Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA (NCT05468398), a randomized na study. The primary outcome is Peak Pain Intensity During Genicular RFA Procedure.

2. Clinical Question

The study asks whether adding virtual reality during genicular nerve radiofrequency ablation is associated with different procedural pain and patient or provider experience than the procedure with local anesthetic alone. The main statistical question concerns the difference in mean peak pain intensity between randomized participants assigned to the VR intervention and those assigned to control.

The registry describes a randomized, parallel-group comparison. The posted primary outcome is a continuous score measured during the procedure, with a stated timeframe of 20 minutes. The comparison is about average scores across the two assigned groups, not whether every participant experienced the same effect. The record also lists outcomes concerning anxiety, provider experience, anesthetic use, prior experience, side effects, and time spent thinking about pain. Those measures add context about the procedure, but they do not replace the primary question about participants’ peak pain scores.

The registry record does not report the precise eligibility criteria or recruitment setting beyond describing adults receiving GNRFA. Details such as how randomization was carried out and whether allocation was concealed are not reported in the registry record. These omissions limit how fully the question’s target population and implementation can be assessed from the record alone.

3. Trial Design

The registry identifies this as a randomized, parallel-group study with no masking. The planned comparison assigned participants to a Control group receiving genicular RFA with local anesthetic as standard care or to a VR Intervention group receiving the same procedure and anesthetic care with the Soothe VR device. The record lists 40 participants enrolled. The posted primary analysis includes 20 participants in each group.

The trial status is completed. Its recorded start date is 2020-12-02, and its primary completion date is 2024-09-06. The phase is listed as not applicable. The sponsor is the University of California, Irvine. These registry entries describe the study’s administrative and design context; they do not establish how the procedure was delivered at each site or how participants experienced the device.

The primary outcome is peak pain intensity during the genicular RFA procedure. It is described as a Visual Analog Scale score ranging from 0 to 100, with higher scores indicating greater pain intensity. The primary analysis population is all randomized participants who reported peak pain intensity, with one measurement per participant. The registry reports 40 participants in that analysis.

There are several design details that cannot be reconstructed from the record. The method used to generate the random sequence, allocation concealment, recruitment procedures, and reasons for any missing outcome data are not reported in the registry record. Nor is the original sample-size justification or the trial’s complete statistical analysis plan reported in the registry record. The absence of masking is stated, but the record does not describe who knew each participant’s assignment or how that knowledge might have affected outcome measurement.

The registry lists 10 outcome measures and posts results for eight secondary outcomes. The secondary results include participant anxiety and provider assessments, among other topics. The posted summaries are useful for describing observed group averages, but the record does not report analyses for those secondary outcomes. That distinction matters: a randomized design supports a group comparison, while the strength of any conclusion still depends on outcome measurement, missingness, analysis choices, and precision.

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: Of the 40 participants who consented, all were randomized.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All randomized participants who reported peak pain intensity during the genicular RFA procedure were included in this analysis (n=40). Each participant contributed one measurement of peak procedural pain intensity.

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.

Population: All 40 participants (20 in the VR group, 20 in the control group) completed baseline surveys and were included in the baseline analysis. Each participant contributed one unit of analysis.

6. Primary Endpoint

The registry lists the primary outcome as Peak Pain Intensity During Genicular RFA Procedure, measured over 20 minutes.

The primary endpoint is peak pain intensity experienced during the genicular RFA procedure. Participants’ scores were measured with a Visual Analog Scale from 0, meaning no pain, to 100, meaning worst imaginable pain. The registry specifies a 20-minute timeframe and describes the result as a mean with standard deviation. Higher scores indicate greater pain intensity, so the direction of a group difference can be interpreted using that scale definition.

Peak intensity captures the highest reported pain during the procedure rather than an average across all moments or pain after the procedure. This makes it a focused measure of the most intense procedural experience, but it does not describe the duration of pain, changes over time, or later recovery. The registry indicates that each participant contributed one peak-pain measurement and that all randomized participants who reported the outcome were included.

A continuous score preserves more gradation than a simple yes-or-no outcome. Comparing group means provides a concise summary of the average scores, while the standard deviations describe how spread out individual scores were within each group. Neither summary indicates that all participants had scores near the group mean. The posted endpoint is therefore informative about average reported peak pain, but it does not by itself describe every aspect of pain or patient experience.

The registry record does not report further measurement details such as the exact scale administration procedure, the timing of the question relative to each participant’s peak, or any threshold defining a clinically important difference. The score can be interpreted in the stated direction, but the record does not establish how a particular difference should be judged clinically.

