Statistical considerations

EE E. B. Elimimian
LE L. Elson
ES E. Stone
RB R. S. Butler
MD M. Doll
SR S. Roshon
CK C. Kondaki
AP A. Padgett
ZN Z. A. Nahleh
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This was a single-center, single-arm, non-controlled prospective pilot study. The primary endpoint of the trial was to evaluate the psychosocial therapeutic effects of one art therapy session on patient distress, depression, anxiety, and pain, using four VAS assessments. The VAS assessments were administered in-person, both prior-to (baseline) and immediately after the art therapy session, as well as by phone 48–72 h after the art therapy session. Therapeutic effects were evaluated as any change, between intervals, for each VAS assessment. Sample size calculations indicated a sample of 50 patients would allow a detection of a change in scores > 2.5 points with > 80% power and α < 0.05.

Normality testing was executed with Kolmogorov-Smirnov (KS) analyses (verified with Normal Q-Q plots), to determine the most appropriate paired testing method to suit the distribution characteristics of this data set.

A secondary goal was to utilize multivariable regression analyses to assess any association between trends in VAS scores and the independent demographic characteristics of our patient population. The independent variables of interest for multivariable analysis were race (white vs. non-white), ethnicity (Hispanic vs Non-Hispanic), marital status (married vs. not married), age (< 50 years, 50–69 years, ≥70 years), and gender (female vs. male). This modeling method was used for each VAS assessment.

All significance was determined by a threshold of α < 0.05. All statistics were performed using SPSS software (SPSS Statistics, Version 25.0: IBM Corp., Armonk, NY).

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