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

Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Preoperative Vegetative Stress

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Allgemeine Unfallversicherungsanstalt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subjects are recruited after the anesthesia interview with the anesthesiologist.

anesthesiologist. Subjects with elective surgery associated with a low risk of bleeding will be included. This includes procedures such as knee arthroplasties, cruciate ligamentoplasties, or metal removals.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State and Trait Anxiety Inventory (STAI-score)	STAI: State-Trait-Anxiety-Inventory-Score This test consists of 40 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). A score of 20-80 could be achieved, with higher scores correlating with correlated with higher anxiety levels. Accordingly, scores of 20-39, 40-59, and 60-80 would indicate low, moderate, and high anxiety.	First questionnaire is given 40 minutes before transfer to the holding area and the second questionnaire postoperative in the recovery ward directly before transfer back to ward
The measurement method of heart rate variability (especially the parameter of the frequency domain Low Frequency and High Frequency	Low frequency power (LF): Power density spectrum in the frequency range from 0.04-0.15 Hz High frequency power (HF): Power density spectrum in the frequency range from 0.15 to 0.40 Hz	One measurement (3-6 hours), start of measurement together with the first STAI questionnaire (40 min before transfer to the holding area), end of measurement after the second STAI questionnaire is done.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability ("Standard deviation of normal-to-normal (NN) intervals" (SDNN) and "Root Mean Square of successive differences" (RMSSD) of the time domain and "LF/HF-ratio" from the frequency domain) as well as mean heart rate	Standard deviation of NN-intervals (SDNN): intervals in the measuring range; NN-intervals refer to the intervals between normal R-peaks in an electrocardiogram Root Mean Square of successive differences (RMSSD) Low Frequency/High Frequency-ratio (LF/HF ratio): Quotient of the spectrum in LF and the spectrum in HF, No clear assignment, Ratio or Coefficient or Ratio between LF-and HF Band power	HRV-parameters and mean heart rate were obtained in the same time frame as outcome 2.
Age, gender, if they are smokers and if they work in shifts	Age: 18-65 Gender: male, female smoker: no, (never; nonsmoker > 1 year), yes (< 5/d; 6-15/d; >15/d) working in shifts: yes, no	Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
• Collaborators: University of Ulm; UKH Salzburg; Institute for Salutology
• Investigators: Principal Investigator: Gerhard Fritsch, PD. Dr., Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Version 1.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No