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

Abstract Background Some 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 reliev...

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Autores principales:	Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao, Xi Chen, Chang Su, Xuanyu Wu, Maolan Zhao, Sihan Hu, Hanwen Lin, Jiali Huang, Guo Xu, Qinxiu Zhang, Luyun Jiang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Auricular acupressure COVID-19 Vaccine Adverse events Randomized controlled trial Protocol Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/1f50b9ce7d53487f88d1cd513e73a45c
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spelling	oai:doaj.org-article:1f50b9ce7d53487f88d1cd513e73a45c2021-11-28T12:28:43ZAuricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial10.1186/s13063-021-05837-x1745-6215https://doaj.org/article/1f50b9ce7d53487f88d1cd513e73a45c2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05837-xhttps://doaj.org/toc/1745-6215Abstract Background Some 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. Methods The 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%. Discussion Results 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 registration China Clinical Trial Registry (ChiCTR) ( ChiCTR2100043210 ). Registered on 8 February, 2021.Qinwei FuHui XieLi ZhouXinrong LiYang LiuMin LiuChaoyu WangXiaocen WangZhiqiao WangJinfan TangHuan XiaoZhiyong XiaoJing ZhouChengzhi FengLi WangZhimin AoXi ChenChang SuXuanyu WuMaolan ZhaoSihan HuHanwen LinJiali HuangGuo XuQinxiu ZhangLuyun JiangBMCarticleAuricular acupressureCOVID-19VaccineAdverse eventsRandomized controlled trialProtocolMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Auricular acupressure COVID-19 Vaccine Adverse events Randomized controlled trial Protocol Medicine (General) R5-920
spellingShingle	Auricular acupressure COVID-19 Vaccine Adverse events Randomized controlled trial Protocol Medicine (General) R5-920 Qinwei Fu Hui Xie Li Zhou Xinrong Li Yang Liu Min Liu Chaoyu Wang Xiaocen Wang Zhiqiao Wang Jinfan Tang Huan Xiao Zhiyong Xiao Jing Zhou Chengzhi Feng Li Wang Zhimin Ao Xi Chen Chang Su Xuanyu Wu Maolan Zhao Sihan Hu Hanwen Lin Jiali Huang Guo Xu Qinxiu Zhang Luyun Jiang Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
description	Abstract Background Some 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. Methods The 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%. Discussion Results 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 registration China Clinical Trial Registry (ChiCTR) ( ChiCTR2100043210 ). Registered on 8 February, 2021.
format	article
author	Qinwei Fu Hui Xie Li Zhou Xinrong Li Yang Liu Min Liu Chaoyu Wang Xiaocen Wang Zhiqiao Wang Jinfan Tang Huan Xiao Zhiyong Xiao Jing Zhou Chengzhi Feng Li Wang Zhimin Ao Xi Chen Chang Su Xuanyu Wu Maolan Zhao Sihan Hu Hanwen Lin Jiali Huang Guo Xu Qinxiu Zhang Luyun Jiang
author_facet	Qinwei Fu Hui Xie Li Zhou Xinrong Li Yang Liu Min Liu Chaoyu Wang Xiaocen Wang Zhiqiao Wang Jinfan Tang Huan Xiao Zhiyong Xiao Jing Zhou Chengzhi Feng Li Wang Zhimin Ao Xi Chen Chang Su Xuanyu Wu Maolan Zhao Sihan Hu Hanwen Lin Jiali Huang Guo Xu Qinxiu Zhang Luyun Jiang
author_sort	Qinwei Fu
title	Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
title_short	Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
title_full	Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
title_fullStr	Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
title_full_unstemmed	Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
title_sort	auricular acupressure for adverse events following immunization related to covid-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/1f50b9ce7d53487f88d1cd513e73a45c
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Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial

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