This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluating the Feasibility of VR for Pediatric Renal Biopsies (NCT05267704), a na na study. The primary outcome is Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05267704 |
| Phase | NA |
| Condition | Pain, Procedural, Procedural Anxiety, Sedation Complication |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, San Francisco |
| Results posted | Yes |
2. Clinical Question
Population
Pediatric patients described in the VR arm as age 5-17 and undergoing renal biopsy. The registry lists enrollment of 32.
Intervention
Use of an Oculus Go Virtual Reality Headset during renal biopsy. The study purpose was to assess VR as an adjunct or alternative to pharmacologic sedation.
Comparator
No separate comparator arm is listed. The record describes a single-group study, with allocation listed as NA, so it does not support a like-for-like treatment comparison.
Primary question
How many participants strongly agreed that they would recommend VR to others undergoing similar procedures? The registry record describes this as an acceptability measure; it does not report the numerical result.
The clinical question concerns the feasibility and acceptability of using VR during a pediatric renal biopsy, not a randomized comparison of VR against another approach. The registry describes the headset as an adjunct or alternative to pharmacologic sedation, but the listed intervention does not establish whether VR replaced medication, accompanied it, or was used under a consistent sedation protocol. Those details are not reported in the registry record.
The primary measure asks about willingness to recommend VR after the procedure. That is a patient-reported judgment about the experience, rather than a direct measurement of pain, anxiety, sedation, or procedural success. The record also lists changes in self-reported procedural anxiety measured with the Childhood Anxiety Meter and Child Fear Scale. These measures address related but distinct questions: whether anxiety scores changed and whether participants or parents found VR acceptable. The registry record does not report the numerical results for these outcomes, so their direction and precision cannot be assessed.
3. Trial Design
The registry describes a completed, single-group study with enrollment of 32. Its listed intervention was an Oculus Go Virtual Reality Headset, and the arm description identifies pediatric patients age 5-17 using the headset during renal biopsy. The registry lists allocation as NA and masking as NONE. It does not list a separate comparison arm, so the design cannot estimate a randomized between-group contrast.
The study’s stated purpose was to assess VR as an adjunct or alternative to pharmacologic sedation in pediatric patients undergoing renal biopsy. The registry lists the start date as 2022-10-11, primary completion as 2024-09-08, and status as COMPLETED. Phase is listed as NA. These registry fields describe the study record; they do not establish how procedures were conducted or whether all enrolled participants contributed data to every outcome.
The primary outcome is a count: participants who strongly agreed that they would recommend VR to others undergoing similar procedures. Acceptability was assessed using a team-made Likert scale survey given to patients and parents. The stated timeframe runs from arrival to the procedural room to completion of the procedure, about 30 minutes. The record also lists two secondary anxiety outcomes based on changes in the Childhood Anxiety Meter and Child Fear Scale.
Although the record lists four outcome measures and two analyses, it does not report the statistical methods used for those analyses, the analysis populations, or the handling of missing observations. The registry record does not report a protocol-level sample-size justification, an interim-analysis plan, or a detailed sedation regimen. Consequently, the design supports a description of the planned single-group evaluation, but not a full reconstruction of the conduct or analysis.
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.
Before assignment: Pediatric patients aged 5 to 17 years were the enrolled participants, as they were the only individuals who engaged with the virtual reality (VR) environment during renal biopsies. Caregivers provided informed consent for their child's participation, and assent was obtained from the child when appropriate. Caregivers and sedation providers completed brief surveys about their perceptions of the VR experience but were not themselves enrolled in the study.
Overall Study
| Stage | VR Arm |
|---|---|
| STARTED | 32 |
| COMPLETED | 32 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | VR Arm |
|---|---|---|
| Participants analysed | 32 | |
| Age, Categorical: <=18 years | Participants | 32 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 15 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures, measured over From arrival to procedural room to completion of procedure (~30 minutes).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants (patients) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of participants who strongly agreed that they would recommend VR to others undergoing similar procedures. It represents acceptability: whether the experience was viewed favorably enough for a participant to endorse it to someone facing a similar procedure. The registry says acceptability was assessed with a team-made Likert scale survey given to patients and parents. Its response scale runs from 1 = strongly disagree, described as most dissatisfied with the VR experience, to 5 = strongly agree, described as most satisfied and as a better perceived outcome.
