Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial

Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin, Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin

Abstract

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 follow-up period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8-week 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.

Trial registration: ClinicalTrials.gov , Identifier: NCT03015766 . Registered on 22 December 2016.

Keywords: Auricular acupressure; Hemodialysis; Insomnia; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (No. B2016–137-01, date: 10 September 2016). This trial will be performed according to Ethical Principles of World Medical Association Declaration of Helsinki (Version Fortaleza 2013). All subjects will receive appropriate treatment without exacerbation of their suffering. Written informed consent will be obtained from all participants (Additional file 4). The patients will be given adequate time to raise questions and to consider whether to participate in the study.

Consent for publication

All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial flow chart
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure. Timing of visits and data collection. Abbreviations: AA auricular acupressure, SAA sham auricular acupressure, PSQI Pittsburgh Sleep Quality Index
Fig. 3
Fig. 3
A demonstration of interventions in the trial. a A map of auricular acupoints commonly used. b Ear-press seed (Wang Bu Liu Xing) applied in this trial. c Acupoints of both groups in the trial

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