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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
Sponsor:
Information provided by (Responsible Party):
Huan Wang, MD, Chinese PLA General Hospital

Brief Summary:
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Other: acupuncture Other: Psychotherapy Other: blank control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Anxiety

Arm Intervention/treatment
Experimental: Acupuncture treatment Other: acupuncture
Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.

Active Comparator: Psychotherapy Other: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Scores of AIS [ Time Frame: 1day before, 7,14 days after the intervene ]
    scores of AIS were recorded on 1day before, 7,14 days

  3. Scores of HRSD [ Time Frame: 1day before, 7,14 days after the intervene ]
    scores of HRSD were recorded on 1day before, 7,14 days


Other Outcome Measures:
  1. inflammation mediators level in blood [ Time Frame: 1day before, 7days after the intervene ]
    the blood level of IL-6 and Hs-CRP were detected



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD).

Exclusion Criteria:

  • The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.

Information from the National Library of Medicine

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


Locations
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China, Beijing
PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Huan Wang, M.D.    +8610-66876049    wanghuan_yy@163.com   
Principal Investigator: Huan Wang, M.D.         
Sponsors and Collaborators
Huan Wang, MD

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Responsible Party: Huan Wang, MD, director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03789344     History of Changes
Other Study ID Numbers: 301FW
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huan Wang, MD, Chinese PLA General Hospital:
acupuncture, PCI