NCT03789344

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

December 24, 2018

Last Update Submit

December 26, 2018

Conditions

Percutaneous Coronary Intervention

Keywords

acupuncture, PCI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Scores of HAM-A

    1day before, 7，14 days after the intervene

  • Scores of AIS

    1day before, 7，14 days after the intervene

  • Scores of HRSD

    1day before, 7，14 days after the intervene

Other Outcomes (1)

  • inflammation mediators level in blood

    1day before, 7days after the intervene

Study Arms (3)

Acupuncture treatment

EXPERIMENTAL
Other: acupuncture

Psychotherapy

ACTIVE COMPARATOR
Other: Psychotherapy

blank control

PLACEBO COMPARATOR
Other: blank control

Interventions

acupunctureOTHER

Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.

Acupuncture treatment
PsychotherapyOTHER

Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.

Psychotherapy
blank controlOTHER

Blank control subjects would be observed only during this investigation.

blank control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • Pei JH, Gan F, Bai YH, Xing YL, Jia JJ, Wang H. Instant and short-term effects of acupuncture for depression and anxiety in unstable angina pectoris patients with percutaneous coronary interventions. Front Cardiovasc Med. 2024 Jan 19;11:1173080. doi: 10.3389/fcvm.2024.1173080. eCollection 2024.

    PMID: 38312234DERIVED

MeSH Terms

Interventions

Acupuncture TherapyPsychotherapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 28, 2018

Study Start

December 1, 2018

Primary Completion

May 1, 2019

Study Completion

December 30, 2020

Last Updated

December 28, 2018

Record last verified: 2018-12

Locations

CN(1)