Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Percentage of Participants Using Virtual Reality Software at 20 Minutes after Start |
For participants in the experimental (virtual reality) arm, Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome) |
20 minutes after the start of software use |
|
| Other |
Participants With a System Usability Scale Score >35 |
For participants in the experimental (virtual reality) arm, the proportion of participants with a System Usability Scale score >35 on a scale of 0-100, where higher scores mean better usability. |
After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
| Other |
Proportion of Participants Completing Game with No Errors |
The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors |
After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
| Other |
Number of Attempts to Complete the Game |
For participants in the experimental (virtual reality) arm, the number of attempts a participant takes to complete the virtual reality game |
After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
| Other |
Number of Software and Device Restarts |
For participants in the experimental (virtual reality) arm, the number of times the virtual reality device needed to be restarted during game play |
After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
| Other |
Number of Software and Device Resets |
For participants in the experimental (virtual reality) arm, the number of times the virtual reality device needed to be reset during game play |
After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
| Primary |
Proportion of treatment-emergent adverse events (TEAE) |
Proportion of participants who experience a treatment-emergent adverse event |
Within 1 month of enrolling in the study |
|
| Secondary |
Change From Baseline in Pulse Oximetry Oxygen Saturation after 10 Minutes |
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and 10 minutes after intervention. Change = 10-minute oxygen saturation - baseline oxygen saturation |
Baseline and 10 minutes |
|
| Secondary |
Change from baseline in respiratory rate after 10 minutes |
Respiratory rate at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and 10 minutes after intervention. Change = 10-minute respiratory rate - baseline respiratory rate |
Baseline and 10 minutes |
|
| Secondary |
Change from baseline in systolic blood pressure after 10 minutes |
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and 10 minutes after intervention. Change = 10-minute systolic blood pressure - baseline systolic blood pressure |
Baseline and 10 minutes |
|
| Secondary |
Change from baseline in diastolic blood pressure after 10 minutes |
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and 10 minutes after intervention. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure |
Baseline and 10 minutes |
|
| Secondary |
Change from baseline in pulse oximetry oxygen saturation after completion |
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and after completion of intervention. Change = completion oxygen saturation - baseline oxygen saturation |
Baseline and completion of the intervention, up to 2 hours |
|
| Secondary |
Change from baseline in respiratory rate after completion |
Respiratory rate at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and after completion of intervention. Change = completion respiratory rate - baseline respiratory rate |
Baseline and completion of the intervention, up to 2 hours |
|
| Secondary |
Change from baseline in systolic blood pressure after completion |
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and after completion of intervention. Change = completion systolic blood pressure - baseline systolic blood pressure |
Baseline and completion of the intervention, up to 2 hours |
|
| Secondary |
Change from baseline in diastolic blood pressure after completion |
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention [VR software or traditional orientation methods]) and after completion of intervention. Change = completion diastolic blood pressure - baseline diastolic blood pressure |
Baseline and completion of the intervention, up to 2 hours |
|
| Secondary |
Positive Confusion Assessment Method and/or 4 A's Test |
The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium |
Baseline, 24 hours, 48 hours, 72 hours |
|
