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 Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety (NCT06111742), a randomized na study. The primary outcome is Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06111742 |
| Phase | NA |
| Condition | Anxiety |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 178 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Yale University |
| Results posted | Yes |
2. Clinical Question
Population
Children undergoing elective surgery are the population of interest. The primary measure is specified for child participants only. The registry record does not give further eligibility criteria or describe the enrolled children in detail.
Intervention
The interactive gaming group used the Bedside Entertainment and Relaxation Theater (BERT), an interactive gaming platform, directly before and during induction of anesthesia. The registry describes the intervention as a device.
Comparator
The standard-of-care group was offered standard interventions to improve preoperative anxiety, while the interactive gaming system under investigation was unavailable to that group. The record does not specify which standard-care interventions individual participants received.
Primary question
The trial asks whether offering interactive games around anesthesia induction is associated with a different change in children’s observed perioperative anxiety, measured with the Modified Yale Perioperative Anxiety Score (mYPAS), compared with standard care without the gaming system. The registry describes mean change from baseline for anxiety during induction and upon operating-room entry. Numerical estimates for these primary outcomes are not reported in the registry record, so the direction and precision of any between-group difference cannot be assessed from the record.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group trial sponsored by Yale University. Its recorded enrollment is 178. The study is marked completed, with a start date of 2023-11-14 and a primary completion date of 2024-02-12. The phase is recorded as NA.
Participants in the Interactive Gaming Group used BERT directly before and during induction of anesthesia. Participants in the Standard of Care group were offered standard interventions to improve preoperative anxiety, and the gaming system was unavailable to them. The record does not identify the standard-care interventions in more detail or report how the random allocation sequence was generated or concealed.
The registry labels masking as double, but does not state which roles or participants were masked, how masking was maintained, or whether it was assessed. Those details are therefore not reported in the registry record. The parallel design indicates that the intervention groups are compared as separate groups rather than as a crossover sequence; the record does not describe further design procedures.
The primary outcome is child anxiety measured with mYPAS. Other listed outcomes concern caretaker anxiety, healthcare professional opinions about BERT, and patient compliance with induction. The record lists four outcome measures and four analyses, but numerical primary outcome estimates and details of the statistical analysis plan are not reported in the registry record.
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: One participant randomized to experimental arm did not receive intervention
Overall Study
| Stage | Interactive Gaming Group | Standard of Care | Healthcare Professionals |
|---|---|---|---|
| STARTED | 74 | 74 | 30 |
| Child Participants | 37 | 37 | 0 |
| Caretakers | 37 | 37 | 0 |
| COMPLETED | 71 | 74 | 30 |
| NOT COMPLETED | 3 | 0 | 0 |
Reasons for not completing this period:
| Reason | Interactive Gaming Group | Standard of Care | Healthcare Professionals |
|---|---|---|---|
| Did not receive intervention | 1 | 0 | 0 |
| Withdrawal by Subject | 2 | 0 | 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.
| Characteristic | Unit | Interactive Gaming Group | Standard of Care | Healthcare Professionals | Total |
|---|---|---|---|---|---|
| Participants analysed | 74 | 74 | 30 | 178 | |
| Age, Continuous: Child participants | years | 7.35 (SD 2.04) | 6.43 (SD 1.98) | — | 6.89 (SD 2.05) |
| Age, Continuous: Caregivers | years | 37.8 (SD 6.1) | 37 (SD 7) | — | 37.4 (SD 6.07) |
| Sex: Female, Male: Child Participants – Female | Participants | 18 | 17 | — | 35 |
| Sex: Female, Male: Child Participants – Male | Participants | 19 | 20 | — | 39 |
| Sex: Female, Male: Caregivers – Female | Participants | 29 | 32 | — | 61 |
| Sex: Female, Male: Caregivers – Male | Participants | 8 | 5 | — | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 13 | 13 | — | 26 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 21 | 24 | — | 45 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 0 | — | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | — | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 4 | — | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 7 | 5 | — | 12 |
| Race (NIH/OMB): White | Participants | 26 | 25 | — | 51 |
| Race (NIH/OMB): More than one race | Participants | 2 | 2 | — | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | — | 2 |
| Region of Enrollment: United States | participants | 37 | 37 | — | 74 |
| Healthcare Professional Title: Anesthesiologist | Participants | 0 | 0 | 5 | 5 |
| Healthcare Professional Title: Anesthesiology Resident/Fellow | Participants | 0 | 0 | 8 | 8 |
| Healthcare Professional Title: Circulating Nurse | Participants | 0 | 0 | 6 | 6 |
| Healthcare Professional Title: Certified Registered Nurse Anesthetist (CRNA) | Participants | 0 | 0 | 3 | 3 |
| Healthcare Professional Title: Scrub Technologist | Participants | 0 | 0 | 3 | 3 |
| Healthcare Professional Title: Surgery Resident/Fellow | Participants | 0 | 0 | 5 | 5 |
| Caregiver Relationship to Participant: Parent | Participants | 34 | 37 | — | 71 |
| Caregiver Relationship to Participant: Other | Participants | 3 | 0 | — | 3 |
| Caregiver Surgical History, Previous Surgery: Yes | Participants | 23 | 28 | — | 51 |
| Caregiver Surgical History, Previous Surgery: No | Participants | 14 | 9 | — | 23 |
| Short State Anxiety Inventory Score at baseline | score on a scale | 10.5 (SD 5.3) | 11.4 (SD 3.1) | — | 10.95 (SD 3.3) |
6. Primary Endpoint
The registry lists the primary outcome as Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS), measured over Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is patient anxiety assessed using the Modified Yale Perioperative Anxiety Score (mYPAS). It is an observational measure developed at Yale University and described in the registry as the gold standard for measuring pediatric perioperative anxiety. It is intended for child participants only.
