Virtual Reality Pain Neuroscience Education for Middle School Students: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Virtual Reality Pain Neuroscience Education for Middle School Students (NCT04470375), a na na study. The primary outcome is Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later.

2. Clinical Question

The study was designed to investigate use of a virtual reality platform for delivering pain neuroscience education to middle school students. The stated educational aim concerned pain knowledge and beliefs. The primary measure was a pain beliefs questionnaire comprising five questions about pain and pain control. Each question used an 11 point Likert scale, with responses from 0, strongly disagree, to 10, strongly agree.

The questions do not all point in the same direction. Higher scores were described as more positive beliefs for questions about pain being normal, control over pain, and the brain's role in pain. Higher scores were described as worse beliefs for questions about pain indicating tissue problems and pain always requiring activity to stop. This makes the handling and interpretation of item scores important. The registry record does not report how item responses were combined or how an overall change score was calculated.

3. Trial Design

The registry record describes a completed, single-group cohort study of virtual reality pain neuroscience education for middle school students. The study lists an enrollment of 20 and one intervention arm, called VR pain education. Students in that arm received pain education through virtual reality. The intervention is classified as behavioral.

The primary assessment was a before-and-after measurement: pain beliefs were assessed at baseline and immediately after the intervention, described as approximately 45 minutes later. This design can describe change over time within the participating group. Because no separate control group is listed, it cannot by itself distinguish change associated with the educational session from change that could occur for other reasons, such as familiarity with the questionnaire or events during the study period.

The record lists allocation as not applicable and masking as none. It does not describe random assignment, and the study is not a randomized comparison. The registry record does not report additional details about recruitment, eligibility criteria, study setting, participant demographics, intervention delivery procedures, or adherence. The study dates listed are 2020-08-04 for the start and 2020-08-05 for primary completion; its status is completed.

Three outcome measures and three analyses are listed, but the registry information available for this account does not give their results or explain the analysis methods used for each. Details of a prespecified statistical analysis plan, including any covariate adjustment or approach to repeated measurements, are not reported in the registry record. The listed sample-size planning assumptions describe an illustration for a two-arm comparison, whereas the study itself is single-group; such an illustration should not be read as the study's actual design or as observed power.

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: No exclusion prior to assignment

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.

Population: Middle school students

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later, measured over Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR.

The primary endpoint is change from baseline in the Pain Beliefs Questionnaire score after the virtual reality intervention, assessed immediately afterward. The registry describes the assessment as occurring approximately 45 minutes after viewing Pain VR. A change measure is intended to capture how responses differ between the pre-intervention and post-intervention assessments, rather than describing only the score at a single time.

The questionnaire asks about five beliefs: whether pain is normal and necessary for survival, whether pain means tissue damage, whether pain always requires stopping an activity, whether pain can be controlled, and whether the brain rather than the tissues decides whether pain is felt. Responses use an 11 point Likert scale from 0, strongly disagree, to 10, strongly agree. The registry describes the outcome as a mean with standard deviation.

The endpoint is relevant to the study's stated focus on pain knowledge and beliefs. Its interpretation requires care because higher responses indicate more positive beliefs on some questions and worse beliefs on others. The registry record does not report whether responses were recoded, how item scores were combined, whether the reported score is an average or another summary, or how missing item responses were handled. It also does not provide baseline or post-intervention values, a change estimate, or a measure of uncertainty. Therefore, the endpoint's observed direction and magnitude cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

A before-and-after study measures outcomes in the same study group at different times. The primary outcome in this study is described as change from baseline to immediately after virtual reality education. This structure makes the participants' baseline scores a reference for interpreting their later scores. It does not create a concurrent control group. General statistical interpretation must therefore distinguish a within-group change from a treatment effect established by comparison with an alternative.

What does a mean describe?

The registry identifies the primary outcome as a mean with standard deviation. In general, a mean describes the average value in a set of measurements. A standard deviation describes how spread out individual measurements are around that average. These quantities answer different questions: the mean describes the center of the observed scores, while the standard deviation describes variability among them. Neither is reported numerically for the primary outcome in the registry record.

The questionnaire uses five questions, each with responses on an 11 point Likert scale from 0 to 10. Such response scales order levels of agreement. How the answers are summarized matters: the registry record does not state whether the analysis used individual question scores, a combined score, or another scoring rule. It also does not report how the opposing directions of the positively and negatively worded questions were handled. Those choices affect what a higher or lower summary score would mean.

