Virtual RealityNCT06861907
IMPRINT VR Trainer Evaluation
An observational study of Virtual Reality, run by Charles River Analytics at 1 site in United States.
Trial summary
The goal of this study is to assess whether the Immersive Modular Preparedness Intelligent Tutor (IMPRINT) virtual reality (VR) training modules provide a measurable benefit in training delivery and trainee engagement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 30 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: American Indian or Alaskan Native: .01% Asian: 9% Black or African American: 9.9% Hispanic or Latinx: 20.5% Native Hawaiian or other Islander: 0% Multiple Race, Non-Hispanic: 0% White: 56.7%
Who may be able to join
- Students taking the 40-hr HAZWOPER course at The New England Consortium
- Trainers teaching the 40-hr HAZWOPER course at The New England Consortium
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
The New England Consortium
Lowell, Massachusetts, 01854
About this study
Official title: IMPRINT Randomized Evaluation
The goal of this study is to assess whether the Immersive Modular Preparedness Intelligent Tutor (IMPRINT) virtual reality (VR) training modules provide a measurable benefit in training delivery and trainee engagement. Specifically, the investigators want to see how VR can enhance trainees' comprehension and retention of key HAZWOPER concepts, and how it supports you as trainers in presenting these materials more effectively.
Read the detailed description
IMPRINT aims to enhance trainee performance and set operational expectations outside of the hot zone in hyper-realistic exercises that challenge physical, psychological, and cognitive capabilities through adaptive behavioral science enhanced VR modules and seamlessly integrate with HAZWOPER training.
The investigators anticipate trainees and classes assigned to the intervention will perform better than those who use standard paper and PowerPoint based activities. The investigators believe their comprehension of topics will be greater, and it is likely that they will have a greater ability to recall HAZWOPER guidelines in the field. The investigators also anticipate after class survey results will indicate a better HAZWOPER training experience and increased levels of satisfaction with the course.
Additionally, the investigators anticipate that trainers using the IMPRINT VR modules will find the tool more effective and engaging compared to standard PowerPoint and video-based training methods. The investigators expect that trainers will report greater ease in delivering complex HAZWOPER concepts and that the VR modules will enhance their ability to facilitate trainee comprehension and recall of HAZWOPER guidelines. We also anticipate that trainer feedback will reflect a more positive teaching experience and higher levels of satisfaction with the training process.
Long-term benefits of participation include improvement in retention of HAZWOPER guidelines when responding to Hazardous Material (HAZMAT) disasters. The investigators anticipate trainees and classes assigned to the intervention will perform better than those who use standard paper and PowerPoint based activities. The investigators believe their comprehension of topics will be greater, and it is likely that they will have a greater ability to recall HAZWOPER guidelines in the field. The investigators also anticipate after class survey results will indicate a better HAZWOPER training experience and increased levels of satisfaction with the course.
To successfully transfer skills and develop trainees' procedural cognitive maps VR training systems must enable full immersion into training exercises by integrating PPE, enabling 3D object haptic interaction and natural walking to support spatial skill development, and provide trainer support. Research has shown significant performance benefits from VR delivered targeted mission rehearsal. To realize these benefits before facing real emergencies, trainees must have the opportunity to hone their skills in a controlled setting that mimics real-life scenarios as closely as possible through fully immersive exercises. This immersive context driven approach is critical for skill transfer and well understood in parallel domains. Immersion is best achieved through a combination of sensations, including haptic (tactile touch, force feedback, temperature, etc.), audio, and visual (simulated detector reads of simulated radiation). Several recent empirical assessments of VR systems demonstrate superior skill transfer when haptic immersion is integrated in a domain appropriate way (e.g., heat exposure fire training, or stress inducing stimuli for disaster response).
It is not known whether this skill transfer occurs within the HAZMAT domain, or how to best operationalize these findings within training.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality
- Keywords
- HAZWOPER, HAZMAT, Training, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality Modules created to simulate HAZWOPER PowerPoint scenarios
| Study group | Role | What they receive |
|---|---|---|
| Trainers | Trainers responsible to teaching the 40-hr HAZWOPER course. They are experts in their field and have the most familiarity with the traditional PowerPoint training Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
SUS measures the usability of a system or interface. Higher scores on SUS indicate better usability. Typically, SUS scores are standardized to a scale of 0 to 100, where a score above 68 is considered above average usability, and scores above 80 indicate excellent usability
Measured: Immediately after the intervention
NASA TLX
The NASA TLX is a scale from 0 - 100 and measures perceived workload across different domains such as mental demand, physical demand, temporal demand, performance, effort, and frustration. Higher NASA TLX scores indicate higher perceived workload, meaning that a lower score generally suggests a better outcome in terms of reduced workload. However, for this effort, we are specifically assessing whether the workload in VR aligns with the high workload typically experienced during an actual HAZWOPER incident
Measured: Immediately after the intervention
Secondary outcomes (1)
User satisfaction with the VR modules
User satisfaction with the VR modules, evaluated through post-session surveys. This was accomplished as part of the debrief Q and A
Measured: Post Study / after completing all interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start8 Oct 2024
- Primary completion10 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles River Analytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), The New England Consortium
- Responsible party
- Principal investigator, E Vincent Cross, Charles River Analytics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861907
- Sponsor's protocol ID
- CharlesRiverA
- Other IDs
- 2R44ES031818-02
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPRINT Randomized Evaluation
- ClinicalTrials.gov ID
- NCT06861907
- Acronym / sponsor ID
- CharlesRiverA
- Conditions
- Virtual Reality
- Keywords
- HAZWOPER, HAZMAT, Training, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Charles River AnalyticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), The New England Consortium
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 6 Mar 2025 (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.
