Clinical trial NCT06093750: Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability
Official title: Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Vegetative Stress
Lead sponsor: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Sponsor class: OTHER_GOV
Collaborators: name: UKH Salzburg
name: University of Ulm
name: Institute for Salutology
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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,
* 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

Primary outcomes:
measure: State and Trait Anxiety Inventory (STAI-score)
timeFrame: 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
measure: The measurement method of heart rate variability (especially the parameter of the frequency domain Low Frequency and High Frequency
timeFrame: 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 outcomes:
measure: 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
timeFrame: HRV-parameters and mean heart rate were obtained in the same time frame as outcome 2.
measure: Age, gender, if they are smokers and if they work in shifts
timeFrame: Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Allgemeine Unfallversicherungsanstalt
Study officials:
affiliation: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
name: Gerhard Fritsch, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References: