Effectiveness of music with auditory beat stimulation in reducing state anxiety in Canadian students with trait anxiety: protocol for a randomised controlled trial.

introductionUndergraduate students report a high level of trait anxiety, which is a risk factor for further psychological decline if unmanaged. Music-based interventions are cost-effective and have been found to improve indices of anxiety. More recently, music with auditory beat stimulation (ABS) has been shown to improve symptoms of anxiety to a greater extent than music alone. While there is limited empirical evidence, music interventions with ABS may also be effective at targeting neurophysiological markers of anxiety. The aim of this study is to evaluate the effectiveness of a novel music with ABS intervention on self-report and neurophysiological indices of anxiety in undergraduate students with trait anxiety. It is hypothesised that relative to a pink noise control, listening to music with ABS will lower self-reported anxiety, reduce salivary cortisol, increase heart rate variability, increase theta and alpha-band electroencephalography (EEG) power and decrease beta and gamma-band EEG power. METHODS AND ANALYSIS: Fifty Canadian undergraduate students who self-report experiencing anxiety will be recruited for this two-arm randomised controlled trial. Participants will be randomised to a single music session with ABS or pink noise; each intervention ranges from 24 min to 27 min. Outcomes will be assessed at baseline and immediately following the intervention and will be self-reported anxiety and affect (the State-Trait Inventory of Cognitive and Somatic Anxiety and the Self-Assessment Manikin), salivary cortisol, heart rate variability measured by ECG and cortical measures of anxiety (measured by EEG). Repeated measures analyses of covariance will be performed to evaluate the effect of condition assignment on outcome measures. ETHICS AND DISSEMINATION: This study will be conducted under the Declaration of Helsinki. This study was approved by the Toronto Metropolitan University Research Ethics Board (REB-2020-068) and registered on ClinicalTrials.gov (NCT05442086). The findings of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05442086.