The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior

January 27, 2019 updated by: Yonsei University
Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.

Study Overview

Study Type

Observational

Enrollment (Actual)

140

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

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20-60 years old male, ASA 1-2, scheduled for elective closed reduction for nasal bone fracture.

Description

Inclusion Criteria:

  1. 20-60 years old male, ASA 1-2
  2. scheduled for elective closed reduction for nasal bone fracture

Exclusion Criteria:

  1. Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
  2. patients with severe cardiopulmonary dysfunction
  3. patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
  4. patients taking any cardiovascular medication
  5. patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
  6. patients refusal

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

Cohorts and Interventions

Group / Cohort
Visual analogue scale (VAS) >5
The degree of surgery-related anxiety assessment using VAS
Visual analogue scale (VAS) ≤5
The degree of surgery-related anxiety assessment using VAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High frequency (HF) of Heart Rate Variability (HRV)
Time Frame: from immediately after tracheal intubation to 5 min after tracheal intubation
High frequency (HF) component of HRV, which represents the parasympathetic activity
from immediately after tracheal intubation to 5 min after tracheal intubation

Collaborators and Investigators

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

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)

September 11, 2014

Primary Completion (Actual)

March 3, 2017

Study Completion (Actual)

March 3, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0599

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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