Clinical trial NCT03192423: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress, Emotional
Spinal; Puncture, Complications, Headache
Lumbar Puncture
Keywords: Stress
Performance of procedures
Lumbar Puncture
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Region Zealand
First posted: 2017-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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 summary: 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.

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.

Eligibility 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:

* N/A

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.

Primary outcomes:
measure: Cognitive Appraisal
timeFrame: Five minutes before performance
measure: State Trait Anxiety Inventory - Short (before performance)
timeFrame: Five minutes before performance
measure: State Trait Anxiety Inventory - Short (during performance)
timeFrame: Just before needle insertion
measure: Heart Rate Variability before performance (Heart rate)
timeFrame: A recording of 5 minutes obtained five minutes before performance.
measure: Heart Rate Variability before performance (Spectrum analysis)
timeFrame: A recording of 5 minutes obtained five minutes before performance.
measure: Heart Rate Variability before performance (Spectrum analysis)
timeFrame: A recording of 5 minutes obtained five minutes before performance.
measure: Heart Rate Variability before performance (Timedomain analysis)
timeFrame: A recording of 5 minutes obtained five minutes before performance.
measure: Heart Rate Variability during performance (Heart rate)
timeFrame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
measure: Heart Rate Variability during performance (Spectrum analysis)
timeFrame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
measure: Heart Rate Variability during performance (Spectrum analysis)
timeFrame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
measure: Heart Rate Variability during performance (Timedomain analysis)
timeFrame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Secondary outcomes:
measure: Patients State Trait Anxiety Inventory - Short
timeFrame: : Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
measure: Procedure outcomes
timeFrame: Registered during procedure operation
measure: Procedure outcomes
timeFrame: Registered during procedure operation
measure: Duration of time to needle insertion
timeFrame: Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)
measure: Confidence in operator
timeFrame: Assessed five minutes after termination of the procedure
measure: Pain intensity during procedure
timeFrame: Assessed five minutes after termination of the procedure
measure: Post Dural Puncture Headache
timeFrame: Telephone interview seven days after the procedure performance date
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Neurology, Rigshospitalet - Glostrup
state: Capital Region of Denmark
city: Herlev
country: Denmark
facility: Department of Neuology, Herlev Hospital
state: Capital Region of Denmark
city: Roskilde
country: Denmark
facility: Department of Neurology, University Hospital Zealand
state: Region Zealand
Study officials:
affiliation: CAMES - Rigshospitalet
name: Lars Konge, MD, PhD
role: STUDY_DIRECTOR
References: