Abstract

Since the outbreak of the coronavirus disease (COVID-19), face coverings are recommended to diminish person-to-person transmission of the SARS-CoV-2 virus. Some public debates concern claims regarding risks caused by wearing face masks, like, e.g., decreased blood oxygen levels and impaired cognitive capabilities. The present, pre-registered study aims to contribute clarity by delivering a direct comparison of wearing an N95 respirator and wearing no face covering. We focused on a demanding situation to show that cognitive efficacy and individual states are equivalent in both conditions. We conducted a randomized-controlled crossover trial with 44 participants. Participants performed the task while wearing an N95 FFR versus wearing none. We measured physiological (blood oxygen saturation and heart rate variability), behavioral (parameters of performance in the task), and subjective (perceived mental load) data to substantiate our assumption as broadly as possible. We analyzed data regarding both statistical equivalence and differences. All of the investigated dimensions showed statistical equivalence given our pre-registered equivalence boundaries. None of the dimensions showed a significant difference between wearing an FFR and not wearing an FFR.Trial Registration: Preregistered with the Open Science Framework: https://osf.io/c2xp5 (15/11/2020). Retrospectively registered with German Clinical Trials Register: DRKS00024806 (18/03/2021).

Highlights

  • For all following Two One-Sided Test of Equivalence (TOST) procedures, we employed equivalence boundaries of dz = ±0.45. This smallest effect size of interest (SESOI) translates to the absolute values of the equivalence boundaries reported in the following paragraphs

  • We hypothesized that wearing an filtering facepiece respirators (FFRs) while performing a demanding, cognitive task for 15 min does not statistically differ from completing the same task without an FFR

  • All metrics recorded with an FFP2 mask are statistically equivalent to not wearing a mask, given our pre-defined equivalence interval of dz = ±0.45

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Summary

Methods

The main task consisted of solving basic arithmetic equations (addition, subtraction, multiplication, or division) presented visually. Each equation was composed of two numbers (1 to 3 digits) and one operator. We decided to implement mental arithmetic because these tasks are suitable for inducing cognitive ­processing[58], and the task allows usto vary difficulty levels of the ­task[59,60]. This stimulus is suited to simulate office ­work[43,61]

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