Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice (NCT06554431), a na na study. The primary outcome is Feasibility of the Intervention.

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group behavioral study of self-driven repetitive artmaking. The named intervention is Self-Driven Repetitive Artmaking, and the arm is described as Art Making. Each patient will receive artmaking kits, according to the arm description. The registry lists enrollment as 31. It does not describe a randomized allocation process or a separate comparison arm; allocation is listed as NA and the model as SINGLE GROUP. Masking is listed as NONE.

The listed study start date is 2024-07-02, and the primary completion date is 2025-01-05. The status is COMPLETED, and the phase is listed as NA. These registry fields describe the study record, but do not give details about recruitment, intervention delivery, adherence monitoring, or the timing of individual assessments. The exact schedule for the pre- and post-surveys is not reported in the registry record.

The primary purpose is to assess acceptability, expressed operationally as whether participants undertake the practice on their own. The primary outcome measures feasibility using the number of patients completing pre- and post-surveys up to four (4) times over a 4 months timeframe. Secondary outcomes address mood, pain, pain catastrophizing, social connectivity, and non-prescribed opioid use. The record lists 11 outcome measures and 25 analyses, but does not provide the analysis methods or outcome estimates in the information available for interpretation.

Because there is no like-for-like control group, the study is descriptive and exploratory rather than a randomized comparison. Survey completion can inform whether the study procedures and practice were workable for participants, but any observed change in mood or pain would not, by itself, establish that the artmaking caused that change. The registry record does not report a sample-size justification or details of any planned interim analyses.

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 Feasibility of the Intervention, measured over 4 months.

The primary endpoint is titled Feasibility of the Intervention. It is defined as the number of patients who complete the pre- and post-survey up to four (4) times, within a 4 months timeframe. The unit is participants, and the registry describes the result as a summary count. This operationalizes feasibility through survey completion: it records whether participants reach the specified assessment points, rather than directly measuring artistic skill, satisfaction, or clinical benefit.

Completion is useful in a feasibility study because it can indicate whether participants are able and willing to engage with study procedures over the planned period. In this study, it is also relevant to the stated interest in whether people will undertake self-directed artmaking. However, survey completion and practice engagement are not identical. A participant might complete surveys without doing the practice, or do the practice without completing every survey. The registry record does not report a separate measure of practice frequency or adherence.

The endpoint description does not specify how partial completion is handled, whether each survey occasion contributes separately, or how missing assessments are treated. The registry record also does not report the observed completion count or a corresponding estimate of uncertainty. Without those details and results, the endpoint definition can be interpreted, but the degree of feasibility observed cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is a participant count: the number completing the specified pre- and post-surveys during the 4 months timeframe. A count answers a practical question about how many participants met the completion criterion. To interpret it, readers need to know exactly how completion was defined and which participants were included in the denominator. The registry record gives the endpoint description and enrollment of 31, but does not report the observed completion count, a denominator for the primary analysis, or rules for handling partial surveys.

Counts can be presented alone, but an estimate of a completion proportion can also be useful when the eligible denominator is clear. That proportion would indicate the share of the relevant group meeting the criterion. No such result is reported in the registry information available for interpretation, and no proportion should be inferred from enrollment alone. A count of people completing surveys is also distinct from a count of completed survey occasions; the endpoint description does not explain whether repeated completion occasions are analyzed separately or combined into a participant-level summary.

For continuous outcomes such as mood or pain scores, an analysis might describe values at each assessment or estimate change between assessments. A change estimate would need to be paired with an uncertainty measure, such as a confidence interval, to show how precisely it is estimated. For binary outcomes, results may be expressed as counts of participants with an event, with the denominator and uncertainty made explicit. These are general statistical approaches, not methods confirmed for this study. The registry record does not specify the score summaries, statistical models, or uncertainty measures used for its secondary outcomes.

Repeated observations from the same person are related, rather than independent. General methods for repeated measurements account for this within-person dependence when estimating change or describing patterns over time. The record refers to surveys up to four (4) times, but it does not state the exact assessment schedule or whether the analysis used a repeated-measures model. It also does not report how participants with incomplete follow-up contribute to each analysis. Without these details, the analytic handling of repeated measures cannot be assessed.

