Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 17, 2023
Open Peer Review Period: Oct 9, 2023 - Dec 4, 2023
Date Accepted: Nov 23, 2023
(closed for review but you can still tweet)
Effect of Baduanjin Qigong on sleep quality and hyperarousal state in adults with chronic insomnia: protocol for a randomized controlled trial
ABSTRACT
Background:
Chronic insomnia (CI) is a mind-body disease which is commonly defined as a state of having disturbed daytime activities due to poor night-time sleep quality. Baduanjin Qigong is widely used for chronic insomnia in China. But there is little scientific evidence to evaluate its benefits on hyperarousal state which is closely associated with improve sleep quality.
Objective:
The aim of the trial is to assess the therapeutic effects of BDJQG on sleep quality and in patients with CI.
Methods:
A randomized controlled trial (RCT) consisting of 86 patients will be divided into a BDJQG or Cognitive Behavioral Therapy for Insomnia (CBTI) group in a ratio of 1:1. Interventions in both groups will be given to all participants 7 times a week for 8 weeks, followed up for 4 weeks. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. The secondary outcomes are the change in Hyperarousal Scale (HAS), Insomnia Severity Index (ISI), Fatigue scale-14 (FS-14), wrist actigraphy, Salivary Cortisol Level (SCL), and functional Magnetic Resonance Imaging (fMRI) from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle.
Results:
NONE
Conclusions:
The study will present data concerning the clinical effects of treating chronic insomnia with BDJQG. The results will help to demonstrate if BDJQG is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. This study will provide clinicians much needed knowledge for a complementary and alternative therapy for patients with CI. Clinical Trial: China Clinical Registration Agency ChiCTR2300069241. Registered on 10 March, 2023.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.