Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome (NCT03762213), a randomized na study. The primary outcome is The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS).

2. Clinical Question

3. Trial Design

This was a pilot randomized controlled trial with a parallel-group design and no masking. The registry lists an enrollment of 30. The posted primary-outcome results include 16 participants in the Oculus GO group and 14 in the iPad group. These are the group counts attached to the reported outcome values; further details about the analysis population and participant flow are not reported in the registry record.

The two groups received Happy Place content through different devices. The Oculus GO was a stand-alone virtual reality head-mounted display that blocked the surrounding environment. The comparator used an iPad screen and earphones to present a flat version of the application. The registry says the control group watched the same content for the same duration. The virtual reality and iPad experiences therefore differed in presentation, including the immersive headset format, rather than in the named application content.

The stated purpose was to assess feasibility and acceptability and to generate outcome domains for a future randomized trial testing immersive virtual reality for pain intensity in pediatric AMPS. The registry classifies the trial phase as not applicable and its status as completed. The listed start date is 2018-12-20 and the primary completion date is 2019-08-29. Details such as the randomization sequence method, allocation concealment, session procedures beyond the stated content and duration, and recruitment setting are not reported in the registry record. With no masking, participants and those delivering the device experience could know which format was used; whether outcome assessors or analysts were masked is not reported.

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 The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS), measured over VAS will be administered at 5 minutes before the relaxation session, 5 minutes after the session and then at day 2 after the session in both groups..

The primary endpoint was mean change in pain intensity reported on the visual analog scale. The registry describes the VAS as a self-reported measure in which a participant marks a point on a line representing current pain. The line is described as usually running from 0 mm, meaning no pain, to 100 mm, meaning pain as bad as it could possibly be. The resulting score is determined by the position of the mark.

The primary change was defined over the immediate period from 5 minutes before the relaxation session to 5 minutes after it. The registry also specifies an assessment at day 2 after the session in both groups, but the stated primary endpoint is the mean change across the pre-session and immediate post-session assessments. The posted outcome values are expressed in units on a scale.

A self-reported pain measure captures the participant’s own perception, which is the experience the outcome is intended to represent. Repeated assessments can describe change over the specified period. General statistical interpretation: a group mean summarizes the average change in that group, but it does not show how much individual participants varied or whether every participant’s score changed in the same direction. Those individual-level details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The posted primary outcome is continuous: it is a numerical pain-intensity score, and the registry reports a mean change for each randomized group. For a continuous outcome, a group mean gives a compact description of the central tendency of participants’ measured changes. It is useful for describing average change, but it does not convey the spread of individual responses. The registry reports confidence intervals rather than a standard deviation or another measure of participant-level variability.

What does the confidence interval describe?

General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity, such as a group mean. Its width depends on factors including the variability of measurements and the amount of information available for the estimate. A narrower interval indicates greater statistical precision for that estimate under the analysis assumptions; it does not guarantee that the estimate is unbiased or clinically important. A confidence interval is not an interval for individual participant outcomes.

For this trial, the registry labels the reported dispersion as a 95% confidence interval. The interval accompanies each arm’s mean change. The method used to calculate the intervals, the handling of repeated measurements, and any assumptions used in their calculation are not reported in the registry record. The interval estimates therefore can be described as posted, but not independently reconstructed from the record.

Why is the between-group contrast important?

Randomization is intended to support a comparison between groups by allocating participants to different study conditions. The treatment question concerns the difference in outcome between those conditions, rather than whether either group’s average score changed on its own. A direct contrast estimates how different the reported mean changes were between the randomized groups and should be accompanied by uncertainty for that contrast. The registry record does not report such an estimate or a corresponding test. It lists zero analyses, and the registry entries indicate that values for a two-arm comparison of this continuous endpoint were missing or not estimable.

Separate within-group confidence intervals are not a substitute for the confidence interval around the difference. A comparison requires accounting for the uncertainty in both groups and the analysis design. It is not valid to judge the between-group result only by comparing the two group means or by visually comparing their separate intervals. No recalculated comparison is available in the registry record; consequently, there is no recalculated result to set against a sponsor analysis.

What can a mean change miss?

General statistical explanation: an average can conceal variation, skewness, or subgroups with different patterns of response. A mean change also depends on how the change score is defined and on which observations are included. The record identifies the pre-session and immediate post-session timing for the primary measure, but does not report a detailed analysis population, participant-level observations, or the approach to incomplete measurements. The observed group means alone cannot describe these features.