A recommendation question can be useful in a feasibility study because it captures an aspect of the participant experience that may affect willingness to use an approach again. It is not, by itself, a measure of clinical benefit or a direct measure of anxiety, pain, sedation adequacy, or safety. Nor does the count indicate how strongly other survey responses were distributed across the scale.
The stated timeframe spans arrival to the procedural room through completion of the procedure, about 30 minutes. The numerical count for this primary endpoint is not reported in the registry record. The record also does not report the number of responses available, the distribution across Likert categories, or an uncertainty interval for the count. Those omissions prevent assessment of the observed level of acceptability and its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a patient-centered primary outcome, but its numerical result is not reported in the registry record. As a result, the central acceptability question cannot be answered from the posted results available in this record: the number who strongly agreed that they would recommend VR is unknown. No proportion, comparison, or estimate of uncertainty should be inferred from the enrollment figure alone.
The study is described as single-group, with allocation listed as NA and no masking. There is no separate control arm listed. This means the record does not provide a randomized estimate of how outcomes under VR compare with outcomes under another sedation approach or usual care. Even if a favorable patient response had been reported, it would describe responses in this group and would not, by itself, isolate an effect attributable to VR.
The secondary outcomes concern changes in self-reported procedural anxiety on the Childhood Anxiety Meter and Child Fear Scale. The record names these measures but does not report their numerical results, the timing of each assessment, or the analytical approach. It is therefore not possible to describe whether scores changed, in which direction, or with what precision. The record’s listing of four outcome measures and two analyses does not fill that gap: the actual outcome estimates and their uncertainty are not reported.
For a count endpoint, the number of positive responses would describe how many participants met the stated response category. Its interpretation depends on knowing how many participants posted an evaluable response and how the survey was administered. Those details, as well as an interval estimate, are not reported in the registry record. General statistical interpretation would consider both the count and its denominator; the enrollment of 32 is not a substitute for a reported endpoint denominator.
The adverse-event figures are reported separately: the VR arm lists 32 at risk, 0 affected by serious events, 0 affected by other events, and 0 deaths. These are the posted counts for the listed categories. They should not be read as proof that the risk of an event is absent, particularly because the record does not describe event ascertainment, follow-up completeness, or the precision of the estimates.
Overall, the registry supports a description of the intended feasibility and acceptability assessment and of the reported safety counts. It does not provide enough outcome information to estimate acceptability, anxiety change, or comparative effects. Statistical conclusions about benefit, equivalence, or the likelihood of future outcomes would go beyond what the registry record reports.
9. Statistical Methods Explained
The registry identifies the outcome types and design features, but it does not report the statistical procedures used to analyze the outcomes. The explanations below describe general statistical concepts relevant to interpreting this kind of study; they are not claims about methods used by the investigators.
What does a count endpoint describe?
The primary endpoint is a count of participants selecting the strongest agreement response to a recommendation question. A count conveys the number meeting that stated criterion. Its interpretation usually depends on the number of participants who were eligible to answer and the number with an observed response. The registry lists enrollment of 32, but does not report the evaluable denominator for this endpoint. Enrollment and outcome completion are not interchangeable, so the enrollment figure cannot establish the response rate or the fraction who strongly agreed.
Because the outcome is based on a Likert response, reducing the scale to the strongest-agreement category focuses on a particular threshold. That can make the endpoint easy to describe, but it does not preserve the full response distribution. Responses in other categories may differ in degree, and the count alone cannot reveal that pattern. The registry does not report category-level responses or explain how missing survey answers were handled.
Why does the single-group design matter?
In a single-group study, outcomes describe the participants observed under the study approach. A control group can help distinguish an intervention-related difference from other influences, such as the procedure itself, expectations, or changes over time. Without a separate comparator, this record cannot estimate a between-group treatment contrast. The allocation field is NA, and the record’s design is single-group; it is not a randomized comparison.
Masking is listed as NONE. In general, a participant’s knowledge of the experience being evaluated can influence subjective reports, particularly ratings of anxiety or satisfaction. This does not establish that any response was biased, but it is relevant when interpreting self-reported measures. The record does not describe additional steps used to reduce response or assessment bias.
What would an uncertainty interval add?
