Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- State and Trait Anxiety Inventory (STAI-score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
State and Trait Anxiety Inventory (STAI-score)
时间窗: 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
时间窗: 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
次要结局
- 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.)