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

Sponsor
Huan Wang, MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03789344
Collaborator
(none)
240
Enrollment
1
Location
3
Arms
25
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: acupuncture
  • Other: Psychotherapy
  • Other: blank control
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2018
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Heart Rate Variability at 7 days [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 [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 [1day before, 7，14 days after the intervene]

    scores of AIS were recorded on 1day before, 7，14 days

  3. Scores of HRSD [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 [1day before, 7days after the intervene]

    the blood level of IL-6 and Hs-CRP were detected

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PLA General Hospital Beijing Beijing China 100853

Sponsors and Collaborators

  • Huan Wang, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huan Wang, MD, director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT03789344
Other Study ID Numbers:
  • 301FW
First Posted:
Dec 28, 2018
Last Update Posted:
Dec 28, 2018
Last Verified:
Dec 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huan Wang, MD, director, Chinese PLA General Hospital
acupuncture, PCI

Study Results

No Results Posted as of Dec 28, 2018