Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial

Trials

Chaoyu Wang¹  Maolan Zhao¹  Guo Xu¹  Zhiyong Xiao¹  Jiali Huang¹  Sihan Hu¹  Chang Su¹  Li Wang¹  Zhimin Ao¹  Jinfan Tang¹  Chengzhi Feng¹  Min Liu²  Huan Xiao³  Jing Zhou³  Li Zhou⁴  Xuanyu Wu⁴  Zhiqiao Wang⁴  Yang Liu⁴  Hui Xie⁴  Xi Chen⁴  Xiaocen Wang⁴  Luyun Jiang⁴  Qinwei Fu⁴  Hanwen Lin⁴  Xinrong Li⁴  Qinxiu Zhang⁵ 

[1] Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, 610075, Chengdu, China;Du Jiang Yan Medical Center, 611830, Du Jiang Yan, China;Eye School of Chengdu University of Traditional Chinese Medicine, 610075, Chengdu, China;Hospital of Chengdu university of Traditional Chinese Medicine, Chengdu university of Traditional Chinese Medicine, 610075, Chengdu, China;Hospital of Chengdu university of Traditional Chinese Medicine, Chengdu university of Traditional Chinese Medicine, 610075, Chengdu, China;School of Medical and Life Sciences, Chengdu University of Traditional Chinese Medicine, 611137, Chengdu, China;

关键词: Auricular acupressure;    COVID-19;    Vaccine;    Adverse events;    Randomized controlled trial;    Protocol;   

DOI  :  10.1186/s13063-021-05837-x

来源: Springer

【 摘 要 】

BackgroundSome pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the efficacy of auricular acupressure (AA) therapy in preventing and relieving AEFI after injection of COVID-19 vaccine.MethodsThe study design is a randomized, multicentre, three-arm controlled, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled and assigned in the medical institutions randomly 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 and 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 as 5%.DiscussionResults of this trial will help to clarify the value of auricular acupressure therapy in preventing and relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine.Trial registrationChina Clinical Trial Registry (ChiCTR) (ChiCTR2100043210). Registered on 8 February, 2021.

【 授权许可】

CC BY