The instrument has 22 items across five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Its score ranges from 23 to 100, with higher scores indicating higher anxiety. These properties explain what the measure represents; they do not show how participants in this trial scored.
The registry describes the primary result as mean change from baseline in anxiety during induction and upon operating-room entry. The recorded timepoints are baseline at operating-room entry, approximately 1 hour after baseline, and at induction of anesthesia, approximately 65 minutes after baseline. Because the registry record does not report numerical estimates for these primary outcomes, it is not possible to describe the observed change, compare groups, or assess its precision.
In general, an observational anxiety scale makes it possible to represent behavior using a defined scoring system. The record does not report assessor training, inter-rater reliability, or the procedures used to ensure consistent scoring in this trial.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial’s central statistical question is whether mean change in child anxiety measured by mYPAS differs between the interactive gaming group and the standard-of-care group at the reported perioperative assessment points. The registry record identifies the measure and describes the timing, but does not report the primary outcome values, a between-group estimate, a confidence interval, or a p-value. There is therefore no numerical basis in the registry record for judging the size, direction, or precision of the primary comparison.
A mean change is a summary of how scores shift from a baseline assessment. To interpret a comparison, readers would generally need the change in each group and an estimate of the difference between groups, together with uncertainty around that estimate. A confidence interval communicates a range of values compatible with the data and analysis assumptions; a narrower interval generally indicates greater precision. Neither group-specific primary changes nor an interval for a between-group comparison is reported in the registry record.
The score’s stated direction is useful when estimates are available: higher mYPAS scores indicate higher anxiety. However, the registry does not report the numerical changes or specify a subtraction convention for the change scores. No direction of effect can be inferred from the endpoint description alone. The registry also identifies more than one assessment context for the primary outcome, and the record does not reduce these to one primary comparison.
The study is marked completed, but completion status is not itself evidence about the outcome. Enrollment is recorded as 178; that number does not establish how many participants contributed to any particular primary analysis. The safety record lists participants at risk by group, but those figures cannot be used to reconstruct the primary endpoint analysis population. Analysis denominators, exclusions, and handling of incomplete mYPAS observations are not reported in the registry record.
The record’s planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not a report of the trial’s design justification or a measure of observed power. The registry record does not report the underlying effect estimate or numerical planning outputs. Any such calculation should be read as a hypothetical planning aid rather than evidence of the trial’s result.
Overall, the record establishes the study question, the intervention contrast, and the intended anxiety measure, but does not provide the primary estimates needed for an effectiveness interpretation. The absence of a reported estimate is not evidence of no difference; it means the primary comparison cannot be evaluated from the registry record.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome summarized as a mean, with standard deviation as the dispersion measure. In general, a mean describes the center of a set of measured scores, while a standard deviation describes how spread out individual scores are around that mean. These summaries can help readers understand both average anxiety scores and variability, but the registry record does not report primary outcome means or standard deviations.
What does a change score represent?
In general, a change score describes the difference between a participant’s measurement at a later assessment and a baseline measurement. A group mean change summarizes those participant-level changes. Comparing average changes between randomized groups can describe whether their score trajectories differ over the measured period. Interpretation depends on the defined order of subtraction and the assessment timepoints. The registry says results are mean change from baseline during induction and upon operating-room entry, but does not report the numerical changes or a subtraction convention.
Change scores can be useful when the scientific question concerns movement from an initial measurement. They also have limitations: a change score reflects both the later measurement and baseline value, and measurement variability at either time can affect the change. General statistical practice may use other approaches to account for baseline measurements, but the analysis method used for this trial is not reported in the registry record. It would be inappropriate to attribute a specific adjustment method to the investigators.
How should the scale be understood?