In general, a confidence interval gives a range of values reasonably compatible with the observed data under a specified statistical model. It conveys precision as well as the point estimate. A count or percentage without an uncertainty interval can be difficult to generalize beyond the observed participants, especially when the number of responses is limited. The registry record does not report an interval for the primary endpoint or numerical estimates for the secondary anxiety outcomes. No precision estimate can therefore be interpreted from this record.
For counts, analysts may use methods appropriate to the outcome’s distribution and the study design. General count models can require attention to over-dispersion, which occurs when variability exceeds what a chosen model expects. Ignoring it can make standard errors too small and intervals too narrow. However, the registry does not identify a count model, report a variance estimate, or provide enough outcome data to determine whether over-dispersion is relevant. It would be inappropriate to claim that a particular model was used or required.
How should the anxiety outcomes be considered?
The listed secondary outcomes are mean differences in self-reported procedural anxiety changes on the Childhood Anxiety Meter and Child Fear Scale. A mean difference summarizes an average change or contrast, but its meaning depends on the measurement schedule, score direction, calculation of change, and analysis population. These details and the actual estimates are not reported in the registry record. Without them, the labels alone do not establish whether anxiety increased or decreased, or whether any observed change was precise.
When repeated measurements are used, general analysis choices include whether to compare each participant’s change, compare scores at a particular time, or model measurements over time. These approaches answer related but not identical questions. The registry record does not say which approach was used. It also does not report whether the analysis accounted for repeated observations or how incomplete measurement pairs were treated.
What can planning calculations say?
General sample-size calculations can illustrate the number of participants per arm needed to detect a specified effect under stated assumptions. The planning assumptions described for this study’s illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect framed as a stated fraction of an observed effect. Such calculations are planning illustrations, not observed power and not evidence that a study had a particular probability of detecting an effect after it was conducted. The registry record does not report the trial’s own sample-size justification. Since this study is listed as single-group and no numerical outcome estimate is reported, the planning assumptions should not be treated as a randomized comparison or as a result of the trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures and two analyses. It names a primary recommendation endpoint and two secondary anxiety outcomes based on changes in the Childhood Anxiety Meter and Child Fear Scale. The additional outcome measures and the relationship between the listed analyses are not described in enough detail to reconstruct a complete analysis plan.
When a study examines several outcomes or performs multiple statistical tests, the chance of finding at least one apparently notable result can increase. General methods for addressing this include prioritizing a prespecified primary outcome or adjusting inference across tests. The registry record does not report whether any multiplicity strategy was planned or used, so it is not possible to determine how the analyses were interpreted in relation to one another.
Missing-data methods are also not reported. The record does not state how many participants completed each survey, whether any responses were missing, whether participants were excluded from particular analyses, or whether missing values were imputed. It does not identify an intention-to-treat, per-protocol, or other analysis population. Enrollment of 32 and the safety count of 32 at risk do not establish the denominator for each patient-reported outcome.
These omissions matter because survey completion and analysis choices can affect the interpretation of both the recommendation count and anxiety changes. The registry record does not provide enough information to assess whether missing observations could have altered the results or whether all enrolled participants were included in each analysis. Accordingly, conclusions about completeness, multiplicity-adjusted inference, and representativeness of the analyzed group are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| VR Arm | 0 | 32 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| VR Arm | 0 of 32 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| VR Arm | 0 of 32 |
The registry lists the VR arm with 32 participants at risk. It reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These are the counts recorded for the listed safety categories.
A zero count means that no affected participants are recorded for that category in the registry entry; it does not establish that the underlying risk is zero. The interpretation of safety counts depends on how events were defined, sought, classified, and followed. The registry record does not report those procedures, the duration or completeness of safety follow-up, or an uncertainty interval for the counts.
The figures are descriptive and come from a single-group study. They do not provide a comparison with another sedation approach, and they cannot establish that VR caused or prevented an event. The record also does not list serious-event terms. The posted counts should therefore be read narrowly as reported events in the listed arm, not as a comprehensive estimate of comparative safety.
12. What the Result Does, and Does Not, Mean
The registry describes a completed feasibility study evaluating VR during pediatric renal biopsy, with acceptability as the primary outcome and self-reported anxiety measures among the secondary outcomes. Its single-group design is relevant: the record does not include a comparator arm or a randomized estimate of outcomes under an alternative approach.
