ABSTRACT
Background: Some pain, fatigue, and gastrointestinal adverse reactions were observed in potential association with injection of COVID-19 vaccines. However, there were no preventive intervention for it. We aim to investigate efficacy of auricular acupressure (AA) therapy in preventing and (or) relieving AEFI after injection of COVID-19 vaccine. Methods/design: The study design is a randomized controlled, multicentre, three-arm, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled, and assigned randomly in the medical institutions for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group and wait-list group. Interventions will be performed immediately, and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline, 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined at the 5 % level. Discussion Results of this trial will help clarify the value of auricular acupressure therapy in preventing and (or) relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration: This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021.