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 Impact of Visual Arts Immersion (NCT05877976), a na na study. The primary outcome is Change in Cultural Awareness Scale (CAS) Score From Baseline to Month 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05877976 |
| Phase | NA |
| Condition | Cultural Competency, Personal Reflection |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 41 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
Registered nurses in an academic health system were enrolled. The registry record reports an enrollment of 41. It does not report further eligibility details or the characteristics of participants who completed the surveys.
Intervention
Participants received museum educator-led workshops introducing arts appreciation skills. The study description frames the intervention as a visual arts immersion intended to engage nurses with creative and observational skills.
Comparator
The study used a single-group model, with no like-for-like control group or randomized comparison. Baseline measurements serve as the stated reference point for the primary outcome, not as a concurrent control condition.
Primary question
The primary question was whether the mean Cultural Awareness Scale score changed between baseline and Month 6 among participating nurses. The scale concerns cultural awareness, sensitivity, knowledge and skills. The registry record does not report the mean change or its confidence interval, so the direction and precision of the observed change cannot be described.
3. Trial Design
This was a completed, single-group behavioral study titled “Impact of Visual Arts Immersion.” NYU Langone Health is listed as the sponsor. The registry record gives a start date of 2023-06-15, a primary completion date of 2024-03-21, and an enrollment of 41. The phase and allocation are recorded as NA, and masking is recorded as none. These features describe a study without a randomized control comparison; they do not establish how participants were selected or whether every enrolled participant completed each assessment.
The intervention was museum educator-led workshops for registered nurses, introducing arts appreciation skills. The study description states that the project sought to enhance engagement, coping and self-reflection through creative and observational skills. It describes pre- and post-intervention surveys: the Cultural Awareness Scale, which addresses cultural awareness, sensitivity, knowledge and skills, and the Interpersonal Reactivity Index, which measures aspects of empathy and related social and emotional characteristics. Qualitative feedback was also to be solicited at the end of the intervention through a REDCap survey.
The primary outcome is identified as change in mean Cultural Awareness Scale score from baseline to Month 6. The record counts two outcome measures, but numerical results for the primary measure are not reported in the registry record. Details about recruitment, workshop attendance, adherence, survey completion, and the timing of the other outcome are not reported in the registry record. A statistical analysis plan and a sample-size justification are also 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.
Overall Study
| Stage | Registered Nurses |
|---|---|
| STARTED | 41 |
| COMPLETED | 10 |
| NOT COMPLETED | 31 |
Reasons for not completing this period:
| Reason | Registered Nurses |
|---|---|
| Lost to Follow-up | 31 |
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 | Registered Nurses |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 49.2 (SD 16.75) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Cultural Awareness Scale (CAS) Score From Baseline to Month 6, measured over Baseline, Month 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the mean Cultural Awareness Scale score from baseline to Month 6. The registry describes the scale as a 36-item questionnaire assessing cultural awareness, sensitivity, knowledge and skills. Each item uses a 7-point response scale from “strongly disagree” to “strongly agree.” The total score ranges from 0-252; lower scores indicate less cultural awareness and higher scores indicate greater awareness.
A change score is intended to describe how the measured outcome differs between the stated assessment times. The mean summarizes the average score change across participants included in the analysis. The registry lists a 95% confidence interval as the measure of dispersion. In general, a confidence interval conveys uncertainty around an estimated effect; its width depends on the data and analysis. Neither the mean change nor its confidence interval is reported in the registry record, so the size, direction and precision of the primary result cannot be assessed.
The scale provides a structured way to quantify responses to questions about the study’s cultural-awareness construct. A score is a measure on that questionnaire, not a direct measure of every aspect of cultural competence or nursing practice. The registry record does not report how the scale was scored beyond the stated total-score range and interpretation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its assessment times, but does not report the numerical outcome. In particular, the mean change in Cultural Awareness Scale score and its 95% confidence interval are not reported in the registry record. Without those values, it is not possible to state whether the average score increased or decreased, how large any change was, or how precisely it was estimated. The record therefore does not support a quantitative interpretation of the primary endpoint.
