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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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626745/ https://www.ncbi.nlm.nih.gov/pubmed/34838110 http://dx.doi.org/10.1186/s13063-021-05837-x |
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author | Fu, Qinwei Xie, Hui Zhou, Li Li, Xinrong Liu, Yang Liu, Min Wang, Chaoyu Wang, Xiaocen Wang, Zhiqiao Tang, Jinfan Xiao, Huan Xiao, Zhiyong Zhou, Jing Feng, Chengzhi Wang, Li Ao, Zhimin Chen, Xi Su, Chang Wu, Xuanyu Zhao, Maolan Hu, Sihan Lin, Hanwen Huang, Jiali Xu, Guo Zhang, Qinxiu Jiang, Luyun |
author_facet | Fu, Qinwei Xie, Hui Zhou, Li Li, Xinrong Liu, Yang Liu, Min Wang, Chaoyu Wang, Xiaocen Wang, Zhiqiao Tang, Jinfan Xiao, Huan Xiao, Zhiyong Zhou, Jing Feng, Chengzhi Wang, Li Ao, Zhimin Chen, Xi Su, Chang Wu, Xuanyu Zhao, Maolan Hu, Sihan Lin, Hanwen Huang, Jiali Xu, Guo Zhang, Qinxiu Jiang, Luyun |
author_sort | Fu, Qinwei |
collection | PubMed |
description | 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 | Online Article Text |
id | pubmed-8626745 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-86267452021-11-29 Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial Fu, Qinwei Xie, Hui Zhou, Li Li, Xinrong Liu, Yang Liu, Min Wang, Chaoyu Wang, Xiaocen Wang, Zhiqiao Tang, Jinfan Xiao, Huan Xiao, Zhiyong Zhou, Jing Feng, Chengzhi Wang, Li Ao, Zhimin Chen, Xi Su, Chang Wu, Xuanyu Zhao, Maolan Hu, Sihan Lin, Hanwen Huang, Jiali Xu, Guo Zhang, Qinxiu Jiang, Luyun Trials Update 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. BioMed Central 2021-11-27 /pmc/articles/PMC8626745/ /pubmed/34838110 http://dx.doi.org/10.1186/s13063-021-05837-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Update Fu, Qinwei Xie, Hui Zhou, Li Li, Xinrong Liu, Yang Liu, Min Wang, Chaoyu Wang, Xiaocen Wang, Zhiqiao Tang, Jinfan Xiao, Huan Xiao, Zhiyong Zhou, Jing Feng, Chengzhi Wang, Li Ao, Zhimin Chen, Xi Su, Chang Wu, Xuanyu Zhao, Maolan Hu, Sihan Lin, Hanwen Huang, Jiali Xu, Guo Zhang, Qinxiu Jiang, Luyun 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 | 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_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_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 |
topic | Update |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626745/ https://www.ncbi.nlm.nih.gov/pubmed/34838110 http://dx.doi.org/10.1186/s13063-021-05837-x |
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