Acute Mental Stress During Lumbar Puncture

Stress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03192423
• Other study ID #: AMSLP
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2017
• Last updated: June 19, 2017
• Start date: December 12, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: June 2017
• Source: Rigshospitalet, Denmark
• Contact: Mikael J Henriksen, MD
• Phone: +4526275131
• Email: mikael.johannes.vuokko.henriksen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2017
• Est. primary completion date: July 1, 2017
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Headache
• Lumbar Puncture
• Spinal; Puncture, Complications, Headache
• Stress, Emotional
• Stress, Psychological
• Wounds and Injuries

Locations

Country	Name	City	State
Denmark	Department of Neurology, Rigshospitalet - Glostrup	Glostrup	Capital Region of Denmark
Denmark	Department of Neuology, Herlev Hospital	Herlev	Capital Region of Denmark
Denmark	Department of Neurology, University Hospital Zealand	Roskilde	Region Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	State Trait Anxiety Inventory - Short (before performance)	A questionaire exploring the stress related anxiety	Five minutes before performance
Primary	State Trait Anxiety Inventory - Short (during performance)	A questionaire exploring the stress related anxiety	Just before needle insertion
Primary	Heart Rate Variability before performance (Heart rate)	Heart Rate Variability: Heart rate (bp/min)	A recording of 5 minutes obtained five minutes before performance.
Primary	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.
Primary	Heart Rate Variability before performance (Spectrum analysis)	Heart Rate Variability: LF/HF - ratio	A recording of 5 minutes obtained five minutes before performance.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	Procedure outcomes	Number of needle insertions,	Registered during procedure operation
Secondary	Procedure outcomes	Failing/abandoning the procedure performance (yes/no)	Registered during procedure operation
Secondary	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)
Secondary	Confidence in operator	A 10-point anchored Likert scale: 0=not confident - 10=very confident	Assessed five minutes after termination of the procedure
Secondary	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
Secondary	Post Dural Puncture Headache	Post Dural Puncture Headache, following the Lübeckers classification	Telephone interview seven days after the procedure performance date