Missing data matter because participants who complete later surveys may differ from those who do not. If completion is related to symptom severity, intervention experience, or other characteristics, results among survey completers may not represent all enrolled participants. This is a general concern in longitudinal studies, not a claim about what happened in this study. The registry record does not report missing-data counts, reasons for missingness, imputation, or sensitivity analyses. A complete-case estimate, if used, would require particular caution, but the analysis approach is not reported.

The registry lists 11 outcome measures and 25 analyses. When many outcomes or analyses are examined, the chance of finding an apparently notable result by chance can increase. General approaches to multiplicity include prespecifying a primary outcome, adjusting inference across a defined family of tests, or treating secondary analyses as exploratory. The record identifies a primary feasibility endpoint and secondary outcome domains, but does not report a multiplicity strategy, a hierarchy among secondary outcomes, or which analyses were designated confirmatory.

The sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. This illustration is not the study's single-group design: the registry lists no randomized comparison and does not report a sample-size justification for the actual study. Planning values, where shown, should be read as hypothetical design calculations, not as observed power or evidence that the study could detect a particular effect. No numerical planning values are reported in the information available for this interpretation.

Finally, statistical significance and practical importance are different questions. A test result alone does not describe the size of a change, its uncertainty, or whether the change matters to participants. For a feasibility study, the completion criterion and observed completion pattern are central; for secondary outcomes, estimates and uncertainty are needed to understand what the data can support. Those outcome results and analysis details are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Art Making")
n      <- c(31)
events <- c(25)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Art Making  31  25  80.6  62.5  92.5  63.7  90.8  63.6  90.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures and 25 analyses. It identifies feasibility as the primary endpoint and lists mood, pain, pain catastrophizing, social connectivity, and non-prescribed opioid use as secondary outcome areas. Examining multiple outcomes can raise a multiplicity concern: the more comparisons made, the greater the opportunity for some results to appear notable by chance. This is a general statistical issue, not evidence that any particular finding in this study is spurious.

The registry record does not report whether the analyses were prespecified in a detailed statistical plan, how the 25 analyses were grouped, whether any adjustment for multiple testing was used, or which secondary findings were intended to be confirmatory rather than exploratory. Without that information and the outcome results, the strength of evidence across the many outcomes cannot be evaluated. Secondary outcomes are best interpreted as exploratory unless the analysis plan establishes otherwise.

The record also does not report the extent or reasons for missing survey data, the number included in each analysis, rules for partial completion, or any imputation or sensitivity analysis. These details matter because survey completion is itself the primary feasibility measure, while missing follow-up can also affect estimates for mood and pain. The analysis populations are not defined in the registry information available for interpretation. Enrollment of 31 should not be treated as the denominator for every outcome analysis without confirmation that all enrolled participants were included.

As a general principle, missing-data methods depend on why observations are missing and on the assumptions used to model them. No such assumptions or methods are reported in the registry record. Consequently, neither the impact of missingness nor the robustness of any outcome estimate can be assessed from the information available.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

For the Art Making group, the registry lists 31 participants at risk, 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. No serious adverse event terms are listed. These are registry counts, not a comparison between treatment groups; the study has a single-group design.

A recorded count of 0 means that the registry reports no affected participants in that category for the group. It does not demonstrate that no unwanted experiences occurred in any broader sense, nor does it establish that the intervention has no risk. The record does not provide event descriptions, observation windows, severity details beyond the serious-event category, or information about how actively events were collected. It also does not report whether events led to discontinuation or whether all participants had the same duration of safety observation.

Safety counts should therefore be read as a limited description of the events recorded for this study, not as a complete assessment of safety or a comparison against an alternative. The registry record does not report enough detail to characterize event patterns or estimate comparative risks.

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

The record establishes that a completed, single-group study was registered to evaluate self-driven repetitive artmaking for people with chronic pain and opioid use disorder or opioid misuse. It describes an artmaking-kit intervention and identifies survey completion as the primary feasibility measure. These features clarify the study's purpose and design, but do not by themselves show whether participants completed the surveys or undertook the art practice as intended.

The stated secondary questions concern anxiety, depression, pain, pain catastrophizing, social connectivity, and non-prescribed opioid use. The registry information available for interpretation does not report results for these outcomes. It therefore cannot show whether any outcome improved, worsened, or remained similar, or how precise any estimated change might be. The listed outcome domains are questions under study, not evidence of benefit or harm.

The single-group design is important to the meaning of any before-and-after results. Even if a change were reported, a change over time alone would not distinguish an effect of artmaking from other influences. Without a control group, the study cannot make a like-for-like estimate of what would have happened over the same period without the intervention. The record also does not provide details about concurrent care or other factors that could influence outcomes.

