Trial Outcomes & Findings for Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients (NCT NCT06232317)
NCT ID: NCT06232317
Last Updated: 2025-09-17
Results Overview
Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Within 1 month of enrolling in the study
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
Virtual Reality Software
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,
Traditional Orientation Methods: Standard-of-care methods to orient patients after surgery
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Baseline characteristics by cohort
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods
n=15 Participants
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,
Traditional Orientation Methods: Standard-of-care methods to orient patients after surgery
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 5 • n=93 Participants
|
69 years
STANDARD_DEVIATION 5 • n=4 Participants
|
67 years
STANDARD_DEVIATION 5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Body Mass Index (kg/m^2)
|
28.21 kg/m^2
STANDARD_DEVIATION 4.32 • n=93 Participants
|
26.38 kg/m^2
STANDARD_DEVIATION 6.08 • n=4 Participants
|
27.30 kg/m^2
STANDARD_DEVIATION 5.27 • n=27 Participants
|
|
Active smoker
Yes
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Active smoker
No
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
History of hypertension
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
History of diabetes
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
History of hypercholesterolemia
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 1 month of enrolling in the studyPercentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm.
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
n=15 Participants
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
|
0 percent
|
0 percent
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to VR software use and 10 minutes after VR software use. Change = 10-minute oxygen saturation - baseline oxygen saturation
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes
|
-1 percent oxygen saturation
Standard Deviation 2
|
—
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Respiratory Rate After 10 Minutes
|
0 breaths per minute
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute systolic blood pressure - baseline systolic blood pressure
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure After 10 Minutes
|
3.93 mm Hg
Standard Deviation 11.32
|
—
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure After 10 Minutes
|
2.33 mm Hg
Standard Deviation 4.55
|
—
|
SECONDARY outcome
Timeframe: Baseline and completion of the intervention, up to 2 hoursPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion oxygen saturation - baseline oxygen saturation
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion
|
-0.47 percent oxygen saturation
Standard Deviation 1.85
|
—
|
SECONDARY outcome
Timeframe: Baseline and completion of the intervention, up to 2 hoursPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Respiratory Rate After Completion
|
0 breaths per minute
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline and completion of the intervention, up to 2 hoursPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion systolic blood pressure - baseline systolic blood pressure
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure After Completion
|
-6.27 mm Hg
Standard Deviation 13.49
|
—
|
SECONDARY outcome
Timeframe: Baseline and completion of the intervention, up to 2 hoursPopulation: This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after software use. Change = completion diastolic blood pressure - baseline diastolic blood pressure
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure After Completion
|
-1.40 mm Hg
Standard Deviation 6.79
|
—
|
SECONDARY outcome
Timeframe: Baseline to discharge from hospital, up to 3 monthsThe proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
n=15 Participants
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Positive Confusion Assessment Method and/or 4 A's Test
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment in study to 24 hours after study enrollmentChange in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from start of intervention to end of intervention (experimental arm) or enrollment to 24 hours post-enrollment (control arm)
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
n=15 Participants
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
|
0 score on a scale
Interval -1.0 to 0.0
|
0 score on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure)Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to 10 minutes after beginning use (experimental arm) or enrollment to 8-16 hours post-enrollment (control arm)
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
n=15 Participants
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention
|
0 score on a scale
Interval -1.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 minutes after the start of software useFor participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
|
15 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useFor participants in the experimental (virtual reality) arm, the number of participants with a System Usability Scale (SUS) score \>35 on a scale of 0-100, where 0 is minimum and 100 is maximum; higher scores mean better usability.
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Number of Participants With a System Usability Scale (SUS) Score >35
|
12 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useThe proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Proportion of Participants Completing Game With No Errors
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useFor participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Number of Participants Completing Game on First Attempt
|
15 Participants
|
—
|
POST_HOC outcome
Timeframe: Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: at 8-16 hours after enrollment (one measure, window allowed for completing the measure)Whether change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to mid-intervention (experimental)/observation (control), grouped by whether the pain score increased, stayed the same (no change), or decreased
Outcome measures
| Measure |
Virtual Reality Software
n=15 Participants
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
|
Traditional Orientation Methods (Control)
n=15 Participants
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study.
|
|---|---|---|
|
Change in Virtual Analog Scale (VAS) Pain Score From Pre-virtual Reality Use to 10 Minutes After Beginning Use (Experimental Arm) or Enrollment to 8-16 Hours Post-enrollment (Control Arm)
Reduced
|
4 Participants
|
2 Participants
|
|
Change in Virtual Analog Scale (VAS) Pain Score From Pre-virtual Reality Use to 10 Minutes After Beginning Use (Experimental Arm) or Enrollment to 8-16 Hours Post-enrollment (Control Arm)
No Change
|
11 Participants
|
6 Participants
|
|
Change in Virtual Analog Scale (VAS) Pain Score From Pre-virtual Reality Use to 10 Minutes After Beginning Use (Experimental Arm) or Enrollment to 8-16 Hours Post-enrollment (Control Arm)
Increased
|
0 Participants
|
7 Participants
|
Adverse Events
Virtual Reality Software
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Orientation Methods
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hina Faisal
Department of Surgery, Houston Methodist Hospital
Phone: 713-714-4973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place