7. Results Posted in the Registry

• VR Intervention: mean 70.60 versus 75.80 on control; difference -5.20 (95% CI -18.80 to 8.40), standardized effect d = -0.24; z-test p = 0.454.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Patient Anxiety During Genicular RFA Procedure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • VR Intervention: mean 55.00 versus 67.50 on control; difference -12.50 (95% CI -28.23 to 3.23), standardized effect d = -0.49; z-test p = 0.119.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between VR Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Provider Satisfaction During Procedure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • VR Intervention: mean 91.70 versus 60.80 on control; difference 30.90 (95% CI 16.38 to 45.42), standardized effect d = 1.32; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for VR Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Provider Perception of Patient's Pain During Genicular RFA Procedure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • VR Intervention: mean 36.90 versus 70.80 on control; difference -33.90 (95% CI -49.74 to -18.06), standardized effect d = -1.33; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for VR Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes broaden the picture beyond participant-reported peak pain, but their pattern is not uniform. The posted anxiety comparison is uncertain, while provider satisfaction and provider perception of patient pain show clearer unadjusted differences between groups. These outcomes concern different reporters and aspects of the procedure, so they need not move in parallel with the primary pain score.

The secondary findings can provide context for interpreting the primary result. Provider ratings and satisfaction may reflect the procedural environment or provider experience, whereas the primary endpoint is the participant’s own peak pain score. A difference in a provider-reported measure does not establish a corresponding difference in participant-reported pain. Nor does it resolve the uncertainty in the primary confidence interval. The different outcomes should be considered as related but distinct measurements.

The registry lists 10 outcome measures, while results are posted for eight secondary outcomes. Results for the other listed outcomes are not reported in the registry record. The registry also reports no analyses in its analysis listing. The summaries therefore offer descriptive group comparisons, but the record does not clarify which secondary outcomes were prespecified for confirmatory testing, how many comparisons were considered in the analysis, or whether any adjustment for multiple testing was used.

When many outcomes are examined, some estimates may appear noteworthy by chance, even when there is no underlying group difference for those measures. This is why unadjusted secondary results carry less weight than a clearly prespecified primary analysis, especially when multiplicity handling is not reported. Their estimates and intervals remain useful for generating questions and characterizing the observed data, but should not be treated as independent confirmation of a primary result.

The secondary outcomes also have differing measurement targets and timeframes. Some concern the procedure itself, and others concern prior experience, side effects, or time spent thinking about pain. A broad list can be informative, but each measure needs its own interpretation. The posted summaries do not establish that the secondary outcomes all represent one common underlying effect, and they should not be combined into a single overall conclusion.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Patient Anxiety During Genicular RFA Procedure
• Provider Satisfaction During Procedure
• Use of Additional Local Anesthetic During Genicular RFA Procedure
• Provider Perception of Patient's Pain During Genicular RFA Procedure
• Prior Knee Radiofrequency Ablation
• Prior Experience With Virtual Reality (VR)
• Side Effects Associated With Virtual Reality During Genicular RFA Procedure
• Duration of Time Spent Thinking About Pain During Genicular RFA Procedure

9. Statistical Interpretation

10. Statistical Methods Explained

The main endpoint is continuous: each participant contributed a score on the Visual Analog Scale, and the posted summaries use means and standard deviations. A mean represents the group’s average score. A standard deviation describes how much scores vary around that average. These summaries are useful for comparing average values, but they do not show the full distribution or whether a small number of scores strongly influenced the mean.

What does the mean difference represent?

The reported contrast is the VR Intervention group mean minus the Control group mean. Its estimate is -5.2 points. Since larger scores indicate worse pain intensity, a negative estimate means the observed average was lower in the VR group. This is a description of the group averages, not a statement that every participant’s score changed by that amount. It is also not an adjusted estimate: the registry does not report a covariate-adjusted primary analysis.

A mean difference is measured in the original scale’s units, making it directly interpretable against the score range. The registry does not report a threshold for a clinically important difference. Statistical estimation can describe the size and uncertainty of a contrast, but clinical importance requires context not established by the posted summaries.

How should the confidence interval be understood?

A confidence interval describes uncertainty in an estimated group difference under the statistical method’s assumptions. The primary interval runs from -18.8 to 8.405. Its inclusion of zero means that a zero difference is compatible with the interval; its extension to both negative and positive values also permits differences in either direction. The interval should be considered alongside the point estimate rather than as a guarantee that the true difference falls within its endpoints.

The primary p-value is unadjusted and equals 0.454. A p-value summarizes how unusual data at least as incompatible with a null model would be if that model and the test assumptions held. It is not a measure of effect size and is not the probability that a finding is due to chance. A p-value above a conventional threshold does not establish equality, absence of an effect, or equivalence.

