- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350708
Virtual Reality (VR) Paediatric Tracheostomy Training
Can Remote Training of Paediatric Emergency Tracheostomy Simulation be Performed Using VR Technology?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Greater Manchester
-
Manchester, Greater Manchester, United Kingdom, M13 9PL
- University of Manchester
-
Contact:
- Jonathan R Abbas, MBChB
- Email: jonathan.abbas@postgrad.manchester.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthcare student
- Clinical experience needed
- Healthcare staff
- Based at Manchester University Foundation Trust, or The University of Manchester
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Measured at the beginning of study and 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 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
|
Likert questionnaire
|
1 week post initiation of intervention
|
|
Virtual Reality Sickness
Time Frame: 1 week post initiation of intervention
|
Measure of participant comfort using the validated Virtual Reality Sickness Questionnaire. Lower score is better. The score can range from 0-27. |
1 week post initiation of intervention
|
|
Usability using the validated system usability scale
Time Frame: 1 week post initiation of intervention
|
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 |
1 week post initiation of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-18304-33663
- 336664 (Other Identifier: Integrated Research Application System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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