This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Virtual Reality in Pediatric Dentistry (NCT05585905), a randomized na study. The primary outcome is Beats Per Minute Change With VR.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05585905 |
| Phase | NA |
| Condition | Behavior, Child, Anxiety, Dental |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | 4 |
| Lead sponsor | University of Southern California |
| Results posted | Yes |
2. Clinical Question
Population
Children ages 6-18 who were healthy and required two or more dental sealants, with at least one sealant on each side, were eligible according to the study description. The registry lists enrollment of 20. The question concerns heart-rate change during sealant placement in this pediatric dental setting; the results do not directly describe other ages, procedures, or patient groups.
Intervention
The intervention was virtual reality (VR) distraction during dental sealant placement. The registry describes an immersive headset system, RelievRx by AppliedVR. Children were assigned to receive VR on one side, as part of a sequence in which the other side received basic behavior guidance techniques.
Comparator
The comparator was basic behavior guidance (BBG), described in the registry as standard of care and common in pediatric dentistry. Each child served as their own control in a split-mouth crossover design, with the order of VR and BBG and the side treated varying across the listed groups.
Primary question
Does heart rate change from baseline during sealant placement with VR differ in relation to placement using BBG? The registry describes exploring the association between VR use and anxiety measured by heart-rate change. The posted primary outcome reports mean changes and full ranges within sequence groups, rather than an estimated VR-versus-BBG treatment contrast with uncertainty. Those summaries alone do not establish whether the average change differs between treatment conditions.
3. Trial Design
This was a randomized, open-label crossover study, classified in the registry as a pilot. Its stated purpose was to investigate virtual reality during dental procedures in children, including anxiety, behavior, and pain. The described procedure focused on dental sealant placement. Eligible children were ages 6-18, healthy, and required at least two sealants, including one on each side. The registry records enrollment of 20 and lists the study as completed.
The split-mouth crossover design made each child their own control: VR was used on one side and basic behavior guidance on the other. Random assignment determined the order and side combinations described in four sequence groups. Two groups began with VR and then received BBG; the other two began with BBG and then received VR. The arm descriptions also specify which side was treated first. This arrangement is relevant to interpretation because a comparison may depend not only on treatment but also on visit or period, sequence, and side.
The study was not masked. The registry’s study description says its proposed model would include treatment, visit, a treatment-by-visit interaction, and treatment sequence. However, the same description says that no statistical analysis would be conducted beyond means and ranges, and the record lists no posted analyses. It therefore does not establish that the proposed model was fitted or that an adjusted treatment effect was estimated.
The registry gives a start date of 2023-03-17 and a primary completion date of 2024-06-30. It does not report the crossover interval, any washout procedure, or detailed rules for handling differences between the two treatment periods. Those details would help assess possible period or carryover effects, but should not be inferred from the sequence descriptions.
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
| Stage | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant |
|---|---|---|---|---|
| STARTED | 4 | 4 | 8 | 4 |
| COMPLETED | 4 | 4 | 7 | 4 |
| NOT COMPLETED | 0 | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant |
|---|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The numbers listed are the number of participants in each group which were randomly selected. The study was a pilot study.
| Characteristic | Unit | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 4 | 4 | 8 | 4 | 20 | |
| Age, Categorical: <=18 years | Participants | 4 | 4 | 8 | 4 | 20 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 3 | 2 | 4 | 4 | 13 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 4 | 0 | 7 |
| Race and Ethnicity Not Collected | Participants | — | — | — | — | 0 |
| Heart Rate Baseline | beats per minute | 87.7 (64 to 106) | 75.25 (63 to 92) | 76.6 (61 to 90) | 90.75 (80 to 108) | 82.575 (61 to 108) |
6. Primary Endpoint
The registry lists the primary outcome as Beats Per Minute Change With VR, measured over Time from is from baseline until sealant placement with VR.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | Beats per minute |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in heart rate, measured in beats per minute, from baseline until sealant placement with VR. The registry describes heart rate at baseline and during sealant placement as a measure of behavior and anxiety. The posted summaries give a mean and full range for each listed treatment-sequence group. They do not provide a standard deviation, confidence interval, or a direct estimate of the difference between VR and BBG.
