Acute Mental Stress During Lumbar Puncture

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

• Registration Number: NCT03192423
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2016-12-12
• Status Verified: 2017-06
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Primary Completion: 2017-07-01
• Study Completion: 2017-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Appraisal	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)	Five minutes before performance	A questionaire exploring the stress related anxiety
Heart Rate Variability before performance (Spectrum analysis)	A recording of 5 minutes obtained five minutes before performance.	Heart Rate Variability: LF/HF - ratio
Heart Rate Variability before performance (Timedomain analysis)	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)	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)	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)	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)	Just before needle insertion	A questionaire exploring the stress related anxiety
Heart Rate Variability before performance (Heart rate)	A recording of 5 minutes obtained five minutes before performance.	Heart Rate Variability: Heart rate (bp/min)

Secondary Outcome Measures

Name	Time	Method
Patients State Trait Anxiety Inventory - Short	: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure	A questionaire exploring the stress related anxiety (scores range from 6-24)
Procedure outcomes	Registered during procedure operation	Failing/abandoning the procedure performance (yes/no)
Duration of time to needle insertion	Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)	A time stamp from first needle penetration of the skin to obtaining the liquor or abandoning the procedure.
Confidence in operator	Assessed five minutes after termination of the procedure	A 10-point anchored Likert scale: 0=not confident - 10=very confident
Pain intensity during procedure	Assessed five minutes after termination of the procedure	A 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.
Post Dural Puncture Headache	Telephone interview seven days after the procedure performance date	Post Dural Puncture Headache, following the Lübeckers classification

Trial Locations

Locations (3)

Department of Neurology, Rigshospitalet - Glostrup; 🇩🇰 Glostrup, Capital Region of Denmark, Denmark

Department of Neurology, University Hospital Zealand; 🇩🇰 Roskilde, Region Zealand, Denmark

Department of Neuology, Herlev Hospital; 🇩🇰 Herlev, Capital Region of Denmark, Denmark