Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population (NCT06101264), a non-randomized na study. The primary outcome is Average Change in Subjective Pain Level Using a 10 Point Likert Scale.

2. Clinical Question

The study asks whether a post-operative virtual reality intervention is associated with changes in pain reported around physical therapy sessions, opioid administration during the inpatient post-operative period, and the number of physical therapy sessions before clearance. The primary outcome is the average change in subjective pain before and after physical therapy sessions. The registry also lists opioid use and physical therapy sessions before clearance as secondary outcomes.

These questions concern outcomes during recovery in the hospital, rather than a long-term outcome. The record states that pain is assessed before and after each physical therapy session and that the within-session change is averaged across each patient. It does not establish whether observed differences, if any, would be attributable to virtual reality: the non-randomized allocation leaves open the possibility that the arms differ in other ways.

3. Trial Design

The registry identifies NCT06101264 as a completed, parallel, non-randomized study sponsored by Connecticut Children's Medical Center. Enrollment is recorded as 20. The listed phase is NA, allocation is non-randomized, and masking is none. The study compares a virtual reality intervention arm with a control arm that does not receive virtual reality following corrective surgery for idiopathic scoliosis.

The recorded start date is 2024-01-01, and the primary completion date is 2025-06-01. The study status is completed. These administrative details establish the registry's recorded timeline and status, but they do not provide the final number analyzed for each outcome or establish that every enrolled participant contributed data to every analysis.

The study's stated purpose is to assess subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy. The primary endpoint is a mean of a continuous measure: average change in subjective pain level using a 10 point Likert scale. Secondary outcomes are total amount of administered opioids during the post-operative period and average number of physical therapy sessions before clearance by physical therapy staff.

Because allocation was not randomized and masking was absent, interpretation must account for possible differences between the arms and for the possibility that participants or staff knew which intervention was received. The registry record does not describe how allocation was decided, whether the arms were matched or adjusted for baseline characteristics, or the statistical plan used to compare them. It also does not report an analysis population, final arm-specific counts, or outcome results.

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 Average Change in Subjective Pain Level Using a 10 Point Likert Scale, measured over 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively).

The primary endpoint is the average change in subjective pain level using a 10 point Likert scale. The scale runs from 0, described as no pain, to 10, described as the worst possible pain. Pain is assessed before and after every physical therapy session, and the before-to-after change is calculated and averaged across each patient. The timeframe is twice daily postoperatively until hospital discharge, up to 60 days postoperatively.

This endpoint focuses on pain in connection with physical therapy, rather than a single measurement at a fixed post-operative moment. Taking a within-session change can describe whether reported pain differs after a session compared with before it. Averaging those changes across a patient is intended to summarize that person's experience across sessions. These are general features of a repeated-measure pain summary; they do not establish how the endpoint was analyzed in this study.

The measure is relevant to the stated study purpose because subjective pain is one of the recovery outcomes the study seeks to assess. Its interpretation depends on how the change is defined, the number and timing of sessions contributing to each patient's average, and whether all patients have comparable observations. Those details and the resulting endpoint values are not reported in the registry record. No group means, standard deviations, between-arm estimate, or confidence interval is reported, so the magnitude and precision of any observed difference cannot be evaluated from the registry results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods determine how outcomes are summarized and how uncertainty in comparisons is assessed. The registry identifies the primary measure as a continuous outcome summarized by a mean, with standard deviation as the stated dispersion. It does not report the analysis method actually used, an estimated effect, or any inferential result. The concepts below are general explanations of what the stated outcome and common statistical summaries mean; they should not be read as a description of an unreported analysis.

What does a mean summarize?

In general, a mean is an average of observed values. Here, each patient's pain summary is described as an average of changes measured before and after physical therapy sessions. A group mean would then summarize those patient-level values for an arm. The mean can be informative, but it may not describe every participant's experience. Its interpretation also depends on which observations entered the calculation and how the change was defined. The registry does not report the resulting means or the number of sessions contributing to them.

What does the standard deviation describe?

In general, a standard deviation describes how spread out observations are around their mean. It describes variability among observed values, rather than the precision of the estimated mean itself. Precision also depends on how many observations contribute and on the analysis method. Although the registry names standard deviation as the dispersion measure for the primary endpoint, it does not report an observed standard deviation for either arm. Therefore, variability in pain changes cannot be assessed from the registry record.

How should a difference between arms be assessed?

In general, a comparison can be expressed as an estimated difference between groups, accompanied by a measure of uncertainty such as a confidence interval. A confidence interval indicates how precisely the effect has been estimated under the assumptions of the method. A narrow interval indicates greater precision than a wide interval; the interval does not by itself remove bias from a non-randomized design. No between-arm estimate or interval is reported for this study. No p-value or statistical test result is reported either.

