Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients (NCT06232317), a randomized na study. The primary outcome is Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE).

2. Clinical Question

The study was registered as a randomized comparison, but the primary endpoint asks about the proportion of participants with an event rather than a change in cognition. The registry lists delirium and postoperative delirium among the conditions of interest, while its stated study aim emphasizes feasibility, acceptability, and safety. The primary endpoint therefore addresses whether adverse events were reported during the stated observation period; it does not, on its own, answer whether the intervention changes delirium risk.

The record reports results for 15 participants in each arm. The primary endpoint value is 0.0% for each group. Because the posted analysis does not provide an estimable two-arm comparison, the arm values should be read as descriptive results rather than as a quantified comparative effect. The clinical question is correspondingly narrow: the registry reports no treatment-emergent adverse events in either arm, but the available result does not establish the relative safety of the approaches beyond these observed study data.

3. Trial Design

This was a randomized, parallel-group study with no masking. The experimental arm used ReCognitionVR virtual reality software for cognitive exercises; the control arm used traditional orientation methods described as standard of care. The record lists the study as completed, with enrollment of 30. Its start date is 2023-12-09 and its primary completion date is 2024-03-21.

The registry describes a feasibility and acceptability study in older surgical patients, with safety also among its aims. It says the findings would inform the design of a future study in critically ill hospitalized patients at risk for delirium. That stated purpose matters when interpreting the small-group descriptive results: the study is presented as an early assessment of an approach and its use in a particular surgical population, not as a definitive test of clinical benefit.

The primary outcome is the percentage of participants experiencing a treatment-emergent adverse event within 1 month of enrolling. The listed secondary outcomes include changes from baseline in pulse oximetry oxygen saturation, respiratory rate, systolic blood pressure, and diastolic blood pressure after 10 minutes and after completion. The registry lists 17 outcome measures and 11 posted secondary outcomes. It also reports 3 analyses, but their specific statistical methods and relationship to individual outcomes are not reported in the registry record.

Randomization indicates that assignment was intended to be by chance, but the sequence-generation method, concealment procedures, and any stratification are not reported in the registry record. With masking listed as none, participants and study personnel were not masked according to the registry classification. The extent to which outcome assessment was masked is not reported in the registry record. The record also does not report further details about recruitment, adherence, withdrawal, or how the two exercise approaches were delivered.

The study is listed with phase NA. No sample-size justification, interim-analysis plan, or prespecified statistical analysis plan is reported in the registry record. Those omissions limit the ability to judge how the design anticipated uncertainty, multiple outcomes, or missing observations.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE), measured over Within 1 month of enrolling in the study.

The primary endpoint is the percentage of participants who experience a treatment-emergent adverse event in the virtual reality software arm compared with the traditional orientation methods arm. Its stated timeframe is within 1 month of enrolling in the study. A percentage expresses the observed event frequency relative to the number of participants at risk in an arm. For this endpoint, the registry reports 0.0% in each arm, with 15 participants in each arm.

A safety endpoint is relevant to an intervention that involves cognitive exercises and virtual reality equipment because it records adverse events arising after treatment begins. It is distinct from an efficacy endpoint: it does not directly measure cognition, delirium, functional recovery, or acceptability. Feasibility and acceptability are named study aims, but the primary endpoint is specifically about treatment-emergent adverse events.

Both posted arm values are zero, so the descriptive results indicate that no participants were reported as experiencing a treatment-emergent adverse event in either group. However, the registry does not provide an estimable two-arm comparison. There is no posted confidence interval or other quantified estimate of comparative uncertainty. A zero observed event frequency in these groups does not show that the underlying event risk is zero; the amount of uncertainty around rare events cannot be judged fully from the percentages alone.

The registry does not report a more detailed event definition, the method used to determine whether an event was treatment-emergent, or additional information on how events were collected. Those details would help clarify exactly what was counted and how consistently events were identified.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a percentage endpoint represent?