Heart rate is a physiological measure that can be observed during a procedure. In general, measuring change from baseline can describe how a measurement shifts during an event relative to its starting value. A negative change in the posted summaries means the recorded heart rate during placement was lower than the baseline value on average for that sequence group. It is not, on its own, a direct measure of a child’s reported anxiety, behavior, or pain, and it cannot identify why heart rate changed.
The four sequence-group means are -2.0, -6.25, -8.8, and -6.25 beats per minute. Their full ranges are -9 to 2, -9 to -4, -18 to 4, and -12 to -3, respectively. Because these are summaries by sequence, they do not isolate the treatment-specific change while accounting for order, visit, or side. The registry does not report a treatment contrast or uncertainty interval for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome consists of mean heart-rate changes and full ranges in four sequence groups. In the groups that received VR first, the reported means were -2.0 and -6.25 beats per minute. In the groups that received BBG first, the reported means were -8.8 and -6.25 beats per minute. These values describe change from baseline in each sequence group; they are not separate estimates of the VR effect and BBG effect. Each group includes both treatments in a different order, so its summary cannot be read as a treatment-only result.
The ranges also vary by sequence group. They extend from -9 to 2, -9 to -4, -18 to 4, and -12 to -3 beats per minute in the order listed. A full range reports the observed extremes, not the precision of a mean estimate. It does not show how values were distributed between those extremes. The registry does not post standard deviations or confidence intervals for these means, nor a formal comparison of treatments. Consequently, the summaries do not quantify the uncertainty around a VR-versus-BBG difference.
In a crossover study, interpretation ordinarily considers treatment, period or visit, treatment order, and possible carryover. A child’s heart rate may change between periods for reasons other than the treatment being used. The registry says the planned model would include treatment, visit, their interaction, and sequence, but it also describes analysis as limited to means and ranges. The record lists zero posted analyses. No fitted model estimates or adjusted treatment comparisons are reported, so the treatment-by-visit or sequence effects cannot be assessed from the posted results.
The listed sequence-group counts are 4, 4, 7, and 4. These are descriptive group counts, not treatment-specific sample sizes for a parallel-group comparison. The registry records enrollment of 20, but the record does not explain how enrollment relates to the numbers appearing in the outcome summaries. No explanation of missing outcome data or exclusions is reported, so the difference between those record elements should not be resolved by assumption.
Overall, the posted data describe heart-rate changes observed in the four treatment sequences. They do not establish whether VR differs from BBG on the primary outcome, how large a treatment effect might be, or how precisely it has been estimated. This is a pilot study with descriptive outcome summaries, and the available record supports a descriptive rather than inferential reading.
9. Statistical Methods Explained
What does a crossover design compare?
In a crossover design, a participant receives more than one condition in sequence. Here, children received VR on one side and BBG on the other, with randomized order and side combinations. Having each child serve as their own control can account for stable characteristics of that child when estimating a treatment contrast. It does not automatically remove variation associated with treatment period, order, side, or changes during the procedure. The registry’s description recognizes some of these considerations by naming treatment, visit, their interaction, and sequence as terms in a proposed model.
For a treatment effect to be distinguished from a sequence pattern, the analysis needs to use the observations from both periods and account for the design. The posted means instead summarize the outcome by sequence group. Because each group’s description includes both VR and BBG, the group mean is not a mean under VR alone or BBG alone. It cannot be used as a direct treatment contrast without the period-level outcome information and an appropriate analysis.
What does a mean and full range communicate?
A mean gives a central summary of the observed changes in a group. The full range gives the smallest and largest observed values in that group. In general, the range is sensitive to the observed extremes and does not describe how densely values cluster near the mean. Neither a mean nor a range alone gives a standard error or confidence interval. A confidence interval, in general, expresses the uncertainty around an estimate under a specified statistical model; no confidence intervals for the primary outcome are reported in the registry.
