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

NCT ID: NCT02282865

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-11

Study Completion Date

2017-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Closed Reduction Surgery for Nasal Bone Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Visual analogue scale (VAS) >5

The degree of surgery-related anxiety assessment using VAS

No interventions assigned to this group

Visual analogue scale (VAS) ≤5

The degree of surgery-related anxiety assessment using VAS

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0599

Identifier Type: -

Identifier Source: org_study_id

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