Repeated VAS measurement is specified at 5 minutes before the session, 5 minutes after it, and day 2 after it. The primary outcome description identifies change between the pre-session and immediate post-session measures. Statistical methods for combining repeated observations, accounting for within-participant dependence, or analyzing day-2 scores are not reported in the registry record. It is therefore not possible to characterize whether the day-2 assessment was analyzed with a separate change score, a longitudinal model, or another approach.

What is not available about the analysis?

The registry record does not report the statistical analysis plan, a model specification, covariate adjustment, an approach to missing observations, or the method used to calculate the confidence intervals. It also does not report an inferential test or p-value for the primary between-group comparison. These omissions limit assessment of how the reported summaries were generated and whether the planned analysis was followed. They do not change the descriptive meaning of the posted arm-level results, but they prevent a fuller evaluation of inferential uncertainty.

The stated pilot purpose is relevant to interpretation. Pilot studies can be used to assess feasibility and acceptability and to inform later study design; a descriptive estimate from a pilot may be imprecise and can be sensitive to the participants observed. The registry does not report a sample-size justification or a planned minimum detectable effect. The listed enrollment and outcome group counts should not be treated as evidence of a particular level of power. Any sample-size planning illustration elsewhere should be understood as planning information, not as an observed trial result or evidence of observed power.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the pain-intensity change as the primary outcome and names mean change in pain catastrophizing measured on the Pain Catastrophizing Scale - Child as a secondary outcome. It also notes three outcome measures, but the available record does not identify all of them or provide results for all listed measures. A posted secondary result is not included in the available information. The schedule specifies VAS assessments before and immediately after the relaxation session and at day 2, while the primary endpoint is the immediate change.

When a study assesses multiple outcomes or time points, there can be multiple opportunities to observe results that appear notable by chance. General statistical explanation: multiplicity refers to this collection of related statistical tests or estimates, and methods for addressing it may be specified in advance. Whether and how this trial handled multiplicity is not reported in the registry record. The record does not describe a hierarchy of outcomes beyond identifying the primary outcome, or state whether secondary measures or time points were adjusted for multiple comparisons.

Information about missing data is also not reported in the registry record. There is no stated method for handling missing VAS assessments, incomplete questionnaires, or participants who may not have contributed to a particular time point. The record does not describe an intention-to-treat, per-protocol, or other analysis population, and does not provide participant flow or reasons for missing measurements. The group counts attached to the posted primary results do not, on their own, establish how the analysis population was defined or whether all randomized participants contributed to every assessment.

These gaps matter because choices about outcomes, time points, missing observations, and analysis populations can influence estimates and their uncertainty. Without the corresponding methods, readers should interpret the reported values as the registry’s arm-level summaries and avoid treating them as a complete prespecified statistical analysis.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events affecting participants in the Oculus GO group and zero in the iPad group. It also reports zero deaths in each group. For other adverse events, the record lists 9 affected participants among 16 at risk in the Oculus GO group and 5 affected participants among 14 at risk in the iPad group. These are the registry’s counts; they do not establish the nature, severity, timing, or relationship of the other events to the study experience.

A count of zero reported serious events means that none were recorded as affecting participants in that group in the registry results. It does not prove that an event was impossible, nor does it provide a precise estimate of the underlying risk. General statistical explanation: rare events are difficult to characterize in small studies, because a study may observe few or no events even when the underlying event probability is not zero. The record does not include serious-event terms, and further details about adverse-event definitions, collection procedures, or attribution are not reported in the registry record.

The safety figures are descriptive and should not be read as a statistical comparison between devices. The registry does not report an analysis of adverse-event differences. The other-adverse-event counts should also not be equated with serious adverse events; they are presented separately in the record.

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

The posted results describe mean changes in self-reported pain intensity over the immediate interval around a relaxation session. The Oculus GO group’s reported mean change was -14.9 units on a scale, with a 95% confidence interval from -22.9 to -6.9. The iPad group’s reported mean change was -9.6 units on a scale, with a 95% confidence interval from -14.3 to -4.9. These figures describe group averages and their reported uncertainty, not individual trajectories.

The record does not report a direct estimate of the difference between the randomized groups. As a result, the arm-level results do not establish whether the mean change differed between the virtual reality and iPad formats. They also do not support a conclusion about the relative efficacy of the devices. No p-value or comparative confidence interval is reported, and no analyses are listed.

