Acute Mental Stress Among the Physician and Patient During Lumbar Puncture, and Its Impact on Performance and Patient Related Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Cognitive Appraisal
研究概览
简要总结
This study explores lumbar puncture operators stress associated with their performance of the procedure, across three experience levels: Experts, Intermediates, and Novices.
The study will investigate the association of this potential stress to patient experienced stress and patient related outcomes of the lumbar puncture procedure.
详细描述
The consequences of being in a state of Acute Mental Stress are reduced working memory, decreased psychomotor performance, and impaired performance. Although some levels of increased stress response might be beneficial, there seems to be an upper-limit when performance is reduced.
According to the Cognitive Activation Theory of Stress (CATS), the stress sensation arises when the requirements exceed the resources for a given task. For the LP procedure, a stress sensation among novice residents might arise due to the combination of the LP being a complex procedure depending on both technical as non-technical aspects combined with residents uncertainties for procedural performance and a fear of doing harm.
Despite a growing recognition of stress among residents, the acute mental stress of residents performing invasive procedures has been unacknowledged. Within neurology, internal medicine, and emergency medicine a particular subject for this stress might pertain to residents' first performance of the lumbar puncture.
However, for non-surgical invasive procedures as the LP, there is a lack of evidence for measurements of AMS across experience levels and how this potential stress might influence the performance and patient related outcomes.
Hence, the aim of this study is to explore stress levels across lumbar puncture experience levels and how this potential stress might affect procedural performance and the patients' experience of stress and outcomes of the procedure. Additionally, the study will explore a potential correlation between patient stress and the risk of developing post-dural puncture headache.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cognitive Appraisal
时间窗: Five minutes before performance
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
State Trait Anxiety Inventory - Short (before performance)
时间窗: Five minutes before performance
A questionaire exploring the stress related anxiety
Heart Rate Variability before performance (Spectrum analysis)
时间窗: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability: LF/HF - ratio
Heart Rate Variability before performance (Timedomain analysis)
时间窗: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
Heart Rate Variability during performance (Heart rate)
时间窗: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Heart Rate Variability: Heart rate (bp/min)
Heart Rate Variability during performance (Spectrum analysis)
时间窗: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Heart Rate Variability: LF/HF - ratio
Heart Rate Variability during performance (Timedomain analysis)
时间窗: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
State Trait Anxiety Inventory - Short (during performance)
时间窗: Just before needle insertion
A questionaire exploring the stress related anxiety
Heart Rate Variability before performance (Heart rate)
时间窗: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability: Heart rate (bp/min)
次要结局
- Patients State Trait Anxiety Inventory - Short(: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure)
- Procedure outcomes(Registered during procedure operation)
- Duration of time to needle insertion(Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss))
- Confidence in operator(Assessed five minutes after termination of the procedure)
- Pain intensity during procedure(Assessed five minutes after termination of the procedure)
- Post Dural Puncture Headache(Telephone interview seven days after the procedure performance date)
研究者
Mikael Johannes Vuokko Henriksen
Principal Investigator, MD
Rigshospitalet, Denmark