The Effectiveness of Electrical Vestibular Stimulation (VeNS) on Symptoms of Anxiety: Study Protocol of a Randomized, Double-Blinded, Sham-Controlled Trial

Abstract

<p>The prevalence of symptoms of anxiety is increasing, especially during the COVID-19 pandemic. A home use transdermal neurostimulation device might help to minimize the severity of anxiety disorder. To the best of our knowledge, there is no clinical trial using transdermal neurostimulation to treat individuals with symptoms of anxiety in Asia. This gives us the impetus to execute the first study which aims at evaluating the efficacy of Electrical Vestibular Stimulation (VeNS) on anxiety in Hong Kong. This study proposes a two-armed, double-blinded, randomized, sham-controlled trial including the active VeNS and sham VeNS group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 1-month (T3) and 3-month follow-up (T4). A total of 66 community-dwelling adults aged 18 to 60 with anxiety symptoms will be recruited in this study. All subjects will be computer randomised into either the active VeNS group or the sham VeNS group in a 1:1 ratio. All subjects in each group will receive twenty 30 min VeNS sessions during weekdays, which will be completed in a 4-week period. Baseline measurements and post-VeNS evaluation of the psychological outcomes (i.e., anxiety, insomnia, and quality of life) will also be conducted on all participants. The 1-month and 3-month follow-up period will be used to assess the long-term sustainability of the VeNS intervention. For statistical analysis, ANOVA with repeated measures will be used to analyze data. Missing data were managed with multiple mutations. The level of significance will be set to <em>p</em> < 0.05. Results of this study will be used to determine whether this VeNS device can be considered as a self-help technological device to reduce perceived anxiety in the general population in the community setting. This clinical Trial was registered with the Clinical Trial government, identifier: NCT04999709.</p>