Administrative information
Title {1} | Efficacy and safety of electroacupuncture treatment in the prevention of negative moods among healthy young men after 30 h of total sleep deprivation: study protocol for a single-center, single-blind, parallel-arm, randomized clinical trial |
Trial registration {2a and 2b}. | Chinese Clinical Trial Registry, Chi2000039713, registered on 06 November 2020. |
Protocol version {3} | Protocol version V1.1 dated 3 December 2020 |
Funding {4} | This research is funded by Chengyu Liu, the National Natural Science Foundation of China (grant number: 81973954) and Scientific Research and Development Foundation of Changchun University of Chinese Medicine. |
Author details {5a} | Bing Yan: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Fu-chun Wang: Department of Acupuncture, The Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China Tian-shu Ma: Innovative Practice Center, Changchun University of Chinese Medicine, Changchun, China Yan-ze Liu: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Wu Liu: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Lei Cheng: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Zi-yuan Wang: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Zhong-ke Wang: School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun, China Cheng-yu Liu: School of Rehabilitation Medicine, Changchun University of Chinese Medicine, Changchun, China |
Name and contact information for the trial sponsor {5b} | Sponsor: The Affiliated Hospital of Changchun University of Chinese Medicine, Gongnong Road No.1478, Chaoyang District, Changchun, China Coordinating Investigator (contact): Prof. Fuchun Wang Acupuncture Department, The Affiliated Hospital of Changchun University of Chinese Medicine, Gongnong Road No.1478, Chaoyang District, Changchun, China Coordinating Investigator (contact email): fuchenwang420@126.com |
Role of sponsor {5c} | The study sponsor and funder had no role in the design, collection, management, analysis, interpretation of data, decision to publish or the preparation of the manuscript, nor in the writing of the report. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Intervention description {11a}
The acupoints electroacupuncture group
Group | Acupoint | Location | Descriptions |
---|---|---|---|
1 | Baihui (GV-20) | At the vertex on the midline, in the depression 5 cun posterior to the anterior hairline and 7 cun superior to the posterior hairline | Punctured horizontally 0.3–0.5 cun |
Shenmen (HT-7) | At the wrist joint, on the radial side of flexor carpi ulnaris, in the depression at the proximal border of the pisiform bone | Punctured perpendicularly 0.5–0.8 cun | |
Sanyinjiao (SP-6) | On the medial side of the lower leg, 3 cun superior to the prominence of the medial malleolus, in a depression close to the medial crest of the tibia | Punctured perpendicularly 1.0–1.5 cun | |
2 | Non-acupoint 1 | On the edge of the tibia 1 to 2 cm lateral to the Zusanli (ST36) horizontally | Punctured perpendicularly 0.5–1 cun |
Non-acupoint 2 | On the half between the tip of the elbow and the axilla | Punctured perpendicularly 0.5–1 cun | |
Non-acupoint 3 | On the ulnar side, half between the epicondylus medialis of the humerus and the ulnar side of the wrist | Punctured perpendicularly 0.5–1 cun |