References
Anxiety, sleep disturbance, drowsiness, anxiety, grogginess, pain
REGRESSION, SIDE EFFECTS
Study flow diagram. Eligible participants were enrolled in the study and randomized into one of three groups: Sleep A, Sleep B, or placebo. We collected baseline clinical measures before participants started using their study product. Participants used study product for 4 weeks total. Clinical and other measures were collected at the end each week as well as 1 week post study product use.Evolution of PROMIS sleep disturbance 8a between the three arms during the study period. The plot illustrates the interaction between treatment (Sleep A; Arm 1 and Sleep B; Arm 2) and week on the sleep disturbance scale based on a linear mixed-effects model. The Evolution of PROMIS Anxiety 4a scores between the three arms during the study period. The plot illustrates the interaction between treatment (Sleep A; Arm 1 and Sleep B; Arm 2) and week on the anxiety scale, based on a linear mixed-effects model. The Evolution of PROMIS Stress 4a between the three-arms during the study period. The plot illustrates the interaction between treatment (Sleep A; Arm 1 and Sleep B; Arm 2) and week on the stress scale, based on a linear mixed-effects model. The Evolution of PEG scores between the three arms during the study period x. The plot illustrates the interaction between treatment (Sleep A; Arm 1 and Sleep B; Arm 2) and week on EG scores, based on a linear mixed-effects model. The Evolution of WHO well-being scores between the three arms during the study period x. The plot illustrates the interaction between treatment (Sleep A; Arm 1 and Sleep B; Arm 2) and week on the well-being scale, based on a linear mixed-effects model. The Comparison of side effects between active arms (Sleep A; Arm 1 and Sleep B; Arm 2) and placebo. This figure displays the occurrence of side effects in the active arms (Sleep A; Arm 1 and Sleep B; Arm 2) compared to the placebo group. Participants with sleep disturbance received Sleep A (Arm 1), Sleep B (Arm 2), or placebo for 4 weeks. Side effects, primarily grogginess and drowsiness, were slightly more common in the active arms but were mild and non-serious, requiring no emergency or non-emergency healthcare services.Validated measures for key outcomes used in Radicle Rest study.Participant sample summary at baseline.Significant factors associated with sleep disturbance: results from a linear mixed-effects regression model. Summary of significant variables and their associations with sleep disturbance based on a linear mixed-effects regression model. The model was used to assess the differences in the change in the variables of interest between each active product arm versus placebo. The table presents the beta coefficients (β), standard errors (Std.Error), degrees of freedom (DF), t-values, and Significant factors associated with anxiety: results from a linear mixed-effects regression model. Summary of significant variables and their associations with anxiety based on a linear mixed-effects regression model. The model was used to assess the differences in the change in the variables of interest between each active product arm versus placebo. The table presents the beta coefficients (β), standard errors (Std.Error), degrees of freedom (DF), t-values, and Significant factors associated with stress: results from a linear mixed-effects regression model. Summary of significant variables and their associations with stress based on a linear mixed-effects regression model. The model was used to assess the differences in the change in the variables of interest between each active product arm versus placebo. The table presents the beta coefficients (β), standard errors (Std.Error), degrees of freedom (DF), t-values, and Significant factors associated with pain: results from a linear mixed-effects regression model. Summary of significant variables and their associations with pain based on a linear mixed-effects regression model. The model was used to assess the differences in the change in the variables of interest between each active product arm versus placebo. The table presents the beta coefficients (β), standard errors (Std.Error), degrees of freedom (DF), t-values, and Significant factors associated with overall well-being: results from a linear mixed effects regression model. Summary of significant variables and their associations with overall well-being based on a linear mixed-effects regression model. The model was used to assess the differences in the change in the variables of interest between each active product arm versus placebo. The table presents the beta coefficients (β), standard errors (Std.Error), degrees of freedom (DF), t-values, and 