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Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial
Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.
Insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic sedative agents are often reluctantly prescribed with doses mounting up. Patients are concerned about drug dependence and drug-related adverse effects. As a non-drug therapy, auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is widely used to treat many conditions in China. The investigators had been applying AAT for MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD patients with insomnia to evaluate the effect and safety of AAT.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Guangzhou HEMC (Higher Education Mega Center) Hospital
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Guangzhou Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Guangzhou Charity Hospital
Guangzhou, Guangdong, China
Wuyi Hospital of Traditional Chinese Medicine
Jiangsu Sheng, Guangdong, China
Shenzhen Hospital of Traditional Chinese Medicine
Shebu, Guangdong, China
Start Date
May 1, 2017
Primary Completion Date
October 1, 2018
Completion Date
May 1, 2019
Last Updated
May 13, 2019
130
ACTUAL participants
auricular acupressure therapy
OTHER
sham auricular acupressure therapy
OTHER
Lead Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
NCT06807086
NCT06983080
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06567210