to complete either method. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CMR (Cambridge Medical Robot) virtual reality headset |
| Primary outcome measure | Improvement in operation theatre CMR versius robot set-up is measured using a modified CMR assessment sheet following the completion of either intervention. The overall score will be measured using the sum of 38 tasks using a Likert scale of 1-5 per task: Timepoint 0 hours; Total score /190 |
| Secondary outcome measures | Robot set-up self-assessed confidence: 1. Individual task scores will be measured using a Likert scale of 1-5 at 0 hours post-assessment: Timepoint 0 2. Time will be measured in minutes from the beginning to the end of the assessment: Timepoint 0 3. Self-assessed confidence scores will be assessed using a Likert scale of 1-5 at 0 hours post assessment |
| Overall study start date | 01/12/2022 |
| Completion date | 01/07/2023 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Medical students with no prior robotic experience 2. Access to a laptop and internet connection at home 3. Visually able to use the VR headset |
| Key exclusion criteria | 1. Those with prior education in setting up the CMR Versius robot 2. Those unable to use the VR headset |
| Date of first enrolment | 08/02/2023 |
| Date of final enrolment | 01/05/2023 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
Heath Park
Cardiff
CF144XW
Wales
United Kingdom
| Phone | +44 (0)2920747747 |
|---|---|
| james.ansell@wales.nhs.uk | |
| Website | http://www.cardiffandvaleuhb.wales.nhs.uk/home |
"ROR" |
https://ror.org/0489f6q08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Catherine Eley (catherine.eley@wales.nhs.uk). The type of data that will be shared: SPSS spreadsheet of anonymised data. Whether consent from participants was required and obtained: Consent was obtained via returned electronic consent form. Comments on data anonymization: Participants were assigned a participant ID and all data saved was done so anonymously using this study ID number. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 26/06/2023 | No | Yes | |
| Results article | 30/03/2024 | 11/09/2024 | Yes | No |
Additional files
Editorial Notes
11/09/2024: Publication reference added.
26/06/2023: Study's existence confirmed by the Cardiff University School of Medicine Research Ethics Committee.
