Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI
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|ClinicalTrials.gov Identifier: NCT03789344|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Coronary Intervention||Other: acupuncture Other: Psychotherapy Other: blank control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||December 30, 2020|
|Experimental: Acupuncture treatment||
Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.
|Active Comparator: Psychotherapy||
Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
|Placebo Comparator: blank control||
Other: blank control
Blank control subjects would be observed only during this investigation.
- Change from Baseline Heart Rate Variability at 7 days [ Time Frame: at 1day before and 7 days after percutaneous coronary intervention ]The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group
- Scores of HAM-A [ Time Frame: 1day before, 7，14 days after the intervene ]scores of HAM-A were recorded on 1day before, 7，14 days after the intervene
- Scores of AIS [ Time Frame: 1day before, 7，14 days after the intervene ]scores of AIS were recorded on 1day before, 7，14 days
- Scores of HRSD [ Time Frame: 1day before, 7，14 days after the intervene ]scores of HRSD were recorded on 1day before, 7，14 days
- inflammation mediators level in blood [ Time Frame: 1day before, 7days after the intervene ]the blood level of IL-6 and Hs-CRP were detected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789344
|PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Huan Wang, M.D. +8610-66876049 email@example.com|
|Principal Investigator: Huan Wang, M.D.|