The listed means are -2.0, -6.25, -8.8, and -6.25 beats per minute. The corresponding ranges are -9 to 2, -9 to -4, -18 to 4, and -12 to -3. These summaries retain the direction and observed spread of the outcome in each sequence group. They do not show whether a difference between treatment conditions is compatible with no effect or with a range of possible effects, because no treatment contrast and its uncertainty are reported.
Why do period and sequence matter?
In general, crossover analyses distinguish treatment effects from period effects, which are differences associated with when a treatment is received. Sequence effects can also matter if receiving one condition first changes the response in a later period. A treatment-by-period interaction allows the treatment contrast to vary by period. These are statistical concepts, not findings established by the posted summaries. The registry says the model would include treatment, visit, treatment by visit, and sequence; it does not report fitted coefficients or results for those terms.
The record does not report the interval between treatment periods or a washout procedure. It also does not report whether any carryover assessment was conducted. In general, carryover refers to an effect of an earlier condition persisting into a later period. Without relevant design details and period-specific results, its presence or absence cannot be determined from the sequence-group means.
How should the pilot results be read?
The registry identifies this as a pilot study and describes the analysis as limited to means and ranges. In general, descriptive summaries are useful for presenting the observed data, but they are not substitutes for an estimated treatment effect with uncertainty. The record lists no posted analyses. It therefore does not provide a model-based treatment estimate, a test statistic, or a p-value for the primary comparison. The summaries should not be treated as proof that one condition produces a larger or smaller heart-rate change.
The sample-size assumptions in the registry describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such planning calculations, in general, address the sample size that might be needed under stated assumptions; they do not measure the probability that this completed study detected an effect. No numerical planning estimates are reported in the record. They should not be interpreted as observed power or as the study’s original design justification.
What role do clinical measures play?
Heart rate is an objective physiological measurement, but the registry uses it as a measure related to anxiety and behavior. In general, an objective measurement can reduce reliance on subjective rating alone, yet the measure remains a proxy for the experience of interest. A heart-rate change does not directly indicate a child’s perceived anxiety or pain. The registry’s stated broader aims include behavior and pain, but the posted primary outcome is heart-rate change during sealant placement with VR. No additional treatment-specific conclusions about those other experiences can be drawn from this endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and 0 posted secondary outcomes. It does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan for controlling the chance of false-positive findings across multiple analyses. Since no treatment-comparison analyses are posted, there are no reported hypothesis tests to interpret in light of such an adjustment. The record does not say whether any outcomes or analyses were changed during the study.
The registry indicates that values were missing or not estimable for a two-arm comparison for another endpoint. That means the record does not support a two-arm comparison for that outcome; it does not establish why the values were unavailable or whether data were collected. The primary outcome is reported as sequence-group summaries, but no participant-level missingness information, reasons for missing data, or imputation method is reported in the registry record.
The record does not describe an analysis population, such as which participants or treatment periods were included in the outcome summaries, or how protocol deviations were handled. It also does not report whether all randomized participants completed both periods. In a crossover study, missingness in one period can affect which paired comparisons are available. Without the analysis-population definitions and missing-data details, the representativeness of the posted summaries cannot be assessed fully.
These gaps limit interpretation but do not demonstrate that data were missing or that any particular analysis method was used. The record reports descriptive means and ranges and lists no posted analyses. No additional assumptions about exclusions, imputation, or multiplicity handling should be made.
11. What the Result Does, and Does Not, Mean
The posted results show negative mean changes in heart rate across the four sequence groups. The group means range from -8.8 to -2.0 beats per minute, and the full ranges include both negative and positive values in some groups. These are descriptions of the observed group summaries. They do not estimate a VR-versus-BBG difference because each sequence group includes both treatments and the summaries are not separated by treatment period.
The figures do not show how precisely a treatment effect has been estimated. No confidence interval, standard error, or formal test of the primary comparison is reported. A range describes observed values, not uncertainty around a treatment effect. The record therefore does not establish whether a treatment contrast is distinguishable from chance variation, nor does it identify a clinically meaningful threshold for heart-rate change.
Heart rate is used as a measure related to anxiety and behavior, but it is not the same as a child’s reported anxiety, pain, or behavior. A change in heart rate can be consistent with many possible influences, and these summaries do not establish a cause. The registry’s broader aims should not be mistaken for separate posted results on pain or behavior.