For a binary safety outcome, each participant is classified according to whether the event occurred during the defined observation period. The arm percentage describes the fraction of participants with an event, expressed as a percentage. In this study, the primary endpoint is the percentage with a treatment-emergent adverse event within 1 month of enrolling. The registry reports 0.0% in each arm and lists 15 participants in each arm.

A percentage is a descriptive summary. To compare arms statistically, an analysis would ordinarily quantify the difference or another relative measure and describe uncertainty around that estimate. A confidence interval is a range constructed by a statistical procedure to express the precision of an estimate under its assumptions. It is not a guarantee that the true value lies within that range. No confidence interval or estimable two-arm effect is reported for this primary count outcome.

Why can zero events leave substantial uncertainty?

General statistical principle: observing no events does not imply that the underlying event probability is exactly zero. When events are uncommon, a study can observe none even when the underlying risk is not zero. The amount of uncertainty depends on the number of observations and the statistical method used. Reporting only a zero percentage does not show the full range of plausible underlying risks.

Comparisons of sparse binary outcomes can also be difficult to estimate. General statistical principle: standard methods for comparing proportions may rely on approximations that work poorly when event counts are very small or absent. Methods designed for sparse data may produce estimates or intervals under additional assumptions, but the choice of method should be specified and reported. The registry record does not report a method that yields a two-arm comparison for this endpoint. The posted analysis indicates that values were missing or not estimable for a two-arm comparison of this count outcome.

What does randomization contribute?

General statistical principle: random assignment can reduce systematic differences between groups at the time of assignment, on average, when implemented as intended. It does not ensure that every characteristic is balanced in a small study, and it does not correct problems caused by missing outcomes, unequal adherence, or biased event ascertainment. The registry identifies the allocation as randomized but does not report how the assignment sequence was generated or concealed. These procedural details are important for evaluating the protection randomization provides against selection bias.

The parallel model means the study compared groups assigned to different approaches rather than describing a crossover in which each participant received both. Masking is listed as none. General statistical principle: lack of masking can affect expectations, behavior, reporting, and assessment, depending on how outcomes are collected. The primary endpoint is an adverse-event measure, but the record does not report who determined whether an event met the endpoint definition or whether assessors were masked.

How should planning estimates be understood?

The registry's stated planning assumptions describe illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated effect to detect is a fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the study had a particular ability to detect a clinically meaningful effect. The record does not report the results of those calculations in the registry record for this analysis, nor does it report a sample-size justification from the study's own design.

General statistical principle: sample-size planning depends on assumptions about the outcome frequency or effect size, variability, error rates, allocation, and analysis method. A planning result is only as relevant as those assumptions. For rare binary outcomes, a normal approximation may be less reliable when expected event counts are sparse. The registry states that a normal approximation was used for the planning illustrations, but it does not report further details that would allow their assumptions to be assessed against the endpoint.

What is not available for statistical appraisal?

The registry reports 3 analyses but does not report their specific methods in the record summarized for this interpretation. The analysis population, handling of missing outcome data, treatment of withdrawals, and prespecified approach to multiplicity are not reported in the registry record. These choices affect what an estimate means. For example, an analysis based on participants as randomized has a different interpretation from one limited to participants who completed treatment; the record does not identify which approach was used.

General statistical principle: confidence intervals and hypothesis tests address sampling uncertainty under specified assumptions; they do not account automatically for every source of bias or uncertainty. Transparent reporting of the endpoint definition, analysis population, missing-data handling, and model helps readers judge whether those assumptions fit the study. For the primary outcome, the available result is a pair of descriptive percentages, with no reported interval or estimable comparison. That is the appropriate limit of the statistical interpretation.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 17 outcome measures and 11 posted secondary outcomes. It also reports 3 analyses. The specific analysis methods and the mapping between analyses and outcomes are not reported in the registry record. A multiplicity strategy—such as prioritizing a limited set of confirmatory comparisons or adjusting inference across multiple outcomes—is also not reported in the registry record.

