Abstract
BackgroundInsomnia 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/designThis 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.DiscussionThe 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 registrationChina Clinical Registration Agency ChiCTR1900028009. Registered on 19 December 2019.
Highlights
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
abdomen-rubbing qigong exercise (ARQE) is often used in the clinic of our research group; we found that this intervention is proved to be able to improve sleep quality and gastrointestinal function, which are strongly connected
Study design To evaluate the efficacy of ARQE, a clinical randomized controlled trial is designed, with both evaluators and participants blinded to the design
Summary
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. The purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). Chronic insomnia refers to a sleeping disorder characterized by frequent or persistent difficulty in falling asleep or staying asleep [1]. Patients with insomnia hardly feel satisfied with their sleep quality [2]. Chronic insomnia is a serious illness which can bring harms to physical and mental health of human beings and even economic development
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