机构:[1]Hemodialysis Department, Guangdong Provincial Hospital of ChineseMedicine, Guangzhou, People’s Republic of China[2]Second Clinical MedicalCollege, Guangzhou University of Chinese Medicine, Guangzhou, People’sRepublic of China[3]Evidence-based Medicine and Clinical Research ServiceGroup, Guangdong Provincial Academy of Chinese Medical Sciences,Guangzhou, People’s Republic of China广东省中医院[4]Hemodialysis Department,Guangzhou Charity Hospital, Guangzhou, People’s Republic of China[5]Hemodialysis Department, Guangzhou HEMC (Higher Education MegaCenter) Hospital, Guangzhou, People’s Republic of China[6]HemodialysisDepartment, Guangzhou Hospital of Traditional Chinese Medicine,Guangzhou, People’s Republic of China[7]Hemodialysis Department,Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, People’s Republic of China深圳市康宁医院深圳医学信息中心[8]Hemodialysis Department, Wuyi Hospital of TraditionalChinese Medicine, Jiangmen, People’s Republic of China
Background: Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia. Methods/design: The proposed study is a multi-center, double-blind (participants and assessors), parallel-group RCT. A total of 112 participants with insomnia will be recruited from six hemodialysis centers in Guangzhou, China, and randomly allocated in a 1: 1 ratio to receive auricular acupressure on either active points (AA group) or control points (points irrelevant to insomnia management, SAA group). The treatment will last for 8 weeks prior to a followup period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8week and 12-week follow-ups (after intervention) will include Pittsburgh Sleep Quality Index (PSQI) scores and average weekly dose of hypnotics. The primary endpoint is clinical response rate (percentage of participants who reach a reduction of PSQI global score >= 3 in each group) at 8 weeks from baseline. Secondary endpoints include the changes in PSQI scores over time from baseline, as well as the changes in weekly dose of hypnotics. Discussion: This paper describes the rationale and design of a double-blind RCT that aims to determine the efficacy and safety of AAT for insomnia of hemodialysis patients. If successful, this project will provide evidence of the efficacy and safety of AAT for insomnia of hemodialysis patients.
基金:
TCM Research Project of Guangdong Provincial Hospital of Chinese Medicine [YN2015MS25]; MOST/SATCM of the People's Republic of China [2013BAI02B04]; State Administration of Traditional Chinese Medicine, P.R. China [201007005]
第一作者机构:[1]Hemodialysis Department, Guangdong Provincial Hospital of ChineseMedicine, Guangzhou, People’s Republic of China[2]Second Clinical MedicalCollege, Guangzhou University of Chinese Medicine, Guangzhou, People’sRepublic of China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Wu Yuchi,Yang Lihong,Li Lingli,et al.Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial[J].TRIALS.2018,19:doi:10.1186/s13063-018-2546-2.
APA:
Wu, Yuchi,Yang, Lihong,Li, Lingli,Wu, Xiuqing,Zhong, Zhicong...&Lin, Qizhan.(2018).Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial.TRIALS,19,
MLA:
Wu, Yuchi,et al."Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial".TRIALS 19.(2018)