Effect of Baduanjin Qigong on Sleep Quality and Hyperarousal State in Adults With Chronic Insomnia: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic insomnia (CI) is a mind-body disease that is commonly defined as a state of having disturbed daytime activities due to poor nighttime sleep quality. Baduanjin qigong (BDJQG) is widely used for CI in China. However, there is little scientific evidence to evaluate its effects on the hyperarousal state, which is closely associated with improved sleep quality. OBJECTIVE: The objective of the trial is to assess the therapeutic effects of BDJQG on sleep quality in patients with CI. METHODS: A randomized controlled trial will be conducted on 86 patients, who will be divided into a BDJQG group and a cognitive behavioral therapy for insomnia group at a ratio of 1:1. Interventions in both groups will be given to the participants 7 times a week for 8 weeks, and the participants will be followed up for 4 weeks. The primary outcome is the change in the Pittsburgh Sleep Quality Index from baseline to week 8. The secondary outcomes are the changes in the Hyperarousal Scale, Insomnia Severity Index, Fatigue Scale-14, wrist actigraphy, salivary cortisol level, and functional magnetic resonance imaging from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle. RESULTS: This study was funded from January 2023. As of the submission of the manuscript, there were 86 participants. Data collection began in April 2023 and will end in January 2024. Data analysis is expected to begin in January 2024, with the publication of results expected in February 2024. CONCLUSIONS: This study will present data concerning the clinical effects of BDJQG on CI. The results will help to demonstrate whether 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 much-needed knowledge for complementary and alternative therapy for patients with CI. TRIAL REGISTRATION: China Clinical Registration Agency ChiCTR2300069241; https://chictr.org.cn/bin/project/ChiCTR2300069241. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53501.