Delirium, Delirium, Post-Operative, Surgery
Conditions
Keywords
abdominal surgery, virtual reality
Brief summary
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
Detailed description
Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises. A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.
Interventions
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.
OTHERTraditional Orientation Methods
Standard-of-care methods to orient patients after surgery
Sponsors
National Institute on Aging (NIA)
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥60 years of age * Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy. * Richmond Agitation-Sedation Scale (RASS) Score 0
Exclusion criteria
* Subjects with baseline cognitive impairment * Person with active psychiatric disorders and being treated with medications, especially schizophrenia * Person who is deaf or blind * Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia) * Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions * Active seizure disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) | Within 1 month of enrolling in the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion | Baseline and completion of the intervention, up to 2 hours | 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 |
| Change From Baseline in Diastolic Blood Pressure After Completion | Baseline and completion of the intervention, up to 2 hours | 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 |
| Positive Confusion Assessment Method and/or 4 A's Test | Baseline to discharge from hospital, up to 3 months | The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium |
| Change in Visual Analog Scale (VAS) Pain Score | Enrollment in study to 24 hours after study enrollment | Change 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) |
| Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention | 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) |
| Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes | Baseline and 10 minutes | 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 |
| Change From Baseline in Respiratory Rate After 10 Minutes | Baseline and 10 minutes | Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate |
| Change From Baseline in Systolic Blood Pressure After 10 Minutes | Baseline and 10 minutes | 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 |
| Change From Baseline in Diastolic Blood Pressure After 10 Minutes | Baseline and 10 minutes | 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 |
| Change From Baseline in Respiratory Rate After Completion | Baseline and completion of the intervention, up to 2 hours | Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate |
| Change From Baseline in Systolic Blood Pressure After Completion | Baseline and completion of the intervention, up to 2 hours | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Completing Game With No Errors | After completion of use of the virtual reality software, up to 2 hours after the start of software use | The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors |
| Number of Participants Completing Game on First Attempt | After completion of use of the virtual reality software, up to 2 hours after the start of software use | For participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt |
| Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | 20 minutes after the start of software use | For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software |
| Number of Participants With a System Usability Scale (SUS) Score >35 | After completion of use of the virtual reality software, up to 2 hours after the start of software use | For 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Virtual Reality Software | Total | Traditional Orientation Methods |
|---|---|---|---|
| Active smoker No | 10 Participants | 19 Participants | 9 Participants |
| Active smoker Yes | 5 Participants | 11 Participants | 6 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 5 | 67 years STANDARD_DEVIATION 5 | 69 years STANDARD_DEVIATION 5 |
| Body Mass Index (kg/m^2) | 28.21 kg/m^2 STANDARD_DEVIATION 4.32 | 27.30 kg/m^2 STANDARD_DEVIATION 5.27 | 26.38 kg/m^2 STANDARD_DEVIATION 6.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of diabetes | 3 Participants | 7 Participants | 4 Participants |
| History of hypercholesterolemia | 9 Participants | 17 Participants | 8 Participants |
| History of hypertension | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 22 Participants | 13 Participants |
| Sex: Female, Male Female | 6 Participants | 17 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
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.
Time frame: Within 1 month of enrolling in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Reality Software | Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) | 0 percent |
| Traditional Orientation Methods (Control) | Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) | 0 percent |
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 virtual reality software use) and 10 minutes after software use. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure
Time frame: Baseline and 10 minutes
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Diastolic Blood Pressure After 10 Minutes | 2.33 mm Hg | Standard Deviation 4.55 |
Secondary
Change From Baseline in Diastolic Blood Pressure After Completion
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
Time frame: Baseline and completion of the intervention, up to 2 hours
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Diastolic Blood Pressure After Completion | -1.40 mm Hg | Standard Deviation 6.79 |
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 VR software use and 10 minutes after VR software use. Change = 10-minute oxygen saturation - baseline oxygen saturation
Time frame: Baseline and 10 minutes
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes | -1 percent oxygen saturation | Standard Deviation 2 |
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 virtual reality software use) and after completion of software use. Change = completion oxygen saturation - baseline oxygen saturation
Time frame: Baseline and completion of the intervention, up to 2 hours
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion | -0.47 percent oxygen saturation | Standard Deviation 1.85 |
Secondary
Change From Baseline in Respiratory Rate After 10 Minutes
Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate
Time frame: Baseline and 10 minutes
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Respiratory Rate After 10 Minutes | 0 breaths per minute | Standard Deviation 0 |
Secondary
Change From Baseline in Respiratory Rate After Completion
Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate
Time frame: Baseline and completion of the intervention, up to 2 hours
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Respiratory Rate After Completion | 0 breaths per minute | Standard Deviation 0 |
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 virtual reality software use) and 10 minutes after software use. Change = 10-minute systolic blood pressure - baseline systolic blood pressure
Time frame: Baseline and 10 minutes
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Systolic Blood Pressure After 10 Minutes | 3.93 mm Hg | Standard Deviation 11.32 |
Secondary
Change From Baseline in Systolic Blood Pressure After Completion
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
Time frame: Baseline and completion of the intervention, up to 2 hours
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software | Change From Baseline in Systolic Blood Pressure After Completion | -6.27 mm Hg | Standard Deviation 13.49 |
Secondary
Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention
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)
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality Software | Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention | 0 score on a scale |
| Traditional Orientation Methods (Control) | Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention | 0 score on a scale |
p-value: 0.014Kruskal-Wallis
Secondary
Change in Visual Analog Scale (VAS) Pain Score
Change 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)
Time frame: Enrollment in study to 24 hours after study enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality Software | Change in Visual Analog Scale (VAS) Pain Score | 0 score on a scale |
| Traditional Orientation Methods (Control) | Change in Visual Analog Scale (VAS) Pain Score | 0 score on a scale |
p-value: 0.61Kruskal-Wallis
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
Time frame: Baseline to discharge from hospital, up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software | Positive Confusion Assessment Method and/or 4 A's Test | 0 Participants |
| Traditional Orientation Methods (Control) | Positive Confusion Assessment Method and/or 4 A's Test | 0 Participants |
Post Hoc
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)
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
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual Reality Software | 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 |
| Virtual Reality Software | 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 |
| Virtual Reality Software | 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 |
| Traditional Orientation Methods (Control) | 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 | 2 Participants |
| Traditional Orientation Methods (Control) | 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 | 6 Participants |
| Traditional Orientation Methods (Control) | 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 | 7 Participants |
p-value: 0.011Fisher Exact
Other Pre-specified
Number of Participants Completing Game on First Attempt
For participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software | Number of Participants Completing Game on First Attempt | 15 Participants |
Other Pre-specified
Number of Participants With a System Usability Scale (SUS) Score >35
For 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.
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software | Number of Participants With a System Usability Scale (SUS) Score >35 | 12 Participants |
Other Pre-specified
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software
Time frame: 20 minutes after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software | Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | 15 Participants |
Other Pre-specified
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
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software | Proportion of Participants Completing Game With No Errors | 3 Participants |