The single-group design matters when interpreting any before-and-after change. A baseline score can describe participants before the workshops, and a later score can describe them at Month 6. A difference between those measurements would describe change over time in the assessed group. It would not, by itself, show what would have happened to similar nurses without the intervention. The registry record does not identify a concurrent comparison group, and the design is not a randomized comparison. Other influences over time cannot be separated from the intervention using a baseline-to-follow-up contrast alone.
The intended endpoint is a questionnaire score about cultural awareness, sensitivity, knowledge and skills. It is not itself a direct measurement of clinical practice, wellbeing, coping, or patient outcomes. Those broader aims appear in the study description, but the record does not provide results that establish whether they changed. The described surveys include the Interpersonal Reactivity Index, and qualitative feedback was planned, but their numerical or qualitative findings are not reported in the registry record.
The registry identifies a 95% confidence interval as the endpoint’s dispersion measure, but no interval limits are reported. In general, an interval is useful for judging the range of effect values compatible with the observed data under the analysis assumptions. Without the estimate and interval, neither the magnitude nor the statistical precision of a result can be evaluated. A p-value, test statistic, or other inferential result for the primary endpoint is also not reported in the registry record.
Consequently, the appropriate reading is limited to the study question and design: the study was intended to assess mean Cultural Awareness Scale change from baseline to Month 6 after visual arts workshops in a group of registered nurses. The posted record does not establish the observed change or its uncertainty. This distinction is important: an outcome being designated as primary does not mean its result is available, and the study’s intended aims are not evidence of an outcome.
9. Statistical Methods Explained
The registry describes a continuous endpoint summarized as a mean, with a 95% confidence interval. The actual estimate and interval are not reported in the registry record, and the statistical procedure used to produce them is not reported in the registry record. The concepts below are general explanations of how these methods are commonly interpreted, not claims about the study’s unreported analysis.
What does a mean change represent?
For a continuous measure, a mean describes the arithmetic average of the observed values in the analysis group. For a change endpoint, the underlying quantity is the difference between a participant’s score at the stated follow-up and that participant’s baseline score, with the group mean summarizing those individual changes. This paired framing accounts for the fact that measurements come from the same participants at different times. The registry names baseline and Month 6 as the primary assessment times, but does not report the participant-level data, the calculated mean change, or the exact analysis procedure.
A mean can offer a concise description of average change, but it does not show how changes varied across participants. Participants may have changes that differ in direction or magnitude while the average remains similar. A mean alone also does not describe the distribution of scores or identify whether a small number of observations strongly influence the average. Those details cannot be assessed from the registry record because participant-level results and additional descriptive statistics are not reported there.
How should a confidence interval be read?
In general, a confidence interval expresses uncertainty around an estimated quantity under a statistical model and its assumptions. A narrower interval indicates greater precision than a wider interval, while the interval’s position relative to no change can help readers understand which values are compatible with the estimate. A confidence interval is not a guarantee that the true effect falls within its limits. Its interpretation depends on how the estimate was calculated, the data used, and the assumptions of the method.
The primary endpoint lists a 95% confidence interval, but its limits are not reported in the registry record. It is therefore not possible to judge the interval’s width, whether it includes no change, or what range of changes the data are compatible with. The stated confidence level does not substitute for the missing estimate and interval.
Why does the single-group structure matter?
General statistical principle: repeated measurements from the same people can be analyzed as paired data, which uses information about each person’s baseline and follow-up scores. However, the particular method used for this study is not reported in the registry record. More importantly, even a carefully estimated average before-and-after change in a single group does not separate intervention-associated change from other changes occurring over time. A concurrent comparison group can help address that question, but the registry describes a single-group model and no like-for-like control comparison.
The registry records allocation as NA and masking as none. Those entries do not supply details of a statistical model or explain how scores were handled. The analysis plan, adjustment variables, treatment of repeated measures, and assumptions used for inference are not reported in the registry record. No particular modeling approach should be inferred from the endpoint’s mean and confidence-interval labels.
What does the scale’s range imply?
