An observational study in Stress, Emotional, Spinal; Puncture, Complications, Headache and Lumbar Puncture, sponsored by Rigshospitalet, Denmark. Status unknown at 3 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
1,227 studies on the registry are indexed under Headache; 203 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 257 observational studies indexed under Headache.
Browse Headache studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Physicians:
Inclusion Criteria physicians:
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:
Exclusion Criteria Patients:
The physicians in the Expert-group will perform a LP following local standard procedure protocol.
The physicians in the Intermediate-group will perform a LP following local standard procedure protocol.
The physicians in the novice-group will perform a LP following local standard procedure protocol.
Cognitive Appraisal
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
Time frame: Five minutes before performance
State Trait Anxiety Inventory - Short (before performance)
A questionaire exploring the stress related anxiety
Time frame: Five minutes before performance
State Trait Anxiety Inventory - Short (during performance)
A questionaire exploring the stress related anxiety
Time frame: Just before needle insertion
Heart Rate Variability before performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Time frame: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance (Spectrum analysis)
Heart Rate Variability: Total power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
Time frame: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance (Spectrum analysis)
Heart Rate Variability: LF/HF - ratio
Time frame: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance (Timedomain analysis)
Heart Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
Time frame: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability during performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Time frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Heart Rate Variability during performance (Spectrum analysis)
Heart Rate Variability: Total Power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
Time frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Heart Rate Variability during performance (Spectrum analysis)
Heart Rate Variability: LF/HF - ratio
Time frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Heart Rate Variability during performance (Timedomain analysis)
Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)
Time frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Patients State Trait Anxiety Inventory - Short
A questionaire exploring the stress related anxiety (scores range from 6-24)
Time frame: : Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes
Number of needle insertions,
Time frame: Registered during procedure operation
Procedure outcomes
Failing/abandoning the procedure performance (yes/no)
Time frame: Registered during procedure operation
Duration of time to needle insertion
A time stamp from first needle penetration of the skin to obtaining the liquor or abandoning the procedure.
Time frame: Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)
Confidence in operator
A 10-point anchored Likert scale: 0=not confident - 10=very confident
Time frame: Assessed five minutes after termination of the procedure
Pain intensity during procedure
A 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.
Time frame: Assessed five minutes after termination of the procedure
Post Dural Puncture Headache
Post Dural Puncture Headache, following the Lübeckers classification
Time frame: Telephone interview seven days after the procedure performance date
Plan to share: No
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Rigshospitalet, Denmark