The findings are specific to the stated outcome and timing: VAS change from 5 minutes before to 5 minutes after the relaxation session. Although the record specifies a day-2 assessment, its results are not reported in the available information. The record also names a secondary pain-catastrophizing outcome without a posted result. The findings therefore do not describe longer-term pain, pain-related functioning, acceptability, feasibility outcomes, or all outcomes assessed in the trial.

The trial’s stated role was to assess feasibility and acceptability and generate outcome domains for a future randomized trial. The registry does not report detailed feasibility results or an analysis of acceptability. Nor does it report a sample-size justification, a statistical plan, or enough information to assess missing data and multiplicity. The result should be read as a limited set of descriptive registry summaries from a pilot study, rather than as a complete confirmatory evaluation of the intervention.

More generally, statistical uncertainty and clinical importance are different questions. A confidence interval describes uncertainty in an estimate under the analysis assumptions; it does not determine whether a change matters to patients. The registry record does not report a threshold for a clinically important VAS change, so clinical importance cannot be judged from these summaries alone. No medical advice or treatment recommendation follows from the posted statistics.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between descriptive change and comparative evidence. The record reports a mean change for each randomized group, but the clinical question concerns the difference between formats. Without an estimate and uncertainty for that contrast, the group-level summaries cannot answer the comparative question on their own.

The pilot purpose also shapes how the evidence should be used. The registry describes an aim to assess feasibility and acceptability and generate outcome domains for a future randomized trial. Such work can help identify measures and practical issues for later study, but the posted record does not provide detailed feasibility findings, a statistical analysis plan, or a sample-size justification. The means and confidence intervals should therefore be read in the context of a pilot, not as a definitive test.

The outcome schedule illustrates another important issue: a study can collect repeated measures while identifying only one time contrast as primary. The record identifies an immediate pre-to-post change and also specifies a day-2 VAS assessment. Because day-2 results and methods for handling repeated observations are not reported, the time-specific interpretation remains limited to the posted immediate summaries.

Finally, the registry separates serious adverse events from other adverse events and reports counts for both groups. That distinction is useful for descriptive reading, but the small group counts and lack of comparative safety analysis do not support conclusions about relative safety. Overall, this record shows why outcome definitions, direct comparisons, analysis methods, and complete reporting are all needed to move from observed summaries toward a well-supported statistical conclusion.

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 leaves several trial-specific details unavailable. Eligibility criteria, age range, baseline participant characteristics, recruitment setting, randomization method, and allocation concealment are not reported. Masking is listed as none, but whether outcome assessors or analysts were masked is not reported. These details affect how readers assess the study’s conduct and the relevance of its findings to other pediatric AMPS populations.

The primary results are arm-level means with confidence intervals, but no direct comparison is reported. The record lists no analyses and indicates that values for a two-arm comparison of the continuous endpoint were missing or not estimable. The confidence-interval calculation method, analysis model, and handling of repeated measurements are not reported. The absence of a reported contrast prevents a statistical assessment of the randomized comparison from the registry results.

Important outcome information is also incomplete. The registry specifies a day-2 VAS assessment, but no day-2 result is included in the registry entries. A secondary pain-catastrophizing measure is named, but no result is posted in the available information. Although three outcome measures are noted, not all are identified. The record does not describe missing-data methods, analysis populations, multiplicity handling, or participant flow.

The safety summary provides counts but does not report event descriptions, severity details for non-serious events, timing, or attribution. Finally, the study is explicitly described as a pilot, yet a sample-size justification and detailed feasibility and acceptability results are not reported in the registry record. These limitations constrain interpretation of both the observed outcome changes and the broader study aims.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome — NCT03762213.
• Registry record last updated 2021-01-26; status last verified 2021-01.
• Results first posted 2021-01-26.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry identifies NCT03762213 as a completed pilot randomized controlled trial of audio-visual relaxation technology for pediatric amplified musculoskeletal pain syndrome. The parallel-group comparison used an Oculus GO virtual reality head-mounted display with Happy Place versus an iPad presentation of the same application content. The study was unmasked and enrolled 30 participants.

The primary outcome was mean change in VAS pain intensity from 5 minutes before to 5 minutes after the relaxation session, with an additional day-2 assessment specified. The posted immediate mean changes were -14.9 units on a scale for the Oculus GO group and -9.6 units on a scale for the iPad group, each with a reported 95% confidence interval. The registry does not report a between-group estimate or analysis. It describes the pilot aims as assessing feasibility and acceptability and generating outcome domains for a future trial. Secondary results, detailed statistical methods, and missing-data procedures are not reported in the registry record.