General statistical principle: testing or estimating many outcomes can increase the chance that some results appear notable by chance, especially when each is interpreted as a separate confirmatory finding. This does not mean every secondary outcome requires the same adjustment; the appropriate approach depends on the study's aims and whether outcomes are exploratory or confirmatory. Without a reported analysis plan, readers cannot determine how the study intended to interpret the collection of outcomes together. The primary endpoint remains identifiable, but the broader secondary-outcome evidence cannot be assessed from outcome counts alone.

The registry record does not report a missing-data strategy, the number of participants with missing outcomes, reasons for missingness, or the analysis population used for the posted results. It does not report whether all randomized participants were analyzed according to assigned group or whether an alternative population was used. Missingness can matter because an outcome observed only for participants who remain in the study may not represent all enrolled participants if the likelihood of missing data is related to their condition or outcome.

These are reporting gaps rather than evidence that data were missing or that a particular analysis was performed. The primary arm values are reported, but no confidence interval or two-arm comparison is available. Consequently, the available record supports a descriptive reading of the primary outcome, while leaving the handling of missing observations and multiplicity unclear.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry safety figures report zero serious adverse events and zero deaths in each arm. For the virtual reality software arm, the record lists 15 participants at risk for serious adverse events and 0 affected; it also lists 15 at risk for other adverse events and 0 affected. For the traditional orientation methods arm, it likewise lists 15 at risk for serious adverse events and 0 affected, and 15 at risk for other adverse events and 0 affected. The listed death count is 0 in both groups.

These counts are consistent with the primary endpoint values of 0.0% in both arms, but serious adverse events and treatment-emergent adverse events are not necessarily identical categories. The primary endpoint is described as treatment-emergent adverse events; the safety figures separately report serious and other adverse-event counts. The registry does not report further event definitions or a list of serious event terms.

General statistical principle: zero observed events in a study does not establish that the true event risk is zero. Rare events may not occur in a study even when they remain possible in a broader population. The counts also do not provide a precise comparative safety estimate by themselves. No interval estimate or estimable two-arm comparison is reported for the primary count outcome.

The safety figures are therefore best read as a record of what was reported in these groups, not as proof that either approach is risk-free. The registry does not report additional detail about the method or duration of adverse-event surveillance beyond the primary endpoint's stated timeframe.

12. What the Result Does, and Does Not, Mean

The result establishes a narrow descriptive fact: the registry reports 0.0% for the primary treatment-emergent adverse-event endpoint in each arm. The safety counts also report no serious adverse events, other adverse events, or deaths in either group. These observations describe the results recorded for this study; they do not determine the event risk in a larger or different population.

The result does not show that ReCognitionVR and traditional orientation methods have equivalent safety. Equivalence requires a defined margin and an analysis designed to assess whether the comparative uncertainty lies within that margin. Neither an equivalence framework nor a comparative interval is reported in the registry record. The absence of an estimable two-arm comparison means the posted results do not quantify the difference between arms.

Nor does the primary endpoint show whether cognitive exercises were feasible or acceptable to participants. Those are stated aims, but details of their measurement and results are not reported in the record details. The endpoint also does not answer whether the approaches affect delirium, cognition, length of stay, or other clinical outcomes. Delirium and postoperative delirium are listed as conditions of interest, but that does not make them the primary endpoint.

The study's stated role was to inform a future study in critically ill hospitalized patients at risk for delirium. The primary results concern older surgical patients, so the registry does not establish how the same approach would perform in that future population or setting. Differences in population and care setting could matter, and the record does not provide evidence to quantify such differences.

Overall, the observed zero event counts are reassuring only in the limited descriptive sense that no such events were recorded in these study groups. They should not be converted into a claim of no risk or a claim that one approach is safer. The results are appropriately understood alongside the study's stated feasibility purpose and the lack of a reported comparative estimate, event-detail information, or uncertainty interval.

13. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the difference between an observed event frequency and a precise comparison. A zero percentage in each arm is straightforward to describe, but it does not supply an estimate of how much the underlying event risks differ. When the event count is zero in both groups, ordinary comparative summaries may be unavailable or unstable; the registry accordingly does not report an estimable two-arm effect for this count outcome.

The study also connects a safety-focused endpoint to a stated feasibility and acceptability aim. Such early-stage work can be useful for deciding what questions a later study should address, but descriptive safety results should not be mistaken for a definitive comparison of clinical effectiveness. The record explicitly says the findings were intended to inform a future study in critically ill hospitalized patients at risk for delirium.

The design features matter to interpretation. Randomized allocation can help limit baseline confounding, while an unmasked design can leave room for differences in behavior, reporting, or assessment. The registry identifies randomization and no masking but does not report sequence generation, concealment, or endpoint-assessment procedures. A statistical reader can recognize the intended design while noting that these implementation details are not available.

The registry lists multiple outcome measures and analyses but does not report a multiplicity strategy, analysis populations, or missing-data methods. Those details help distinguish exploratory patterns from confirmatory evidence and explain how reported results relate to all randomized participants. Their absence does not invalidate the posted descriptive outcome, but it limits assessment of the broader statistical plan.

Finally, planning illustrations and observed evidence answer different questions. The registry states assumptions for planning calculations, but such calculations are not observed power and do not increase the information in the actual outcome data. The central statistical lesson is to keep the conclusion aligned with the result: the study records no primary-endpoint events in either arm, while comparative precision and broader clinical implications remain unresolved in the registry record.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary outcome is reported as 0.0% in both arms, but the registry does not provide an estimable two-arm comparison or an uncertainty interval. This leaves the precision of any difference between approaches unquantified. With no observed events, the outcome is especially limited for assessing uncommon harms: a study may record no events without establishing that the underlying risk is absent.

The record does not provide a detailed definition of treatment-emergent adverse events, the process for attributing events to treatment, or the event-collection procedures. It also does not report the timing of the safety counts separately from the primary endpoint timeframe. These gaps make it difficult to determine exactly which events were eligible and how completely they were monitored.

The registry identifies the study as randomized and unmasked, but sequence generation, allocation concealment, and assessor masking are not reported in the registry record. The record also does not describe treatment adherence, withdrawals, or the analysis population. Missing-data procedures and reasons for any missing observations are not reported in the registry record, so the completeness of outcome assessment cannot be evaluated from the listed group values alone.

The study enrolled older surgical patients, while the stated future application concerns critically ill hospitalized patients at risk for delirium. The registry results therefore do not directly establish what would be observed in that different population and setting. The available information also does not provide detailed participant characteristics, making it difficult to judge the range of surgical patients represented.

Finally, feasibility and acceptability are central stated aims, but their measures and results are not reported in the record details used for this interpretation. The primary safety result alone cannot address those aims or establish effects on delirium or cognition. These limitations define what can be concluded from the posted results without implying that unreported procedures or outcomes were absent.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients — NCT06232317.
• Registry record last updated 2025-09-17; status last verified 2025-08.
• Results first posted 2025-09-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry describes a completed randomized, unmasked, parallel-group study of ReCognitionVR cognitive exercises versus traditional orientation methods in older surgical patients. Enrollment was 30, with 15 participants reported in each arm. The listed study dates are 2023-12-09 for the start and 2024-03-21 for primary completion.

The primary endpoint was the percentage of participants experiencing a treatment-emergent adverse event within 1 month of enrolling. The posted value was 0.0% in each arm. Safety figures also report zero serious adverse events, zero other adverse events, and zero deaths in each group. A two-arm comparison was not estimable for the primary count outcome, and no comparative uncertainty interval is reported.

The registry states that the study aimed to assess feasibility, acceptability, and safety and to inform a future study in critically ill hospitalized patients at risk for delirium. Details of the statistical plan, analysis populations, missing-data handling, and multiplicity approach are not reported in the registry record.