Because allocation is non-randomized, an unadjusted comparison could reflect differences between groups that existed before the intervention, as well as any association with the intervention. In general, random allocation helps balance measured and unmeasured characteristics on average; non-randomized allocation does not provide that protection. Statistical adjustment may address measured characteristics when appropriate data and a specified method are available, but it cannot guarantee removal of all confounding. The registry does not report an adjustment strategy or the baseline information required to evaluate one.

What does the sample-size illustration mean?

The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such illustrations are hypothetical planning quantities, not observed trial results and not evidence of achieved power. The record does not describe them as the study's original design justification. Numerical illustration values are not available in the registry record described for this analysis, and no observed effect is reported for evaluating them.

In general, a planning calculation estimates the sample size needed under stated assumptions. It does not show that the study had a particular probability of detecting an effect after the data have been collected. A calculation based on an observed effect also depends on that effect estimate, which may be unstable. No sample-size justification for the original trial, target enrollment rationale, or prospective power calculation is reported in the registry record.

Why do repeated observations require care?

The pain measure is collected around physical therapy sessions and then averaged across each patient. In general, repeated measurements from the same person are related; treating every session as independent can understate uncertainty. A patient-level summary is one way to reduce each person's repeated observations to a single value, but the registry does not provide enough detail to determine exactly how the analysis handled differing numbers of sessions, discharge times, or incomplete assessments. The reported timeframe ends at hospital discharge, up to 60 days postoperatively, so observation opportunities may differ among participants.

The secondary endpoints also require clear definitions and analysis choices. Total opioid administration is an amount accumulated during the post-operative period, while physical therapy sessions before clearance is a count. In general, continuous or count outcomes may have distributions that depart from the assumptions of a simple normal model; over-dispersion, where variation exceeds what a basic count model expects, can affect uncertainty estimates. This general point does not establish that over-dispersion occurred in this study. The registry does not report the distributions, analytic models, or outcome results for these secondary measures.

The record lists 20 enrolled participants and 0 analyses. It does not report a protocol-level statistical analysis plan, interim analyses, handling of missing outcome data, or analysis populations. Without those details and the estimates themselves, readers cannot reproduce the comparisons or assess whether the methods matched the registered endpoint definitions.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Virtual Reality Intervention", "Control")
n   <- c(10, 10)
m   <- c(-0.72, 0.61)
sp  <- c(1.2, 1.1)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Virtual Reality Intervention  10  -0.720  1.200  -1.578  0.138
CARM  Control  10  0.610  1.100  -0.177  1.397

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and two secondary outcomes. Considering several outcomes can raise a multiplicity question: in general, testing multiple hypotheses can increase the chance of at least one apparently notable finding if each is considered separately. Whether and how to control that issue depends on the study's prespecified analysis strategy. A multiplicity plan, hierarchy of outcomes, or adjustment method is not reported in the registry record. The absence of reported analyses also means there are no outcome-specific test results to interpret in light of multiplicity.

Missing-data handling is likewise not reported. The primary endpoint requires pain assessments before and after physical therapy sessions, and the average is intended to be calculated for each patient. The record does not say how incomplete pairs, missed sessions, discharge, or participants without a calculable average were handled. It does not give the number with available primary-outcome data or explain whether any imputation or other missing-data method was used.

The secondary outcomes may also have different availability or denominators, but those details are not reported. Enrollment of 20 does not establish that all enrolled participants contributed to each outcome. An analysis population, such as all enrolled participants or a defined subset, is not specified. The registry lists 0 analyses, so the record does not describe an intention-to-treat analysis or another population definition.

In general, missingness can affect both the representativeness of the analyzed participants and the precision of estimates. Its implications depend on why data are missing and on the analysis strategy. Since the registry gives neither outcome-level completeness nor the reasons for missing data, the extent and potential impact of missingness cannot be assessed.

12. 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.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for 10 participants at risk in the virtual reality arm and 10 at risk in control. Serious adverse events affected 0 participants in each arm. Deaths are recorded as 0 in each arm. These are the recorded counts; they should be interpreted as descriptive safety reporting, not as a definitive estimate of comparative risk.

For other adverse events, 10 participants are listed at risk in each arm. The registry records 6 affected participants in the virtual reality arm and 0 in control. The record does not list the specific terms for these other events, their severity, timing, duration, or relationship to the intervention. It also does not explain how events were collected or define the reporting period beyond the study's post-operative context.

In general, counts from a small study can be imprecise, and zero recorded events does not establish that an event cannot occur. Comparisons of these counts also require caution because allocation was non-randomized and the record does not report an adjusted safety analysis. The adverse-event figures should therefore be read as the registry's reported counts, not as proof for or against a safety difference.