The Cultural Awareness Scale is described as a 36-item questionnaire with a total score ranging from 0-252. General principle: bounded scales have a minimum and maximum, so possible changes depend on a participant’s starting score. A mean change can summarize results on the stated scale, but it does not by itself establish that a change is meaningful in practice. The registry record does not report a threshold for meaningful change, a validation interpretation for change scores, or the observed distribution of baseline and follow-up scores.
General principle: questionnaire totals also represent responses to a measurement instrument, rather than a complete account of a broad concept. The scale’s stated content relates to cultural awareness, sensitivity, knowledge and skills. The score should be interpreted as a measure from that instrument, not as a direct measure of every intended outcome described in the study rationale.
What can the posted statistical information establish?
The registry identifies the endpoint type, summary measure, dispersion measure and timeframe. It does not report the estimated mean change, its confidence interval, a p-value, or a model specification. The registry also does not report an analysis population or the number of participants contributing paired measurements. Therefore, the endpoint definition can be explained, but a numerical effect or inferential conclusion cannot be reconstructed from the record.
The record’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such an illustration is a hypothetical planning exercise, not the trial’s design rationale and not observed power. The actual calculated planning values and the observed effect are not reported in the registry record. No sample-size justification for the single-group study is reported there.
10. Multiplicity, Missing Data and Analysis Populations
The registry record counts two outcome measures and no analyses. It identifies change in Cultural Awareness Scale score from baseline to Month 6 as the primary outcome. The study description also mentions the Interpersonal Reactivity Index and qualitative feedback, but the record does not report numerical results for those measures. The relationship between the two registered outcome measures and the described surveys is not detailed enough to determine a complete testing plan.
When a study evaluates multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable finding can increase. General statistical methods can address multiplicity through prespecified outcome hierarchies or adjusted testing procedures. Whether any such strategy was planned or used is not reported in the registry record. No adjustment method, testing hierarchy, or detailed statistical analysis plan is reported.
The registry does not report participant counts for the baseline and Month 6 assessments, survey completion, or exclusions from the endpoint analysis. Missing-data methods, imputation, and sensitivity analyses are not reported in the registry record. The reported enrollment of 41 does not establish how many participants contributed complete measurements or were included in an analysis.
The analysis population is also not reported in the registry record. It is not stated whether analyses were intended to include all enrolled participants, only participants who received workshops, or those with both measurements. These distinctions matter because the analyzed group can differ from the enrolled group. Without outcome-level denominators and analysis-population definitions, the completeness and representativeness of the endpoint results cannot be evaluated.
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 |
|---|---|---|---|
| Registered Nurses | 0 | 41 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Registered Nurses | 0 of 41 |
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 |
|---|---|
| Registered Nurses | 0 of 41 |
The registry reports 0 participants with serious adverse events among 41 at risk, 0 participants with other adverse events among 41 at risk, and 0 deaths. No serious adverse event terms are listed. These are the recorded event counts for the registered group of Registered Nurses.
In general, an adverse-event count describes events recorded under the registry’s reporting framework; it does not on its own establish whether an event was caused by an intervention. A zero count means no events of the reported category were recorded in the listed group. It does not establish that no unrecorded events occurred, or that there was no risk. The registry record does not provide further detail about event definitions, collection procedures, follow-up completeness, or attribution.
The at-risk counts do not establish how many participants completed every study activity or survey. Safety figures should therefore be read as the registry’s reported counts, not as a complete characterization of all possible harms or of intervention causality.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group study assessed visual arts workshops for registered nurses and designated mean change in Cultural Awareness Scale score from baseline to Month 6 as its primary outcome. It also describes surveys intended to assess cultural awareness and empathy-related characteristics, along with qualitative feedback. These details define the study’s question and measurement approach.
The record does not report the primary mean change or its 95% confidence interval. It therefore does not establish whether the average Cultural Awareness Scale score changed, the size or direction of any change, or the precision of an estimate. Numerical results for the other described measures are also not reported in the registry record. The study’s stated intention to enhance engagement, coping, self-reflection and practice should not be treated as an observed result.
