Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability

NCT ID: NCT06093750

Last Updated: 2023-10-23

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-10-02

Brief Summary

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The purpose of the study is to investigate whether there is a correlation between the vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the measurement of heart rate variability (HRV). A subgroup analysis will also be performed to determine whether premedication contributes to a lower STAI score and/or heart rate variability. The primary outcome will be the parameter of frequency-based analysis Low Frequency (LF) and High Frequency (HF), and the STAI score. Secondary outcomes are the parameters Low Frequency/High Frequency-ratio (LF/HF-ratio), Standard deviation of normal-to-normal (NN) intervals (SDNN), Root Mean Square of successive differences" (RMSSD) and mean heart rate, age, gender, if they are smokers and if they work in shifts.

Detailed Description

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Conditions

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Preoperative Vegetative Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects between 18 and 65 years
* Elective surgery with a low risk of bleeding
* American Society of Anesthesiologists (ASA) classification 1-2
* metabolic equivalent of task (MET) \> 4

Exclusion Criteria

* Pre-existing cardiac conditions such as heart failure, arterial hypertension,
* diabetes
* any central nervous system diseases
* cardiac pacemaker
* renal and hepatic insufficiency
* regional or peridural anesthesia
* Pregnancy, lactation
* Drugs that directly influence the autonomic nervous system
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UKH Salzburg

UNKNOWN

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role collaborator

Institute for Salutology

UNKNOWN

Sponsor Role collaborator

Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard Fritsch, PD. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Locations

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Allgemeine Unfallversicherungsanstalt

Salzburg, , Austria

Site Status

Countries

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Austria

Other Identifiers

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Version 1.2

Identifier Type: -

Identifier Source: org_study_id

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