Why do dispersion and sample size matter?

Individual scores vary, and the posted standard deviations are 21.9 in Control and 22.0 in VR Intervention. Greater within-group variability makes it harder to estimate a group mean difference precisely for a given number of participants. Increasing the amount of information can improve precision, but the registry result itself remains the estimate from the participants analyzed; a planning calculation cannot change the uncertainty in that observed result.

The primary analysis includes 40 participants who reported peak pain, with 20 in each group. The registry describes these as all randomized participants who reported the outcome and states that each contributed one measurement. It does not report whether all randomized participants provided every secondary outcome, why data might be missing, or how missing values were handled beyond the stated primary analysis population.

What is and is not known about the analysis?

The registry identifies random allocation, parallel groups, and no masking. It does not report the randomization sequence method, allocation concealment, a full analysis plan, or whether any interim analyses were planned. The original sample-size calculation and its assumptions are not reported in the registry record. The planning illustrations associated with the posted results are based on the observed effect and stated assumptions; they are not evidence of what informed the original design.

The primary comparison is an unadjusted mean difference with a confidence interval and unadjusted p-value. The record does not report whether the analysis used a particular parametric test, whether assumptions were checked, or whether any sensitivity analyses were conducted. The arithmetic summaries can be interpreted as reported, but further details about the inferential procedure are not reported in the registry record.

Why does over-dispersion matter in general?

In general, over-dispersion means that observed variability is greater than a statistical model expects. When a model understates variability, its uncertainty estimates can be too small and its intervals too narrow. The posted primary outcome is a continuous score summarized by means and standard deviations, and the registry record does not report an over-dispersion assessment. This general issue should not be mistaken for a finding that over-dispersion occurred in this study.

For continuous outcomes, distribution shape and influential observations can also affect how well a mean-based model describes the data. The registry record does not post individual participant scores or diagnostic checks, so the shape of the score distributions cannot be assessed from the summary values alone. The standard deviations offer information about spread, but they are not a substitute for participant-level data or model diagnostics.

How should the secondary analyses be treated?

The record posts results for secondary outcomes but reports no analyses in its analysis listing. The available comparisons are unadjusted. If multiple outcomes are examined, the chance of at least one apparently unusual result can increase, depending on how many tests are conducted and how they are related. No multiplicity strategy is reported in the registry record. Accordingly, secondary p-values should be read as exploratory evidence, not as automatically confirmatory tests.

These methods explain why the primary result should be read through its estimate, interval, scale direction, and analysis population together. None of those elements alone provides a complete account. The registry record supplies useful descriptive and comparative statistics, while key details about the statistical plan and data handling remain unreported.

11. Confidence Intervals and Precision

The primary mean difference is -5.2, with a confidence interval from -18.8 to 8.405. The interval is the main summary of precision: it shows that the point estimate is uncertain and that the posted data are compatible with values on either side of zero. It should not be reduced to a binary conclusion based only on whether the interval crosses zero.

In general, a confidence interval gives a range of estimates that are reasonably compatible with the data and the method’s assumptions at the stated confidence level. The registry record does not specify the confidence level in the outcome description. The interval’s width reflects the information available and variability in the observed scores; it does not mean that every value in the interval is equally likely.

The group standard deviations, 21.9 and 22.0, indicate that individual scores varied within both arms. The analysis includes 20 participants per arm. Given that amount of data and the observed spread, the interval leaves uncertainty about both the direction and size of the average difference. No conclusion of equivalence follows from the interval including zero; an equivalence assessment would require a prespecified margin and an analysis designed for that question, neither of which is reported in the registry record.

The unadjusted p-value of 0.454 is consistent with the interval’s failure to rule out zero, but it is not a substitute for considering the interval endpoints. The point estimate may be the best single summary of the observed contrast, yet the interval makes clear that it should not be treated as precise. The registry record does not report a clinically important difference threshold, so the clinical meaning of the interval’s values cannot be classified using a registry-defined benchmark.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations are planning calculations based on the observed effect, not the trial’s original design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The calculations consider detecting the stated fraction of the observed effect. The original design assumptions and sample-size justification are not reported in the registry record.

These figures are participants per arm, not total participants and not total events. The 80% power column represents the planned number of participants per arm for a design that would have an 80% chance of detecting the assumed effect under the listed assumptions, if that effect and model were correct. The 90% power column makes the same kind of illustration for a 90% chance. Neither column describes the probability that the observed result is true.

