Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI

Percutaneous Coronary Intervention Clinical Trial

Official title:

Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789344
• Other study ID #: 301FW
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2018
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Other:
• acupuncture
Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.
• Psychotherapy
Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
• blank control
Blank control subjects would be observed only during this investigation.

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Huan Wang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inflammation mediators level in blood	the blood level of IL-6 and Hs-CRP were detected	1day before, 7days after the intervene
Primary	Change from Baseline Heart Rate Variability at 7 days	The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group	at 1day before and 7 days after percutaneous coronary intervention
Secondary	Scores of HAM-A	scores of HAM-A were recorded on 1day before, 7,14 days after the intervene	1day before, 7,14 days after the intervene
Secondary	Scores of AIS	scores of AIS were recorded on 1day before, 7,14 days	1day before, 7,14 days after the intervene
Secondary	Scores of HRSD	scores of HRSD were recorded on 1day before, 7,14 days	1day before, 7,14 days after the intervene