NCT02011074

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

November 28, 2013

Last Update Submit

November 17, 2014

Conditions

Heart Rate VariabilitySTAISDSGeneral AnesthesiaAnxiety

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    change from baseline in HRV at 10 minutes after induction of general anesthesia

Secondary Outcomes (1)

  • STAI score

    change from baseline in HRV at 10 minutes after induction of general anesthesia

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia

You may qualify if:

  • Hepatocellular carcinoma patients

You may not qualify if:

  • uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kim Myunghee

Gangnamgu, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 13, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)