The mYPAS is an observational instrument with a defined score range from 23 to 100; higher scores suggest higher anxiety. Its 22 items are organized into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. A numerical score compresses observations into a summary, which supports comparison, but does not capture every aspect of a child’s experience. In general, consistent observation and scoring procedures matter when a measure depends on observed behavior. Details about assessor preparation or agreement among assessors are not reported in the registry record.
Although the primary endpoint is continuous, that does not by itself determine the statistical test or model. General choices can depend on the distribution of scores, the planned contrast, baseline handling, and other features of the data. The registry record does not report the model, test, or assumptions used for the primary analyses. No method should be inferred solely from the fact that the endpoint is a mean and standard deviation.
What do uncertainty and significance communicate?
In general, an estimate describes the observed contrast, while a confidence interval describes uncertainty around that estimate under the chosen method. A p-value addresses how compatible the data are with a specified null hypothesis under model assumptions; it does not measure the probability that a treatment works, nor does it convey the size of an effect. These measures are most informative when read alongside the estimate and the study context. The registry record does not report an effect estimate, confidence interval, or p-value for the primary endpoint.
The record includes sample-size planning assumptions: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. In general, planning calculations estimate the sample size needed under stated assumptions. They are not evidence that an effect was observed, and they are not observed power. The registry explicitly distinguishes the planning illustration from the trial’s own design. The underlying observed effect and numerical planning outputs are not reported in the registry record.
Why can over-dispersion matter?
In general, over-dispersion means that observed variability is greater than a statistical model expects. If a model understates variability, its uncertainty estimates can be too small and its intervals or tests can be misleading. This issue is especially relevant to outcomes whose variance is modeled in relation to a mean, such as some counts. The primary endpoint is described as a continuous score summarized by a mean and standard deviation; the registry does not report a model or evidence of over-dispersion. It is therefore not possible to say whether this issue arose or how it was handled.
For the listed safety outcomes, counts are reported rather than an inferential comparison. General comparisons of event counts require attention to the population at risk, observation period, event definitions, and completeness of reporting. The record does not provide those details beyond the reported at-risk counts and event counts. The counts should therefore be read descriptively, not as a formal test of comparative safety.
Finally, the registry lists four outcome measures and four analyses, while the primary outcome description covers more than one assessment context. Multiple outcomes or assessment points can raise multiplicity concerns because making several statistical comparisons can increase the chance of at least one apparently notable result. In general, investigators may prespecify a primary comparison or use adjustment strategies; the statistical plan and any multiplicity adjustment are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and four analyses. It identifies child anxiety measured by mYPAS as the primary outcome, and lists secondary outcomes concerning caretaker anxiety, healthcare professional opinions about BERT, and patient induction compliance. The primary description includes mean change from baseline during induction and upon operating-room entry. The record does not reduce these assessment contexts to a single comparison.
In general, examining multiple outcomes or multiple timepoints creates a multiplicity issue: the more comparisons considered, the greater the chance that at least one result may appear notable by chance. Prespecifying a primary contrast, defining a hierarchy among outcomes, or applying a statistical adjustment can help address this concern. The registry record does not report whether a multiplicity strategy was planned or used, which comparisons were prioritized, or how the four analyses relate to the listed outcomes.
Missing-data procedures and analysis populations are also not reported in the registry record. It does not state how missing mYPAS observations were handled, whether the primary analysis followed an intention-to-treat principle, or which participants were included in each analysis. The recorded enrollment and the at-risk counts in the safety record do not establish the denominators used for the primary endpoint analyses. No participant flow or reasons for missing assessments are reported in the registry record.
These omissions matter because estimates can depend on who contributed data and how incomplete measurements were addressed. They also limit the ability to judge whether the primary analyses corresponded to the original randomized groups or whether exclusions could affect interpretation. Without those details and numerical endpoint results, the robustness of the primary comparison cannot be assessed from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Interactive Gaming Group | 0 | 74 | 0.0% |
| Standard of Care | 0 | 74 | 0.0% |
| Healthcare Professionals | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Interactive Gaming Group | 0 of 74 |
| Standard of Care | 0 of 74 |
| Healthcare Professionals | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Interactive Gaming Group | 0 of 74 |
| Standard of Care | 0 of 74 |
| Healthcare Professionals | 0 of 30 |
The registry reports adverse-event counts for the Interactive Gaming Group, the Standard of Care group, and Healthcare Professionals. For the Interactive Gaming Group, 0 serious adverse events were reported among 74 at risk, 0 other adverse events among 74 at risk, and deaths were 0. For the Standard of Care group, 0 serious adverse events were reported among 74 at risk, 0 other adverse events among 74 at risk, and deaths were 0. For Healthcare Professionals, 0 serious adverse events were reported among 30 at risk, 0 other adverse events among 30 at risk, and deaths were 0.
