Educational StudyNCT06350708
Virtual Reality (VR) Paediatric Tracheostomy Training
A study testing Virtual reality (VR) tracheostomy educational tool in people with Educational Study, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Study
- What is being tested?
- Virtual reality (VR) tracheostomy educational tool
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to 10 Jul 2024
- 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 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare student
- Clinical experience needed
- Healthcare staff
- Based at Manchester University Foundation Trust, or The University of Manchester
Who cannot join
- Not a healthcare student
- Not a healthcare student - have no clinical experience
- Not healthcare staff but working in the National Health Service
- Not based at Manchester University Foundation Trust, or The University of Manchester
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9PL
Jonathan R Abbas, MBChB, jonathan.abbas@postgrad.manchester.ac.uk
About this study
Official title: Can Remote Training of Paediatric Emergency Tracheostomy Simulation be Performed Using VR Technology?
This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.
- Conditions
- Educational Study
- Being tested
- Virtual reality (VR) tracheostomy educational tool
- Keywords
- virtual reality, tracheostomy, training, paediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) tracheostomy educational toolOther
This is an unsupervised VR training packaged designed to train healthcare professionals and their students the management of the paediatric tracheostomy emergency.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed)
Test the improvement in simulated performance in a pre- and post-test method.
Time to key specific intervention and total scenario times will be measured in seconds, with a smaller number indicating better performance.
Number of correct interventions will be simple numerical with higher number indicating better performance.
Measured: Measured at the beginning of study and 1 week.
Secondary outcomes (4)
Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank.
Measurement of knowledge in a pre- and post-test method. The a higher score will indicate more knowledge. Minimum values are 0, maximum value of 23.
Measured: Measured at the beginning of study,1 week and 4 weeks post intervention.
Participant satisfaction measured using a bespoke data collection tool.
Likert questionnaire
Measured: 1 week post initiation of intervention
Virtual Reality Sickness
Measure of participant comfort using the validated Virtual Reality Sickness Questionnaire.
Lower score is better. The score can range from 0-27.
Measured: 1 week post initiation of intervention
Usability using the validated system usability scale
Measure of usability using the validated System Usability Scale
Calculation of the score is complex, and will follow the guidance in the below academic work:
https://www.researchgate.net/publication/228593520_SUS_A_quick_and_dirty_usability_scale
Measured: 1 week post initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational StudyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Abass, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350708
- Sponsor's protocol ID
- 2024-18304-33663
- Other IDs
- 336664
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbas JR, Younis N, Johnstone E, Rajai A, Isba R, Payton A, McGrath BA, Tolley N, Bruce IA. Use of virtual reality to remotely train healthcare professionals in paediatric emergency tracheostomy skills: protocol for a multi-centre, non-inferiority educational interventional study with historical controls. BMC Surg. 2025 Jan 15;25(1):25. doi: 10.1186/s12893-024-02736-1.
PubMed 39810190
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Remote Training of Paediatric Emergency Tracheostomy Simulation be Performed Using VR Technology?
- ClinicalTrials.gov ID
- NCT06350708
- Acronym / sponsor ID
- 2024-18304-33663
- Conditions
- Educational Study
- Keywords
- virtual reality, tracheostomy, training, paediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 5 Apr 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.
This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthcare student
- Clinical experience needed
- Healthcare staff
- Based at Manchester University Foundation Trust, or The University of Manchester
Key exclusion criteria (4 listed)
- Not a healthcare student
- Not a healthcare student - have no clinical experience
- Not healthcare staff but working in the National Health Service
- Not based at Manchester University Foundation Trust, or The University of Manchester
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 (VR) tracheostomy educational toolThis is an unsupervised VR training packaged designed to train healthcare professionals and their students the management of the paediatric tracheostomy emergency. | Other | – |
Primary outcome
Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed)
Time frame: Measured at the beginning of study and 1 week.
Test the improvement in simulated performance in a pre- and post-test method. Time to key specific intervention and total scenario times will be measured in seconds, with a smaller number indicating better performance. Number of correct interventions will be simple numerical with higher number indicating better performance.
4 secondary outcomes
Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank.
Time frame: Measured at the beginning of study,1 week and 4 weeks post intervention.
Participant satisfaction measured using a bespoke data collection tool.
Time frame: 1 week post initiation of intervention
Virtual Reality Sickness
Time frame: 1 week post initiation of intervention
Usability using the validated system usability scale
Time frame: 1 week post initiation of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 39810190Abbas JR, Younis N, Johnstone E, Rajai A, Isba R, Payton A, McGrath BA, Tolley N, Bruce IA. Use of virtual reality to remotely train healthcare professionals in paediatric emergency tracheostomy skills: protocol for a multi-centre, non-inferiority educational interventional study with historical controls. BMC Surg. 2025 Jan 15;25(1):25. doi: 10.1186/s12893-024-02736-1.
- Individual participant dataSharing planned: No
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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 (VR) tracheostomy educational tool in people with Educational Study, run by University of Manchester at 1 site in United Kingdom.
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 4 inclusion and 4 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 5 Apr 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed) (time frame: Measured at the beginning of study and 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06350708, which also lists 1 linked publication.
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 5 Apr 2024.