Acute Mental Stress During Lumbar Puncture

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

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.

Study Overview

• Status: Unknown
• Conditions: Stress, Emotional; Lumbar Puncture; Spinal; Puncture, Complications, Headache

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Denmark
  • Capital Region of Denmark
    • Glostrup, Capital Region of Denmark, Denmark, 2600
      • Recruiting
      • Department of Neurology, Rigshospitalet - Glostrup
      • Contact: Elisabeth Elmo, MD; Phone Number: +4538633044; Email: elisabeth.elmo@regionh.dk
    • Herlev, Capital Region of Denmark, Denmark, 2730
      • Recruiting
      • Department of Neuology, Herlev Hospital
      • Contact: Christian T Pinkowsky, MD; Phone Number: +4538684246; Email: christian.tersboel.pinkowsky.01@regionh.dk
  • Region Zealand
    • Roskilde, Region Zealand, Denmark, 400
      • Active, not recruiting
      • Department of Neurology, University Hospital Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Expert; The physicians in the Expert-group will perform a LP following local standard procedure protocol.
Intermediate; The physicians in the Intermediate-group will perform a LP following local standard procedure protocol.
Novice; The physicians in the novice-group will perform a LP following local standard procedure protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Appraisal	Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)	Five minutes before performance
State Trait Anxiety Inventory - Short (before performance)	A questionaire exploring the stress related anxiety	Five minutes before performance
State Trait Anxiety Inventory - Short (during performance)	A questionaire exploring the stress related anxiety	Just before needle insertion
Heart Rate Variability before performance (Heart rate)	Heart Rate Variability: Heart rate (bp/min)	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)	A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance (Spectrum analysis)	Heart Rate Variability: LF/HF - ratio	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 (%)	A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability during performance (Heart rate)	Heart Rate Variability: Heart rate (bp/min)	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)	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	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 (%)	A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients State Trait Anxiety Inventory - Short	A questionaire exploring the stress related anxiety (scores range from 6-24)	: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes	Number of needle insertions,	Registered during procedure operation
Procedure outcomes	Failing/abandoning the procedure performance (yes/no)	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.	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	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.	Assessed five minutes after termination of the procedure
Post Dural Puncture Headache	Post Dural Puncture Headache, following the Lübeckers classification	Telephone interview seven days after the procedure performance date

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Region Zealand
• Investigators: Study Director: Lars Konge, MD, PhD, CAMES - Rigshospitalet

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2016
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (ACTUAL): June 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stress; Lumbar Puncture; Performance of procedures
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pain; Neurologic Manifestations; Wounds and Injuries; Stress, Psychological; Headache
• Other Study ID Numbers: AMSLP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No