Is learning together in virtual reality better than learning individually for surgical teams training for complex operations?

ISRCTN ISRCTN32225943
DOI https://doi.org/10.1186/ISRCTN32225943
IRAS number 237607
Secondary identifying numbers IRAS 237607
Submission date
23/08/2022
Registration date
24/08/2022
Last edited
29/12/2023
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
There is good evidence that effective teamwork in surgery is linked to fewer surgical errors and better patient outcomes. Virtual reality is excellent way to train surgeons and scrub nurses individually, however could also be used to train them together in a team. This study aims to use an innovative multiplayer virtual reality training platform to test whether the training together approach is better than learning separately for novices learning a complex open operation. This complex open operation is performing a hip replacement, accessing it from the front of the hip rather than the more usual approach from the back.

Who can participate?
Junior surgeons with less than 5 years experience for the surgeon role, student nurses, medical students and newly qualified scrub nurses with less than 1 year experience for the scrub nurse role. They must have no experience with performing hip replacements coming in from the front of the hip

What does the study involve?
Participants will be randomised to learning in a team or individually. They will all undergo 5 sessions of immersive virtual reality training. In this training they will enter a virtual operating theatre and will be guided on performing their role within the operation (surgeon or scrub nurse). The only difference will be that those assigned to the team group will do the training together live in pairs, whereas the individually trained group will learn separately with a computer avatar playing the alternative role. Otherwise training will be identical. Following the 5th session they will all undergo a real world assessment. Teams will perform this together in their training teams, individual participants will be randomly paired up with a member of the alternative role. The assessment will take place in a simulated operating theatre, with real equipment and on an anatomical model. They will be asked to perform the operation as they learned in virtual reality. They will be marked on their team work, technical performance by blinded expert assessors.

What are the possible benefits and risks of participating?
This is a non-interventional study and so the risks are very small. Some people get headaches or eye strain from the virtual reality training, and there is a small risk using the sharps/drills/saws in the real world assessment. The benefits are that if this method of training proves beneficial it could be rolled out across health services and may benefit patients in the long term

Where is the study run from?
MSk Lab at Imperial College London (UK)

When is the study starting and how long will it run for?
March 2021 to October 2022

Who is funding the study?
Johnson and Johnson (UK)

Who is the main contact?
Mr Thomas Edwards, thomas.edwards@imperial.ac.uk

Contact information

Prof Justin Cobb
Principal Investigator

MSk Lab, Sir Michael Uren Hub
White City Campus
82 Wood Lane
Imperial College London
London
W12 0BZ
United Kingdom

ORCiD logoORCID ID 0000-0002-6095-8822
Phone +44 20 7594 2725
Email j.cobb@imperial.ac.uk

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleCollaborative training vs individual training in immersive virtual reality: A randomised controlled trial for novices learning complex open surgery
Study objectivesMultiplayer team training in immersive virtual reality will be superior to individual training for novices learning anterior approach total hip replacements
Ethics approval(s)Approved 10/04/2018, Health Research Authority (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 207 104 8000; contact@hra.nhs.uk), ref: 18/HRA/2085
Health condition(s) or problem(s) studiedEducational study examining learning complex surgery in virtual reality
InterventionAt enrolment in the study, the following baseline data is collected: Baseline knowledge assessed using a written assessment developed through expert consensus, baseline demographics: Age, sex, handedness, video game experience, virtual reality experience, role, experience with anterior approach THR, experience with THRs any approach
Randomisation: Block randomisation in a 1:1 ratio performed by an external trial manager using a computer generated random number sequence, allocation concealed until participants have been enrolled in the study. Participants allocated to one of tow parallel groups:
Team training arm: The invention is learning anterior approach total hip replacement surgery in a multiplayer virtual reality platform. Surgeons and scrub nurses work together to learn how to perform their roles in the operations
Individual training arm: The intervention is learning anterior approach total hip replacement surgery in a more conventional single player mode, where the alternative role is played by a computer avatar. Otherwise the training is identical
Each group goes through 5 virtual reality training sessions over a 6 week period, following the 5th and final session they all undergo a real world, assessment in a simulated operating theatre with real equipment and on a validated model hip.
Final follow up is immediately following the real world assessment at 6 weeks
Intervention typeOther
Primary outcome measureNontechnical performance in a simulated real world assessment using the NOTSS score (Non-Operative Technical Skills for Surgeons) at baseline and 6 weeks
Secondary outcome measuresAt baseline and 6 weeks:
1. Nontechnical performance in simulated real world assessment using NOTECHS II Score, SPLINTS Scores. 2. Technical performance in simulated real world assessment, using an expert derived task specific checklist, acetabular component positioning (anteversion and inclinicaton), procedure time.
Overall study start date01/03/2021
Completion date01/10/2022

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants40
Total final enrolment40
Key inclusion criteriaSurgeons: training surgeons FY2 - ST4 level, No experience performing supervised total hip replacements via the anterior approach, <10 THAs performed supervised using any approach. No previous orthopaedic or open virtual reality surgical simulation training

Scrub technician: Student nurses, Newly qualified scrub nurses or ODPs with < 1 year experience in orthopaedic surgery, Medical students. No experience scrubbing for anterior approach THR surgery, no specific training in THR instrumentation or technique, No experience of virtual reality surgical simulation
Key exclusion criteriaSurgeons: Performed supervised > 10 THR operations any approach, Performed supervised any anterior approach THA's, previous open or orthopaedic surgical virtual reality simulation training

Scrub nurses: > 1 year orthopaedic scrub nurse experience, specific training in THR instrumentation/ technique, scrubbed for any anterior approach THA operations, previous surgical virtual reality simulation training
Date of first enrolment01/04/2021
Date of final enrolment01/10/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Imperial College London
MSk Lab
2nd Floor, Sir Michael Uren Hub
White City Campus
Imperial College London
82 Wood Lane
London
W12 0BZ
United Kingdom

Sponsor information

Imperial College London
University/education

Rm 221, Level 2 Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom

Phone +44 2075949832
Email cheuk-fund.wong@imperial.ac.uk
Website http://www.imperial.ac.uk/
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Industry

Johnson and Johnson
Government organisation / For-profit companies (industry)
Alternative name(s)
Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
Location
United States of America

Results and Publications

Intention to publish date01/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlaned publication in a high-impact peer-reviewed journal
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/12/2023 29/12/2023 Yes No

Editorial Notes

29/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
24/08/2022: Trial's existence confirmed by NHS HRA.