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

• Sponsor: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA (Other)
• Overall Status: Completed
• CT.gov ID: NCT06093750
• Collaborator: UKH Salzburg (Other), University of Ulm (Other), Institute for Salutology (Other)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preoperative Vegetative Stress

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study
• Actual Study Start Date: Jun 5, 2023
• Actual Primary Completion Date: Sep 30, 2023
• Actual Study Completion Date: Oct 2, 2023

Outcome Measures

Primary Outcome Measures

1. State and Trait Anxiety Inventory (STAI-score) [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 [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 Outcome Measures

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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allgemeine Unfallversicherungsanstalt	Salzburg		Austria	5020

Sponsors and Collaborators

• Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
• UKH Salzburg
• University of Ulm
• Institute for Salutology

Investigators

• Principal Investigator: Gerhard Fritsch, PD. Dr., Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
• ClinicalTrials.gov Identifier: NCT06093750
• Other Study ID Numbers: Version 1.2
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 23, 2023