The record also does not support conclusions about safety beyond its adverse-event entries. No serious adverse events, other adverse events, or deaths are reported in the listed sequence groups. These entries are the record’s reported counts; they do not establish that an event was impossible or that the study can rule out uncommon harms.
In short, the data offer descriptive pilot-study information about heart-rate change by treatment sequence. They do not demonstrate that VR is better, worse, or equivalent to BBG, and they do not support medical recommendations. A direct, appropriately analyzed treatment comparison with uncertainty and transparent missing-data information would be needed to make a more specific statistical interpretation.
12. Why This Trial Matters Statistically
This study raises a useful statistical question about how to evaluate a distraction technique when each child receives both conditions. A crossover design can make within-child comparison possible, which may be valuable when stable differences between children affect physiological measurements. At the same time, the design requires attention to treatment order, period, side, and possible carryover. The sequence-specific summaries make those design features visible, but they are not themselves a treatment-effect analysis.
The record also illustrates the distinction between an endpoint and the concept it is intended to represent. Heart rate is measurable during sealant placement and is described as an indicator related to anxiety and behavior. It does not directly quantify a child’s subjective experience. Statistical interpretation must remain aligned with the measure actually reported, rather than extending a result to broader outcomes that are not separately summarized.
Finally, descriptive pilot results and inferential evidence serve different roles. Means and ranges can describe observed changes and variability. They cannot replace a treatment contrast with an uncertainty estimate, particularly in a crossover study where period and sequence can matter. The registry names a possible model structure but reports only descriptive analysis and no posted model results. This distinction is important for readers assessing what the data can support and what remains unresolved.
13. 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 primary limitation for interpretation is that the registry reports sequence-group means and full ranges rather than treatment-specific estimates or a direct VR-versus-BBG contrast. No confidence intervals, standard errors, test statistics, or p-values for the primary comparison are reported. Consequently, the magnitude and precision of any treatment effect cannot be assessed from the posted outcome summaries.
The study is identified as a pilot and has enrollment of 20. The four listed sequence-group counts are 4, 4, 7, and 4, but the record does not explain how these counts relate to enrollment or describe the analysis population. It does not report participant flow, completion by period, exclusions, or missing-data handling. These omissions limit assessment of how complete and representative the outcome summaries are.
Several design details that could inform a crossover interpretation are not reported in the registry record, including the interval between periods, washout procedures, and any evaluation of carryover. Although the study description names treatment, visit, treatment-by-visit interaction, and sequence as proposed model terms, no fitted analysis is reported. The effect of side or other period-specific factors therefore cannot be separated from the sequence summaries.
The endpoint is heart-rate change, a physiological measure used as an indicator related to anxiety and behavior. It does not directly measure subjective anxiety or pain, and the posted primary outcome does not provide separate treatment comparisons for those experiences. The record also does not state a clinically meaningful threshold for interpreting a change in beats per minute. These limitations constrain both statistical and clinical interpretation without implying that the study’s observations are invalid.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Virtual Reality in Pediatric Dentistry — NCT05585905.
- Registry record last updated 2026-05-18; status last verified 2026-04.
- Results first posted 2026-05-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NCT05585905, titled “Virtual Reality in Pediatric Dentistry,” is a randomized, unmasked crossover pilot study sponsored by the University of Southern California. The registry lists the study as completed, with a start date of 2023-03-17 and a primary completion date of 2024-06-30. Enrollment is listed as 20.
The study compared virtual reality with basic behavior guidance during pediatric dental sealant placement, using a split-mouth design in which children served as their own controls. The primary outcome was mean change in heart rate from baseline during sealant placement with VR, reported in beats per minute with full ranges by treatment sequence. The registry describes analysis as limited to means and ranges and lists no posted analyses. It does not report a direct treatment contrast or uncertainty interval for the primary outcome.
The record lists no serious adverse events, other adverse events, or deaths in the sequence groups. It does not report detailed missing-data methods, the analysis population, or several crossover implementation details. The posted results are descriptive and do not establish a comparative treatment effect.