N/A
Completed N=30
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Surgery · Delirium · Delirium, Post-Operative
Source: ClinicalTrials.gov NCT06232317 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) — 0; 0 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) |
0; 0 | — |
| SECONDARY Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes |
-1 | — |
| SECONDARY Change From Baseline in Respiratory Rate After 10 Minutes |
— | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure After 10 Minutes |
3.93 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure After 10 Minutes |
2.33 | — |
| SECONDARY Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion |
-0.47 | — |
| SECONDARY Change From Baseline in Respiratory Rate After Completion |
— | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure After Completion |
-6.27 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure After Completion |
-1.40 | — |
| SECONDARY Positive Confusion Assessment Method and/or 4 A's Test |
0; 0 | — |
| SECONDARY Change in Visual Analog Scale (VAS) Pain Score |
0; 0 | 0.61 |
| SECONDARY Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention |
0; 0 | 0.014 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06232317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.