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Clinical Trials/NCT03192423
NCT03192423
Unknown
Not Applicable

Acute Mental Stress Among the Physician and Patient During Lumbar Puncture, and Its Impact on Performance and Patient Related Outcomes

Rigshospitalet, Denmark3 sites in 1 country50 target enrollmentDecember 12, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Emotional
Sponsor
Rigshospitalet, Denmark
Enrollment
50
Locations
3
Primary Endpoint
Cognitive Appraisal
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2016
End Date
August 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mikael Johannes Vuokko Henriksen

Principal Investigator, MD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cognitive Appraisal

Time Frame: 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)

Time Frame: Five minutes before performance

A questionaire exploring the stress related anxiety

Heart Rate Variability before performance (Spectrum analysis)

Time Frame: A recording of 5 minutes obtained five minutes before performance.

Heart Rate Variability: LF/HF - ratio

Heart Rate Variability before performance (Timedomain analysis)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: Just before needle insertion

A questionaire exploring the stress related anxiety

Heart Rate Variability before performance (Heart rate)

Time Frame: A recording of 5 minutes obtained five minutes before performance.

Heart Rate Variability: Heart rate (bp/min)

Secondary Outcomes

  • 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)

Study Sites (3)

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