The goal of this study is to assess whether the Immersive Modular Preparedness Intelligent Tutor (IMPRINT) virtual reality (VR) training modules provide a measurable benefit in training delivery and trainee engagement. Specifically, the investigators want to see how VR can enhance trainees' comprehension and retention of key HAZWOPER concepts, and how it supports you as trainers in presenting these materials more effectively.
Detailed description
IMPRINT aims to enhance trainee performance and set operational expectations outside of the hot zone in hyper-realistic exercises that challenge physical, psychological, and cognitive capabilities through adaptive behavioral science enhanced VR modules and seamlessly integrate with HAZWOPER training.
The investigators anticipate trainees and classes assigned to the intervention will perform better than those who use standard paper and PowerPoint based activities. The investigators believe their comprehension of topics will be greater, and it is likely that they will have a greater ability to recall HAZWOPER guidelines in the field. The investigators also anticipate after class survey results will indicate a better HAZWOPER training experience and increased levels of satisfaction with the course.
Additionally, the investigators anticipate that trainers using the IMPRINT VR modules will find the tool more effective and engaging compared to standard PowerPoint and video-based training methods. The investigators expect that trainers will report greater ease in delivering complex HAZWOPER concepts and that the VR modules will enhance their ability to facilitate trainee comprehension and recall of HAZWOPER guidelines. We also anticipate that trainer feedback will reflect a more positive teaching experience and higher levels of satisfaction with the training process.
Long-term benefits of participation include improvement in retention of HAZWOPER guidelines when responding to Hazardous Material (HAZMAT) disasters. The investigators anticipate trainees and classes assigned to the intervention will perform better than those who use standard paper and PowerPoint based activities. The investigators believe their comprehension of topics will be greater, and it is likely that they will have a greater ability to recall HAZWOPER guidelines in the field. The investigators also anticipate after class survey results will indicate a better HAZWOPER training experience and increased levels of satisfaction with the course.
To successfully transfer skills and develop trainees' procedural cognitive maps VR training systems must enable full immersion into training exercises by integrating PPE, enabling 3D object haptic interaction and natural walking to support spatial skill development, and provide trainer support. Research has shown significant performance benefits from VR delivered targeted mission rehearsal. To realize these benefits before facing real emergencies, trainees must have the opportunity to hone their skills in a controlled setting that mimics real-life scenarios as closely as possible through fully immersive exercises. This immersive context driven approach is critical for skill transfer and well understood in parallel domains. Immersion is best achieved through a combination of sensations, including haptic (tactile touch, force feedback, temperature, etc.), audio, and visual (simulated detector reads of simulated radiation). Several recent empirical assessments of VR systems demonstrate superior skill transfer when haptic immersion is integrated in a domain appropriate way (e.g., heat exposure fire training, or stress inducing stimuli for disaster response).
It is not known whether this skill transfer occurs within the HAZMAT domain, or how to best operationalize these findings within training.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trainers | – | Device: Virtual RealityTrainers responsible to teaching the 40-hr HAZWOPER course. They are experts in their field and have the most familiarity with the traditional PowerPoint training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- American Indian or Alaskan Native: .01% Asian: 9% Black or African American: 9.9% Hispanic or Latinx: 20.5% Native Hawaiian or other Islander: 0% Multiple Race, Non-Hispanic: 0% White: 56.7%
Key inclusion criteria (2 listed)
- Students taking the 40-hr HAZWOPER course at The New England Consortium
- Trainers teaching the 40-hr HAZWOPER course at The New England Consortium
Key exclusion criteria (1 listed)
- N/A
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 RealityVirtual Reality Modules created to simulate HAZWOPER PowerPoint scenarios | Device | Trainers |
Primary outcome
System Usability Scale
Time frame: Immediately after the intervention
SUS measures the usability of a system or interface. Higher scores on SUS indicate better usability. Typically, SUS scores are standardized to a scale of 0 to 100, where a score above 68 is considered above average usability, and scores above 80 indicate excellent usability
NASA TLX
Time frame: Immediately after the intervention
The NASA TLX is a scale from 0 - 100 and measures perceived workload across different domains such as mental demand, physical demand, temporal demand, performance, effort, and frustration. Higher NASA TLX scores indicate higher perceived workload, meaning that a lower score generally suggests a better outcome in terms of reduced workload. However, for this effort, we are specifically assessing whether the workload in VR aligns with the high workload typically experienced during an actual HAZWOPER incident
1 secondary outcome
User satisfaction with the VR modules
Time frame: Post Study / after completing all interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virtual Reality, run by Charles River Analytics at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.