The primary endpoint’s numerical result is not reported in the registry record. The record therefore does not show how many participants strongly agreed that they would recommend VR. It also does not report numerical results for the two named anxiety-change outcomes. Without those results, readers cannot determine the observed level of acceptability, the direction of anxiety changes, or the precision of either outcome.
The safety entry reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 32 at risk in the VR arm. These counts describe what the registry records; they do not show that risk is absent or permit comparison with another approach.
The study’s stated purpose and outcomes make it relevant to questions about participant experience and the feasibility of incorporating VR into this procedural setting. However, the registry record does not establish that VR reduced anxiety, replaced pharmacologic sedation, improved procedural outcomes, or was superior to another approach. It does not report the sedation regimen, outcome estimates, or enough analysis detail to support those conclusions. The appropriate interpretation is limited to the study design, outcome definitions, and posted safety counts, while recognizing that the principal numerical results are not reported.
13. Why This Trial Matters Statistically
This study raises statistical issues common to feasibility research: the distinction between describing an experience and estimating a comparative effect, the handling of subjective outcomes, and the need to report denominators and uncertainty. Its primary endpoint is a recommendation response rather than a direct measure of procedural success. That makes the endpoint informative about acceptability, but it cannot stand in for anxiety, pain, sedation adequacy, or clinical effectiveness.
The single-group design places a clear boundary around inference. Without a separate comparator, the study cannot isolate outcomes attributable to VR from the wider procedural experience. The lack of masking is also relevant to interpretation of self-reported outcomes, though it does not prove that responses were biased.
Clear outcome reporting is especially important for a count endpoint. Readers need the observed count, the number with evaluable responses, and a measure of uncertainty to understand both the result and its precision. The registry record does not report the primary count or the numerical secondary results. Its safety counts are available, but without information about event ascertainment or follow-up they remain descriptive.
These limitations do not erase the study’s value as a documented evaluation of an approach in a specific procedural setting. They do mean that statistical conclusions must stay close to what is reported. The record identifies a feasibility question and relevant patient-reported outcomes, but it does not provide the estimates needed to judge their observed results or compare VR with another strategy.
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 main limitation for interpretation is that the numerical result for the primary recommendation endpoint is not reported in the registry record. Numerical results for the named anxiety outcomes are also not reported. Without these estimates, the direction, magnitude, and precision of the patient-reported findings cannot be assessed.
The single-group design has no listed comparator arm, and allocation is recorded as NA. Masking is listed as NONE. Consequently, the record cannot support a randomized comparison, and subjective responses may be influenced by participants’ awareness of the VR experience. This is a design consideration, not evidence that any particular response was affected.
The registry does not report the evaluable denominator for each outcome, the distribution of Likert responses, missing-data procedures, analysis populations, or statistical models. It also does not report a detailed sedation regimen, survey administration procedures beyond the stated patient-and-parent survey, or the protocol-level sample-size justification. These gaps limit evaluation of measurement, analysis, and generalizability.
The listed safety counts are limited to the registry’s categories and do not include reported serious-event terms. Event definitions, ascertainment, follow-up completeness, and uncertainty estimates are not reported. Finally, the study concerns pediatric renal biopsy patients described as age 5-17; the record does not establish applicability to other populations or procedures. These limitations restrict interpretation to the listed study setting and recorded data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluating the Feasibility of VR for Pediatric Renal Biopsies — NCT05267704.
- Registry record last updated 2026-03-12; status last verified 2026-03.
- Results first posted 2026-03-12.
- 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.
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18. Record Summary
The registry describes NCT05267704, titled Evaluating the Feasibility of VR for Pediatric Renal Biopsies. It is a completed, single-group study with enrollment of 32, evaluating an Oculus Go Virtual Reality Headset during pediatric renal biopsy. The listed arm describes patients age 5-17. Allocation is NA, masking is NONE, and phase is NA.
The primary outcome counts participants who strongly agreed they would recommend VR to others undergoing similar procedures. The record also names anxiety-change outcomes using the Childhood Anxiety Meter and Child Fear Scale. The numerical results for the primary and secondary outcomes are not reported in the registry record.
The VR arm lists 32 at risk, 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. The record does not report a separate comparator, detailed analysis methods, or missing-data procedures.