What can a confidence interval tell a reader?

In general, a confidence interval expresses uncertainty around an estimated quantity. It is useful for assessing both the range of effect sizes compatible with the data and the estimate's precision. It is not a guarantee that the true value lies within a particular interval, and it does not replace consideration of the design or measurement. The registry record does not report a confidence interval for the primary outcome.

A statistical test can assess compatibility between data and a specified null hypothesis under its assumptions. A p-value is not a measure of the size or importance of a change, nor does it resolve the limitations of a single-group design. No primary-outcome test statistic or p-value is reported in the registry record. The record also does not provide enough information to identify a particular testing procedure.

Why does the single-group structure matter?

In a randomized comparison, groups can provide a basis for estimating differences between assigned interventions, subject to the study's methods and conduct. This study is listed as single-group, with allocation not applicable and no separate comparator. A within-person before-and-after contrast can account for each participant's baseline measurement in describing change, but the contrast does not show what would have happened over the same period without the intervention. General alternative explanations include measurement familiarity, shifts in responses after learning the material, or other changes over time.

Repeated measurements on the same person are related rather than independent. General analysis methods should account for that pairing when estimating uncertainty for change. The registry record does not describe the method used to account for repeated observations, or whether analyses used individual paired data or summary measures.

How should the planning illustration be read?

The sample-size assumptions describe a planning illustration based on a stated fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For non-time-to-event outcomes, the stated convention is participants per arm. These are hypothetical planning assumptions, not a description of this single-group study's allocation. A planning calculation estimates the sample size needed under its assumptions; it is not observed power and does not establish that the study was adequately powered. The registry record does not report the protocol's sample-size justification or the values needed to assess such a justification.

In general, over-dispersion occurs when observed variability is greater than a model assumes. If not accounted for, it can make uncertainty estimates too small and statistical evidence appear stronger than warranted. This primary measure is described as continuous, and the registry record does not report a model or an over-dispersion assessment. No claim about over-dispersion or its handling can therefore be made for this analysis.

Finally, statistical results depend on both the analysis method and how outcome data were collected and processed. The registry record does not report a detailed statistical analysis plan, score-construction rules, handling of missing observations, or analysis population. Those omissions limit independent assessment of the endpoint analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and three analyses. It identifies change in Pain Beliefs Questionnaire score as the primary outcome, but the record does not report how the other outcomes were classified or analyzed. It also does not report whether the analyses were planned as confirmatory or exploratory.

When multiple outcomes or statistical tests are considered, the chance of at least one result appearing notable by chance can increase. General approaches include prespecifying a primary analysis, adjusting for multiple testing, or clearly labeling analyses as exploratory. The registry record does not report a multiplicity adjustment, a testing hierarchy, or another approach for addressing multiple analyses. No conclusion about whether multiplicity was considered can be drawn from the listed counts alone.

The registry record does not report whether outcome data were missing, how missingness was defined, or how any missing observations were handled. It does not describe imputation, complete-case analysis, or sensitivity analyses. The analysis population is also not reported: the record does not say which enrolled participants, or which measurements, were included in each outcome analysis.

These omissions matter because missing data and analysis-population choices can affect the estimate and its uncertainty. Without those details and the outcome results, it is not possible to assess whether the primary analysis followed a prespecified plan or how robust any result might be to alternative handling of incomplete data.

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 lists one group, Middle School VR Students. For serious adverse events, 20 participants are listed as at risk and 0 as affected; for other adverse events, 20 are listed as at risk and 0 as affected. The death count is 0. No serious adverse-event terms are listed.

These figures describe what the registry reports for the listed group. A zero affected count means that the registry records no affected participants in those categories; it does not establish that no event of any kind could have occurred or been detected. The record does not provide adverse-event definitions, collection procedures, observation windows, or detail about how events were assessed.

The safety figures are not a comparison between intervention and control groups, because the study is single-group. They should be read as descriptive registry counts, not as an estimate of relative risk. The registry record also does not report information that would support a broader assessment of safety beyond the listed serious adverse events, other adverse events, and deaths.

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

The study addresses a specific educational question: whether pain beliefs can be assessed before and immediately after a virtual reality pain neuroscience education session for middle school students. Its primary outcome is a questionnaire-based measure of beliefs, with the post-intervention assessment described as occurring approximately 45 minutes after the session. This makes the research question about short-term change in responses, not about longer-term knowledge retention, behavior, or clinical outcomes.