These are descriptive counts in the registry record. They do not establish that no events occurred outside the recorded categories or observation period. The record does not report event definitions, the duration of safety follow-up, ascertainment procedures, or whether events were judged related to the intervention. It also does not provide a comparative statistical analysis of these counts.
At-risk counts should not be interpreted as the denominators for the primary anxiety analyses. Nor do zero recorded events establish equivalent safety between groups. They describe what was entered in the registry’s adverse-event record; fuller interpretation would require information about monitoring and completeness that is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of an interactive gaming platform used before and during anesthesia induction against standard care without access to that system. It identifies the mYPAS as the primary measure of child anxiety and specifies the assessment contexts. Those details clarify what the trial was designed to investigate.
The primary numerical results are not reported in the registry record. Consequently, the record does not establish whether mean anxiety change differed between groups, how large any difference was, or how precisely it was estimated. The direction and statistical significance of the primary comparison cannot be determined from the endpoint description or study completion status.
This absence of a reported primary estimate should not be interpreted as a finding of no effect, nor as evidence of a benefit. It indicates that the information needed to evaluate the primary comparison is not reported in the registry record. The descriptive safety counts likewise cannot establish comparative safety, particularly without details about ascertainment and follow-up.
More generally, a trial estimate is not by itself a complete account of clinical importance. Interpretation ordinarily considers the magnitude and uncertainty of the estimated difference, the outcome’s meaning, the analysis population, missing data, and the study procedures. In this record, several of those details are not reported. No treatment recommendation follows from the information in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it frames a behavioral and device-based intervention as a randomized comparison with a defined usual-care comparator. Random allocation can support a fair comparison by reducing systematic differences between groups on average, although the registry record does not describe sequence generation, concealment, or implementation details. The presence of a randomized design does not remove the need to examine the analysis and outcome reporting.
The primary outcome also illustrates the role of measurement in clinical research. mYPAS converts observed behaviors into a score with a stated range and direction, allowing anxiety to be summarized and compared. Assessments around operating-room entry and induction focus the question on perioperative timepoints. At the same time, multiple assessment contexts require clear specification of which comparison is primary and how multiplicity is handled; those details are not reported in the registry record.
The registry’s inclusion of caretaker anxiety, professional opinions, and induction compliance reflects distinct kinds of outcomes, not interchangeable measures of child anxiety. An observed child score, a caretaker questionnaire, a professional survey, and a compliance checklist each address a different construct. Keeping those distinctions clear is important when interpreting a set of outcomes.
Finally, the record highlights the difference between trial completion, planning calculations, and reported evidence. A completed study and a planning illustration do not substitute for outcome estimates with uncertainty. Because the primary numerical results and key analysis details are not reported in the registry record, the statistical question remains unresolved by this record.
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.
A central limitation for interpretation is that the registry record does not report numerical results for the primary mYPAS endpoint. Without group summaries, a between-group estimate, or a measure of uncertainty, the size, direction, and precision of the primary comparison cannot be evaluated.
The endpoint is described at more than one assessment context, but the record does not identify a single comparison among them or report how these assessments were analyzed. Although four outcome measures and four analyses are listed, the statistical analysis plan and any multiplicity strategy are not reported. This limits the ability to determine how the primary question was prioritized or how findings across outcomes were intended to be interpreted.
The record labels the study double-masked without identifying who was masked or how masking was maintained. It also does not report details on random-sequence generation, allocation concealment, assessor training, or consistency of mYPAS scoring. These are relevant design and measurement details, not evidence that any particular problem occurred.
Analysis populations, missing-data handling, participant flow, and denominators for the primary outcome are not reported. The recorded enrollment and safety at-risk counts cannot fill those gaps. The record also does not describe which standard-care interventions were used, the duration of safety follow-up, or adverse-event ascertainment procedures. These limitations concern what can be learned from the registry record; they do not establish that the trial itself lacked the procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety — NCT06111742.
- Registry record last updated 2025-05-08; status last verified 2025-05.
- Results first posted 2025-05-08.
- 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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18. Record Summary
NCT06111742 is a completed randomized, double-masked, parallel-group trial sponsored by Yale University, with recorded enrollment of 178. The study compared interactive gaming through BERT directly before and during anesthesia induction with standard care without access to the gaming system.
The primary outcome was child anxiety measured with mYPAS, reported in the registry as mean change from baseline during induction and upon operating-room entry. The score ranges from 23 to 100, with higher scores indicating higher anxiety. Numerical primary results are not reported in the registry record. The registry lists secondary outcomes concerning caretaker anxiety, healthcare professional opinions, and induction compliance.
The adverse-event record reports zero serious events, zero other events, and zero deaths for each listed group. The registry does not report the primary analysis methods, analysis populations, missing-data procedures, or further safety follow-up details.