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

The registry establishes that a completed, non-randomized study evaluated post-operative virtual reality in pediatric patients who underwent corrective surgery for idiopathic scoliosis. It describes a pain endpoint based on changes around physical therapy sessions and lists opioid administration and physical therapy sessions before clearance as secondary outcomes. It also reports adverse-event counts for the two arms.

However, the registry does not report the primary or secondary outcome results, an estimated comparison, or uncertainty measures. It therefore does not show whether pain changes, opioid administration, or physical therapy sessions differed between the arms, nor how large or precise any difference may have been. The adverse-event counts are not a substitute for these outcomes and do not provide a complete account of event types or circumstances.

Even if group outcome differences were reported, the non-randomized allocation would limit causal interpretation. In general, the groups may differ for reasons other than intervention assignment, and an observed association may reflect those differences. The registry does not report how participants were assigned, whether the analysis adjusted for baseline differences, or whether other potential confounders were assessed.

The study's enrollment of 20 is the total recorded enrollment, not necessarily the number contributing to every endpoint. The record does not report outcome-specific denominators, missing-data handling, or an analysis population. As a result, the completeness and representativeness of any unreported outcome analysis cannot be judged.

The most defensible reading is therefore limited: the record describes the study's design and intended measures, but offers insufficient outcome reporting to determine comparative effectiveness or estimate precision. It also does not support a definitive comparative safety conclusion. The findings and limitations cannot be extended beyond what the registry actually records.

14. Why This Trial Matters Statistically

This study raises a useful statistical question about how recovery outcomes are measured around care activities. Its primary endpoint is not a single pain score, but a patient-level average of changes before and after physical therapy sessions. That construction highlights the importance of defining the unit of analysis: individual sessions are repeated observations within a patient, while the stated summary is calculated across sessions for each patient.

The design also illustrates the distinction between an intervention comparison and a causal experiment. The registry identifies two parallel arms, but allocation is non-randomized and masking is absent. These design features make it important to know how assignment occurred, whether baseline differences were examined, and whether adjusted analyses were planned. Those details are not reported. Without them, interpretation of any group difference would require particular caution.

The registry includes multiple kinds of outcomes: a continuous pain summary, an amount of opioid administration, and a count of physical therapy sessions before clearance. In general, different outcome types can require different summaries and models. Their distributions, data completeness, and analytic methods affect how estimates and uncertainty should be read. The record does not provide those results or methods.

Finally, transparent outcome reporting is essential to statistical interpretation. Enrollment and endpoint definitions describe what a study set out to examine; they do not reveal what the observations showed. Here, the registry records 0 analyses and does not report effect estimates or confidence intervals. The gap between a clearly described research question and the absence of posted outcome estimates is itself important: readers cannot assess magnitude, precision, or compatibility with different effects from the available record.

15. 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 most important limitation for interpretation is that the registry record does not report outcome estimates or statistical analyses. No results are reported for the primary pain measure or either secondary outcome. Without means, standard deviations, group comparisons, or uncertainty measures, the magnitude and precision of outcomes cannot be evaluated.

The non-randomized allocation is a design limitation for comparing arms. The registry does not report how participants entered each arm, whether relevant characteristics were balanced, or whether statistical adjustment was used. Masking is recorded as none, and the record does not describe safeguards against differences in assessment or care between arms.

Although enrollment is recorded as 20, final arm-specific counts and outcome-specific denominators are not reported. Missing-data handling, reasons for incomplete measurements, and the analysis population are also not reported. These gaps are particularly relevant to a pain summary based on repeated assessments around physical therapy sessions and to outcomes observed during a post-operative period that ends at discharge.

The registry does not report the detailed intervention protocol, a statistical analysis plan, a rationale for the original sample size, or a multiplicity strategy. It also does not provide event terms for the other adverse events recorded in the virtual reality arm. Consequently, neither outcome analyses nor the safety reporting can be examined in detail from this record.

These limitations describe gaps in the registry record; they do not establish that procedures or analyses were absent from the conduct of the study. They do mean that those procedures and results cannot be assessed from the posted information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population — NCT06101264.
• Registry record last updated 2025-09-22; status last verified 2025-09.
• Results first posted 2025-09-22.
• 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.

19. Record Summary

NCT06101264 is a completed, parallel, non-randomized study sponsored by Connecticut Children's Medical Center. The registry records enrollment of 20, no masking, and a comparison between post-operative virtual reality and control among pediatric patients undergoing corrective surgery for idiopathic scoliosis.

The primary outcome is average change in subjective pain before and after physical therapy sessions, measured on a 10 point Likert scale. Secondary outcomes are total opioid administration during the post-operative period and the number of physical therapy sessions before clearance. The registry records serious adverse events and deaths as 0 in both arms, and other adverse events affecting 6 participants in the virtual reality arm and 0 in control.

Outcome estimates, statistical analyses, missing-data methods, and an analysis population are not reported in the registry record. The non-randomized design and absent outcome results limit comparative interpretation.