Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-27 @ 4:14 AM
Study NCT ID:
NCT06093750
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}, {'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.', 'description': 'Low frequency power (LF):\n\nPower density spectrum in the frequency range from 0.04-0.15 Hz\n\nHigh frequency power (HF):\n\nPower density spectrum in the frequency range from 0.15 to 0.40 Hz'}], 'secondaryOutcomes': [{'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.', 'description': 'Standard deviation of NN-intervals (SDNN):\n\nintervals in the measuring range; NN-intervals refer to the intervals between normal R-peaks in an electrocardiogram\n\nRoot Mean Square of successive differences (RMSSD)\n\nLow Frequency/High Frequency-ratio (LF/HF ratio):\n\nQuotient of the spectrum in LF and the spectrum in HF, No clear assignment, Ratio or Coefficient or Ratio between LF-and HF Band power'}, {'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.', 'description': 'Age: 18-65\n\nGender: male, female\n\nsmoker: no, (never; nonsmoker \\> 1 year), yes (\\< 5/d; 6-15/d; \\>15/d)\n\nworking in shifts: yes, no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative Vegetative Stress']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects are recruited after the anesthesia interview with the anesthesiologist.\n\nanesthesiologist. 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between 18 and 65 years\n* Elective surgery with a low risk of bleeding\n* American Society of Anesthesiologists (ASA) classification 1-2\n* metabolic equivalent of task (MET) \\> 4\n\nExclusion Criteria:\n\n* Pre-existing cardiac conditions such as heart failure, arterial hypertension,\n* diabetes\n* any central nervous system diseases\n* cardiac pacemaker\n* renal and hepatic insufficiency\n* regional or peridural anesthesia\n* Pregnancy, lactation\n* Drugs that directly influence the autonomic nervous system'}, 'identificationModule': {'nctId': 'NCT06093750', 'briefTitle': 'Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA'}, 'officialTitle': 'Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study', 'orgStudyIdInfo': {'id': 'Version 1.2'}}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Allgemeine Unfallversicherungsanstalt', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Gerhard Fritsch, PD. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'UKH Salzburg', 'class': 'UNKNOWN'}, {'name': 'University of Ulm', 'class': 'OTHER'}, {'name': 'Institute for Salutology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}