Even if a before-and-after change were available, a single-group result would describe change over time among the analyzed participants. Without a concurrent control comparison, it would not isolate the intervention’s contribution from other influences. The design also cannot establish from the registry information whether workshop participation caused any change in questionnaire scores.
The endpoint measures a defined questionnaire construct and should not be extended automatically to broader outcomes such as clinical practice, nurse wellbeing, or patient outcomes. The registry does not report results for those broader outcomes. The reported zero counts for adverse events and deaths are safety observations in the registry record; they do not establish absence of all risk or provide causal evidence.
Thus, the defensible conclusion concerns the study’s design and intended measurement, not the effectiveness of the workshops. The posted record does not contain the outcome values needed to make a quantitative claim about change.
13. Why This Trial Matters Statistically
This study raises a relevant measurement question: whether a structured visual arts experience can be evaluated using a questionnaire about cultural awareness, sensitivity, knowledge and skills. The registry identifies a specific primary outcome and assessment timeframe, making clear what change the study was intended to describe. It also distinguishes a measured questionnaire score from broad aims such as engagement, coping and self-reflection.
Statistically, the single-group design is central to interpretation. Baseline and follow-up measurements can describe within-group change, but they do not provide the counterfactual comparison needed to separate intervention-associated change from changes that might occur over time for other reasons. This distinction is important when reading studies of educational or behavioral interventions, where participants and their surroundings may change during follow-up.
The record also illustrates why an endpoint definition is not the same as an outcome result. Naming a mean and a 95% confidence interval describes how the primary measure is intended to be summarized; without the estimate and interval, readers cannot assess magnitude or precision. Reporting outcome values, participant counts, missing-data handling and analysis methods would be necessary for a fuller statistical appraisal.
Finally, the planned use of more than one assessment approach raises questions about how outcomes and analyses were prioritized. The registry record does not report a testing hierarchy or multiplicity strategy. Clear reporting of these choices can help readers distinguish prespecified primary evidence from additional exploratory findings. The study is statistically informative as a design and measurement question, while its posted record leaves the quantitative outcome unanswered.
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 most direct limitation of the available record is that the primary numerical result is not reported in the registry record. The mean change in Cultural Awareness Scale score and its 95% confidence interval are absent, so effect direction, magnitude and precision cannot be assessed. Numerical results for the other described measures are also not reported in the registry record.
The single-group design has no like-for-like control comparison. Consequently, any measured change over time would not by itself distinguish an intervention-associated change from other influences. The record also lists masking as none. It does not report how outcome collection or scoring was conducted, so the potential influence of participant expectations or measurement procedures cannot be assessed.
Although enrollment is reported as 41, the registry does not report the number of participants with baseline and Month 6 scores, workshop attendance, survey completion, or the analysis population. Missing-data handling and sensitivity analyses are not reported in the registry record. It is therefore unclear how much of the enrolled group would contribute to a complete-case endpoint estimate.
Other details needed to interpret the study are not reported in the registry record, including eligibility criteria, participant characteristics, workshop delivery and adherence details, the statistical analysis plan, and a sample-size justification. The description names additional survey and qualitative-feedback methods, but their results and analysis procedures are not reported. These limitations restrict both assessment of the endpoint and the scope of conclusions that could be drawn from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Impact of Visual Arts Immersion — NCT05877976.
- Registry record last updated 2025-01-22; status last verified 2024-12.
- Results first posted 2025-01-22.
- 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.
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18. Record Summary
NCT05877976, “Impact of Visual Arts Immersion,” is listed as completed and sponsored by NYU Langone Health. The registry reports an enrollment of 41, a start date of 2023-06-15, and a primary completion date of 2024-03-21. The design is single-group, with no masking and no randomized comparison.
Registered nurses received museum educator-led visual arts workshops. The primary outcome is change in mean Cultural Awareness Scale score from baseline to Month 6; the scale’s total score ranges from 0-252. The registry record does not report the primary estimate or its 95% confidence interval. It also records 0 serious adverse events, 0 other adverse events, and 0 deaths among 41 at risk.