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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Cardiff and Vale University Health Board
Funder	Cardiff and Vale University Health Board

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Miss Catherine Eley
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
Email	catherine.eley@wales.nhs.uk

Study information

Primary study design	Interventional
Study design	Single-centre interventional single-blinded randomized control trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	CMR (Cambridge Medical Robot) virtual reality headset
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/07/2023

Eligibility

Participant type(s)	Learner/student
Age group	Adult
Sex	All
Target sample size at registration	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

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article		30/03/2024	11/09/2024	Yes	No
Participant information sheet	version 2		26/06/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

43842_PIS_V2.pdf: Participant information sheet

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.