Are you healthy and looking to help advance medical science?
You may be eligible to participate in a lumbar puncture clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a lumbar puncture clinical study, and could be compensated for your time.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Lumbar Puncture Clinical Trial in Glostrup Capital Region of Denmark
Are you healthy and looking to help advance medical science?
You may be eligible to participate in a lumbar puncture clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a lumbar puncture clinical study, and could be compensated for your time.
Recruiting
Male & Female
18 - 80
Years old
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.
Details for the study
Population
Physicians: Physicians working at departments with frequent performance of LP. Physicians should represent the three experience levels novices, intermediates and experts. Patients: All patients referred for a lumbar puncture with respect to inclusion and exclusion criteria.
Brief Title
Acute Mental Stress During Lumbar Puncture
Official Title
Acute Mental Stress Among the Physician and Patient During Lumbar Puncture, and Its Impact on Performance and Patient Related Outcomes
Brief Summary
This study explores lumbar puncture operators stress associated with their performance of the<br /> procedure, across three experience levels: Experts, Intermediates, and Novices.<br /><br /> The study will investigate the association of this potential stress to patient experienced<br /> stress and patient related outcomes of the lumbar puncture procedure.
Detailed Description
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Heart Rate Variability during performance (Timedomain analysis)
Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
Primary
Heart Rate Variability during performance (Spectrum analysis)
Heart Rate Variability: LF/HF - ratio
Primary
Heart Rate Variability during performance (Spectrum analysis)
Heart Rate Variability: Total Power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
Primary
State Trait Anxiety Inventory - Short (before performance)
A questionaire exploring the stress related anxiety
Primary
Heart Rate Variability before performance (Timedomain analysis)
Heart Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
Primary
Heart Rate Variability before performance (Spectrum analysis)
Heart Rate Variability: LF/HF - ratio
Primary
Heart Rate Variability before performance (Spectrum analysis)
Heart Rate Variability: Total power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
Primary
Heart Rate Variability before performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Primary
State Trait Anxiety Inventory - Short (during performance)
A questionaire exploring the stress related anxiety
Primary
Cognitive Appraisal
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
Primary
Heart Rate Variability during performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Secondary
Procedure outcomes
Failing/abandoning the procedure performance (yes/no)
Secondary
Patients State Trait Anxiety Inventory - Short
A questionaire exploring the stress related anxiety (scores range from 6-24)
Secondary
Procedure outcomes
Number of needle insertions,
Secondary
Post Dural Puncture Headache
Post Dural Puncture Headache, following the Lübeckers classification
Secondary
Confidence in operator
A 10-point anchored Likert scale: 0=not confident - 10=very confident
Secondary
Pain intensity during procedure
A 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.
Secondary
Duration of time to needle insertion
A time stamp from first needle penetration of the skin to obtaining the liquor or abandoning the procedure.
Study Criteria
Physicians: Inclusion Criteria physicians: - Medical Doctor or Medical student working as substitute junior medical officer - Speaking Danish fluently - Understanding and accepting study implications - For novice group only: Medical student having clinical rotation at the study sites Exclusion Criteria physicians: For expert group physicians: Consultant (or other senior physician position); LP experience > 100 procedures; supervisor for novice performer; Performing LP on a regular basis. For intermediate group physicians: Performing LP on a regular basis; LP experience of 10-80 procedures. For novice group physicians: No previous lumbar puncture experience For patients enrolled in the study: Inclusion Criteria Patients: - Referred to the outpatient clinic for a LP; - Glasgow Coma Scale 15; - Proficiency in the Danish Language; - Age between 18 and 80 years; - Understanding and accepting study implications - Able to co-operate to the procedure without a need for personal assistance; - Providing written and orally informed consent Exclusion Criteria Patients: - Lumbar puncture intended on suspicion of Alzheimer or another dementia diagnosis; - Cognitive impairment, assessed by the study investigator or local nurse/doctor; - - Physical disabilities, requiring personal assistance.