- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282865
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
Status
Completed
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
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-
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
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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:
- 20-60 years old male, ASA 1-2
- scheduled for elective closed reduction for nasal bone fracture
Exclusion Criteria:
- Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
- patients with severe cardiopulmonary dysfunction
- patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
- patients taking any cardiovascular medication
- patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
- 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 |
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Visual analogue scale (VAS) >5
The degree of surgery-related anxiety assessment using VAS
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Visual analogue scale (VAS) ≤5
The degree of surgery-related anxiety assessment using VAS
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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
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High frequency (HF) component of HRV, which represents the parasympathetic activity
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from immediately after tracheal intubation to 5 min after tracheal intubation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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