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NCT02011074 Clinical Trial

Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia

Anxiety Clinical Trial

Official title:
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02011074
Other study ID # 2012-08-043
Secondary ID
Status Completed
Phase N/A
First received November 28, 2013
Last updated November 17, 2014
Start date March 2013
Est. completion date November 2014

Study information
Verified date November 2014
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- Hepatocellular carcinoma patients

Exclusion Criteria:

- uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Kim Myunghee Gangnamgu Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart rate variability change from baseline in HRV at 10 minutes after induction of general anesthesia No
Secondary STAI score change from baseline in HRV at 10 minutes after induction of general anesthesia No
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