The rows use 100%, 75%, and 50% of the observed effect. A smaller assumed effect requires more participants per arm to detect at the same target power and significance level. For example, the primary-outcome illustration gives 280 participants per arm for 80% power at 100% of the observed effect, and 1,119 participants per arm for 80% power at 50% of the observed effect. The corresponding 90% figures are 375 and 1,498 participants per arm.

These are planning illustrations, not observed power. They are sensitive to the assumed effect size and the stated statistical assumptions. The observed effect comes from a small study and may not be a stable estimate for future planning. The illustrations should not be read as a recommendation for a future trial’s size or as evidence that the current study did or did not have adequate power under its original design.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -5.200; pooled standard deviation σ = 21.950.
2. n = 2 × (1.96 + 0.842)² × 21.950² / -5.200² = 279.7, rounded up to 280 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -5.2                      # observed difference in means
sigma <- 21.9500569475343                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5468398)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 280 (80% power), 375 (90% power)
 75% of observed effect: n per arm = 498 (80% power), 666 (90% power)
 50% of observed effect: n per arm = 1,119 (80% power), 1,498 (90% power)
power.t.test: 280.7 
Simulated power at n = 280 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry reports 10 outcome measures and posts results for eight secondary outcomes. It lists 0 reported analyses. The record does not describe a multiplicity adjustment, a hierarchy for testing outcomes, or which secondary comparisons were intended as confirmatory. Without those details, the unadjusted secondary p-values should be interpreted cautiously. Examining multiple outcomes can increase the opportunity for apparently strong results that are not replicated, although the amount of that risk depends on the number and dependence of tests.

The primary comparison is reported with an unadjusted p-value. Whether the primary analysis was intended to stand alone or was part of a broader testing strategy is not reported in the registry record. No statistical analysis plan is available in the record to establish a prespecified ordering or a family of outcomes for error control. The observed secondary patterns are therefore descriptive and exploratory unless additional planning information exists outside the registry record.

For the primary endpoint, the stated analysis population consists of all randomized participants who reported peak pain, with 40 participants included and one measurement per participant. This tells the reader who contributed to that outcome summary. It does not explain whether any participants were randomized but did not report the outcome, whether the outcome data were complete for every randomized participant, or why data might be missing. The registry record does not describe an imputation method or a sensitivity analysis for missing primary data.

Group summaries show 20 participants in each arm for the primary and posted secondary results. The record does not give further details about missingness or the analysis populations for each secondary endpoint. It is therefore not possible to determine from the posted summaries whether every randomized participant contributed to every secondary outcome or whether the same analysis population was used across all outcomes.

The registry does not report an interim-analysis plan, stopping rules, or a full account of outcome selection and analysis decisions. Those omissions do not prove that such procedures were absent; they mean the registry record does not document them. Taken together, incomplete multiplicity and missing-data information limits how strongly secondary results can be interpreted and makes the stated primary analysis population especially important.

15. 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 posted serious adverse event figures report 0 affected participants in the Control group among 20 at risk and 0 in the VR Intervention group among 20 at risk. The posted figures also show 0 participants with other adverse events in each group, with 20 at risk per group. Deaths are reported as 0 in both groups, and no serious adverse event terms are listed.

These are counts in the registry record, not estimates proving that an event cannot occur. They describe what was reported for the listed groups and denominators. With no affected participants recorded, a comparative risk estimate is not available from these figures. The data also do not establish the completeness or duration of adverse-event monitoring.

The registry separately lists side effects associated with virtual reality during the procedure as a secondary outcome, but the safety counts alone do not provide detail about the nature, severity, timing, or ascertainment of potential symptoms. Those details are not reported in the registry record. The zero counts should therefore be read as the posted event counts for this study, not as a general claim about safety in other procedures, populations, or settings.

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

The posted results describe mean peak procedural pain scores that were lower in the VR Intervention group than in the Control group. The estimated mean difference is -5.2 points on a scale where higher scores indicate greater pain intensity. The confidence interval, from -18.8 to 8.405, includes zero and allows for differences in either direction. The result is therefore uncertain in both size and direction, despite the negative point estimate.

The primary comparison does not demonstrate equivalence between the groups. It also does not provide strong statistical evidence of a difference under the unadjusted analysis. Those statements are not contradictory: the study can have an estimate favoring one group while the uncertainty remains too large to rule out other plausible values. The record does not provide an equivalence margin or a clinically important difference threshold with which to interpret the magnitude.

The endpoint captures participants’ peak pain during the procedure, rather than pain over a longer period or a complete account of their experience. The secondary measures add information about anxiety and provider perspectives, among other outcomes, but they are distinct and include unadjusted comparisons. Their presence does not eliminate uncertainty in the primary result.

