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

December 26, 2018 updated by: Huan Wang, MD
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Huan Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Psychotherapy
Other: Psychotherapy
Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
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.
Placebo Comparator: blank control
Other: blank control
Blank control subjects would be observed only during this investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1day before and 7 days after percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
1day before, 7，14 days after the intervene
Scores of HRSD
Time Frame: 1day before, 7，14 days after the intervene
scores of HRSD were recorded on 1day before, 7，14 days
1day before, 7，14 days after the intervene

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation mediators level in blood
Time Frame: 1day before, 7days after the intervene
the blood level of IL-6 and Hs-CRP were detected
1day before, 7days after the intervene

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huan Wang, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 301FW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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