Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial

Abstract Background Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating th...

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Autores principales:	Chong Guan, Ziji Cheng, Fangfang Xie, Ruiping Wang, Jing Zhang, Fei Yao, Min Fang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Chronic insomnia Traditional Chinese medicine Abdomen-rubbing qigong exercise Functional magnetic resonance imaging Randomized controlled trials Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/c50feb30ec4e4a4fbed261ddbb01c3c1
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spelling	oai:doaj.org-article:c50feb30ec4e4a4fbed261ddbb01c3c12021-11-08T11:03:12ZEfficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial10.1186/s13063-021-05528-71745-6215https://doaj.org/article/c50feb30ec4e4a4fbed261ddbb01c3c12021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05528-7https://doaj.org/toc/1745-6215Abstract Background Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI). Method/design This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control. Discussion The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE. Trial registration China Clinical Registration Agency ChiCTR1900028009 . Registered on 19 December 2019.Chong GuanZiji ChengFangfang XieRuiping WangJing ZhangFei YaoMin FangBMCarticleChronic insomniaTraditional Chinese medicineAbdomen-rubbing qigong exerciseFunctional magnetic resonance imagingRandomized controlled trialsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Chronic insomnia Traditional Chinese medicine Abdomen-rubbing qigong exercise Functional magnetic resonance imaging Randomized controlled trials Medicine (General) R5-920
spellingShingle	Chronic insomnia Traditional Chinese medicine Abdomen-rubbing qigong exercise Functional magnetic resonance imaging Randomized controlled trials Medicine (General) R5-920 Chong Guan Ziji Cheng Fangfang Xie Ruiping Wang Jing Zhang Fei Yao Min Fang Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
description	Abstract Background Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI). Method/design This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control. Discussion The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE. Trial registration China Clinical Registration Agency ChiCTR1900028009 . Registered on 19 December 2019.
format	article
author	Chong Guan Ziji Cheng Fangfang Xie Ruiping Wang Jing Zhang Fei Yao Min Fang
author_facet	Chong Guan Ziji Cheng Fangfang Xie Ruiping Wang Jing Zhang Fei Yao Min Fang
author_sort	Chong Guan
title	Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
title_short	Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
title_full	Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
title_fullStr	Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
title_full_unstemmed	Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
title_sort	efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/c50feb30ec4e4a4fbed261ddbb01c3c1
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Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial

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