The registry record does not report the primary outcome values or statistical results. It therefore does not establish whether scores changed, the size or direction of any change, or how precisely a change was estimated. The record also does not provide a scoring method that would clarify the interpretation of an overall score across questions with differing directions.

Even if a before-and-after difference were available, the single-group design would describe change in the participating group rather than provide a controlled estimate of the intervention's effect. Without a separate comparator, the analysis could not rule out alternative explanations for a change over time. The design also does not directly compare virtual reality delivery with in-person education or video-recorded sessions; the brief summary mentions earlier work with those formats but does not present them as study arms in this trial.

The record's completed status indicates that the study is listed as completed, not that its findings are fully reported. The enrollment figure and safety counts provide descriptive information, but they do not substitute for the primary outcome results or an analysis of uncertainty. The registry record does not report longer-term follow-up or a threshold for interpreting a meaningful questionnaire change.

In short, the record specifies an intervention, a study group, and a short-term questionnaire endpoint. It does not provide the results needed to judge the observed change, its precision, or its broader implications. No conclusion about comparative effectiveness can be drawn from the registry information reported.

13. Why This Trial Matters Statistically

This study is statistically notable because it pairs an educational intervention with a before-and-after measure of beliefs in a defined student group. That setup makes clear why design and interpretation must be considered together: a change score can describe what happened across assessments, but a single-group study does not provide a concurrent counterfactual for what would have happened without the session.

The questionnaire also illustrates how measurement details influence statistical interpretation. The five questions do not share a single direction for what higher scores mean. Without a stated scoring or recoding procedure, an overall score may be difficult to interpret even if a mean change were reported. Clear reporting of item handling, score construction, and uncertainty would help readers understand what an estimate represents.

The registry lists multiple outcomes and analyses, making prespecification and multiplicity relevant reporting considerations. It does not describe how multiple analyses were handled or identify the methods used for each. Reporting the analysis plan, results, and missing-data approach would make it easier to assess the strength and limits of any findings.

Finally, planning calculations should be separated from results. A planning illustration under two-arm assumptions does not describe the actual single-group design, and it is not observed power. This distinction is useful whenever hypothetical planning scenarios appear alongside results from a study with a different structure.

These considerations matter beyond this study: transparent reporting of design, scoring, analysis, and uncertainty is necessary for readers to evaluate what an educational study can and cannot establish.

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 registry record does not report the primary outcome values, change estimate, confidence interval, or statistical test result. The size, direction, and precision of any change therefore cannot be evaluated from the record.

The single-group design has no separate comparator, so a before-and-after difference would not isolate the intervention from other explanations for change over time. The registry lists no random allocation and describes no masking. The record does not report whether participants' responses may have been influenced by familiarity with the questionnaire or by learning how the questions relate to the educational material.

The primary measure includes positively and negatively worded items. Although the record describes the direction of higher scores for each type, it does not explain how item responses were recoded or combined into the reported score. It also does not report the questionnaire's administration details beyond baseline and immediately post-intervention timing, or provide a threshold for a meaningful change.

Participant eligibility criteria, demographic characteristics, setting, recruitment procedures, adherence, and intervention fidelity are not reported in the registry record. These gaps limit assessment of how the study group was assembled and how broadly findings, if reported, might apply.

The record lists three outcomes and three analyses but does not describe multiplicity handling, missing-data methods, or analysis populations. It also does not report the statistical analysis plan or protocol sample-size justification. The listed planning assumptions concern a hypothetical two-arm comparison, unlike the single-group study design, and should not be treated as evidence about the study's actual power.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Virtual Reality Pain Neuroscience Education for Middle School Students — NCT04470375.
• Registry record last updated 2021-02-05; status last verified 2021-01.
• Results first posted 2020-12-22.
• 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.

18. Record Summary

NCT04470375 is a completed, single-group cohort study titled “Virtual Reality Pain Neuroscience Education for Middle School Students.” The sponsor is the University of South Dakota. The registry lists an enrollment of 20, a start date of 2020-08-04, and a primary completion date of 2020-08-05.

The intervention was virtual reality pain neuroscience education, described as a 45 minute session for middle school students. The primary outcome was change from baseline in Pain Beliefs Questionnaire score immediately after the intervention, approximately 45 minutes later. The questionnaire covered five beliefs and used responses from 0 to 10.

The registry record does not report the primary outcome results, analysis methods in detail, or missing-data procedures. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths for the group.