The primary endpoint is a practical feasibility measure, but survey completion is not interchangeable with participant satisfaction or sustained practice. The registry does not report a separate adherence measure or a qualitative account of participants' experiences. As a result, the endpoint definition should not be taken to answer every aspect of acceptability.

The adverse-event record lists 0 affected participants for serious and other events and 0 deaths. These counts are limited to what is recorded and do not establish the absence of all risks. Overall, the registry record describes the questions and design, but the outcome data needed to judge feasibility, clinical changes, and their precision are not reported.

14. Why This Trial Matters Statistically

Feasibility studies address whether an intervention and its evaluation procedures can be carried out in the intended population. That question can be important before a larger or more definitive evaluation is considered. In this study, survey completion is the specified quantitative feasibility measure, while the stated primary purpose also asks whether participants will undertake self-directed artmaking. Keeping those concepts distinct helps readers understand what the endpoint can and cannot capture.

The design also illustrates why a study's question and comparison structure matter. A single-group study can describe participation and changes observed over time, but it does not provide a like-for-like control comparison. The findings, if reported, would need to be interpreted as exploratory rather than as a controlled estimate of an intervention effect. That distinction is especially relevant when mood, pain, and social outcomes are listed as secondary questions.

Statistically, a clear endpoint definition, transparent completion denominators, and an account of missing assessments are important for evaluating feasibility. For secondary outcomes, the reported estimates and uncertainty would help distinguish an informative pattern from an imprecise one. The registry lists 11 outcome measures and 25 analyses, making transparency about outcome selection and multiplicity relevant to interpretation. The analysis methods, missing-data handling, and multiplicity approach are not reported in the registry information available for interpretation.

The registry record makes the study's scope visible: artmaking kits, a chronic pain and opioid-related population, a single-group design, and a survey-completion endpoint. Its value as evidence for feasibility or clinical outcomes depends on the results and methods being available alongside that design description. Those results are not reported in the information available for this interpretation, so conclusions about what participants experienced or whether outcomes changed remain limited.

15. 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 main interpretive limitation is that the registry information available for interpretation does not report the observed primary endpoint or secondary outcome results. Without completion counts, outcome estimates, or uncertainty measures, readers cannot assess the degree of feasibility, the direction or size of any changes, or their precision.

The single-group design does not provide a like-for-like control comparison. Any pre- and post-intervention change, if reported elsewhere, could reflect influences other than artmaking. The registry record does not provide enough information about concurrent care, other time-related influences, or participant characteristics to assess their role.

The operational feasibility endpoint is based on survey completion, while the stated interest includes whether participants undertake the practice on their own. The record does not report a separate measure of artmaking frequency, the definition of adequate engagement, or how adherence was assessed. Survey completion alone may not capture those aspects of acceptability.

Key details about the assessment schedule, eligibility criteria, recruitment, intervention delivery, and support are not reported in the registry record. Nor are the analysis populations, missing-data methods, or handling of partial survey completion described. These omissions limit assessment of who contributed to each result and whether missing observations could affect interpretation.

The record lists 11 outcome measures and 25 analyses, but does not report a multiplicity approach or a detailed statistical analysis plan. The safety counts are also limited: no event descriptions or collection details are reported. These limitations do not establish that methods were inadequate; they indicate what cannot be evaluated from the registry information available.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice — NCT06554431.
• Registry record last updated 2026-03-03; status last verified 2026-02.
• Results first posted 2026-03-03.
• 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.

19. Record Summary

The registry record describes NCT06554431, Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice, sponsored by Montefiore Medical Center. It is a completed, single-group behavioral study with enrollment listed as 31. The intervention is self-driven repetitive artmaking, with artmaking kits described for the Art Making group. The listed start date is 2024-07-02, and the primary completion date is 2025-01-05.

The primary endpoint is feasibility, measured by the number of patients completing pre- and post-surveys up to four (4) times during a 4 months timeframe. Secondary outcomes concern anxiety, depression, pain, pain catastrophizing, social connectivity, and non-prescribed opioid use. The record lists 11 outcome measures and 25 analyses. It does not report the outcome estimates or the analysis methods needed to assess them.

For the Art Making group, the registry lists 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These are recorded counts and should be interpreted within the limits of the safety information reported.