Auricular Vagus Nerve Acupressure for Patients with Emotional Distress under the COVID-19 Pandemic: A Smartphone-based, Randomized，Controlled Trial (Preprint)

BACKGROUND The global spread of the 2019 coronavirus diseases (COVID-19) has caused emotional distress. However, whether auricular vagus nerve acupressure (AVNA) is effective in improving emotional distress under the COVID-19 has not been well-documented. OBJECTIVE To confirm whether AVNA is effective in improving emotional distress under the COVID-19 pandemic. METHODS A smartphone-based online, randomized, controlled trial was designed in four study sites, including Wuhan, Beijing, Shenyang, and Guangzhou of China, from 26 February 2020 to 28 April 2020. Participants were randomly assigned to three times of AVNA (n = 191) or usual care (UC, n = 215) for 14 days. The primary outcome was the response rate, which was the proportion of participants whose Hospital Anxiety and Depression Scale (HADS) score reduced from baseline by ≥ 50%. The assessment was conducted at baseline, 3 days, and 14 days. RESULTS The AVNA group had a markedly higher response rate than the UC group at 3 days (35.6% vs. 24.9%, P = 0.02) and at 14 days (70.7% vs. 60.6%, P = 0.02). The AVNA group showed significantly greater reduction in score of HADS at the two measurement points and BAI at 3 days (P ≤ 0.03), with average respective effect size of 0.217 and 0.195. Participants with AVNA spent less time falling asleep and rated their sleep quality being remarkably higher than those with UC at endpoint. CONCLUSIONS AVNA can be recommended for patients with emotional distress under the current COVID-19 pandemic and other emergent events. CLINICALTRIAL www.chictr.org.cn Identifier: ChiCTR2000030078.