The study enrolled 40 participants, and the primary analysis included 20 per group. A result from this study should not automatically be generalized to people outside the described population, other procedures, different VR devices, or different care settings. Details about eligibility, recruitment, the randomization procedure, missing data, and the original statistical plan are not reported in the registry record, limiting assessment of applicability and robustness.

The registry results are best understood as a small randomized comparison with a negative primary point estimate and an interval that remains compatible with both lower and higher mean scores in the VR group. The posted data describe what was observed; they do not by themselves establish a definitive effect, no effect, or a clinical recommendation.

17. Why This Trial Matters Statistically

This study illustrates an important statistical distinction between the direction of an estimate and the certainty of that estimate. The primary point estimate is negative, indicating a lower observed average pain score in the VR group, but its confidence interval includes zero and extends in both directions. Reporting the estimate together with its interval avoids treating a single number or a p-value as the whole result.

The endpoint also highlights how outcome choice shapes interpretation. Peak pain is a direct participant-reported measure of a specific moment in a procedure. Provider satisfaction and provider perception of pain address different perspectives. A study can show a more distinct contrast on one of those measures while leaving the primary participant-reported endpoint uncertain. Statistical interpretation requires keeping each outcome tied to its reporter and meaning.

The trial’s size is relevant to precision, but the registry’s planning illustrations must not be mistaken for its original design justification. The record does not report why the enrolled sample size was selected. The observed-effect calculations demonstrate how sample-size requirements change when planning around smaller effects, but they do not establish what the original study could reliably detect or whether its design assumptions were met.

The registry also shows why the reporting of analysis plans, missingness, and multiplicity matters. Without those details, readers have less ability to distinguish planned confirmatory questions from exploratory comparisons or to assess the effect of incomplete data. Those are not merely administrative details; they shape the strength of inference that can be drawn from observed estimates.

For biostatisticians and clinical researchers, the central lesson is to read design, population, outcome definition, effect estimate, interval, and analysis transparency together. That approach preserves the useful information in the posted results while avoiding stronger conclusions than the record supports.

18. 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 registry does not report the method used to generate the random allocation sequence or whether allocation was concealed. It identifies the study as unmasked, but does not specify who knew assignment or how outcome collection was managed. Because the primary endpoint is participant-reported and other outcomes include provider ratings, the absence of those implementation details limits assessment of potential measurement influences.

The enrollment is 40, and the primary outcome analysis includes 20 participants per group. The primary confidence interval is broad and includes values in both directions. The registry does not report the original sample-size justification, so it is not possible to assess the planned detectable effect or whether the study’s design assumptions were appropriate for its primary question.

The registry record does not describe eligibility criteria in detail, recruitment methods, or the settings in which procedures took place. This makes it difficult to assess how representative the participants were of other adults receiving GNRFA. Results involving the Soothe VR device should not be assumed to apply to other devices or implementations, which are not described in this trial record.

Missing-data information is limited. The primary population is defined as randomized participants who reported peak pain, but the record does not explain whether any randomized participants lacked that measure or why. It does not report the missing-data approach or sensitivity analyses. Comparable population details are not reported for each secondary outcome.

The record posts multiple secondary results without reporting a multiplicity strategy or a complete statistical analysis plan. Their unadjusted comparisons are therefore less secure as confirmatory findings. The registry also does not report detailed scale properties or a clinically important difference threshold. These limitations constrain interpretation of both the clinical relevance and robustness of the posted statistical results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA — NCT05468398.
• Registry record last updated 2026-05-22; status last verified 2026-05.
• Results first posted 2025-07-04.
• 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.

22. Record Summary

The registry record describes a completed randomized, parallel-group study of virtual reality during genicular nerve radiofrequency ablation. Forty participants were enrolled. The Control group received the procedure with local anesthetic as standard care; the VR Intervention group received that care with the Soothe VR device. The study was unmasked.

The primary outcome was peak pain intensity during the procedure, measured on a Visual Analog Scale from 0 to 100. The mean was 75.8 in Control and 70.6 in VR Intervention. The posted mean difference was -5.2, with a confidence interval from -18.8 to 8.405 and an unadjusted p-value of 0.454. The estimate favors a lower mean score in the VR group, while the interval leaves substantial uncertainty.

The registry posts eight secondary outcomes and reports 0 analyses in its analysis listing. Serious adverse events, other adverse events, and deaths are recorded as 0 in both groups. The original sample-size justification, full statistical plan, multiplicity approach, and detailed missing-data handling are not reported in the registry record.