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Completed

NCT Number: NCT06093750

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

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.

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Key information

Conditions

Preoperative Vegetative Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeine Unfallversicherungsanstalt

Salzburg, 5020, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. 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

    Time frame: HRV-parameters and mean heart rate were obtained in the same time frame as outcome 2.

    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

  2. Age, gender, if they are smokers and if they work in shifts

    Time frame: Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.

    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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Institute for Salutology
  • UKH Salzburg
  • University of Ulm

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.