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Clinical Trials/NCT06093750
NCT06093750
Completed
Not Applicable

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

Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA1 site in 1 country50 target enrollmentJune 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoperative Vegetative Stress
Sponsor
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Enrollment
50
Locations
1
Primary Endpoint
State and Trait Anxiety Inventory (STAI-score)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2023
End Date
October 2, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

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,
  • 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

Outcomes

Primary Outcomes

State and Trait Anxiety Inventory (STAI-score)

Time Frame: 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

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.

The measurement method of heart rate variability (especially the parameter of the frequency domain Low Frequency and High Frequency

Time Frame: 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.

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

Secondary Outcomes

  • 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(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(Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.)

Study Sites (1)

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