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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03192423
Enrollment
50
Registered
2017-06-20
Start date
2016-12-12
Completion date
2017-08-01
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Puncture, Spinal; Puncture, Complications, Headache, Stress, Emotional

Keywords

Stress, Performance of procedures, Lumbar Puncture

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.

Interventions

None listed

Sponsors

Region Zealand
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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 insertionA 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)
Heart Rate Variability before performance (Spectrum analysis)A recording of 5 minutes obtained five minutes before performance.Heart Rate Variability: Total power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
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: Total Power (Sum of Low Frequency, Very Low frequency, High Frequency) (ms)
Cognitive AppraisalFive minutes before performanceCognitive 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 performanceA questionaire exploring the stress related anxiety

Secondary

MeasureTime frameDescription
Procedure outcomesRegistered during procedure operationNumber of needle insertions,
Duration of time to needle insertionObtained 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 operatorAssessed five minutes after termination of the procedureA 10-point anchored Likert scale: 0=not confident - 10=very confident
Pain intensity during procedureAssessed five minutes after termination of the procedureA 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.
Post Dural Puncture HeadacheTelephone interview seven days after the procedure performance datePost Dural Puncture Headache, following the Lübeckers classification
Patients State Trait Anxiety Inventory - Short: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedureA questionaire exploring the stress related anxiety (scores range from 6-24)

Countries

Denmark

Contacts

Primary ContactMikael J Henriksen, MD
mikael.johannes.vuokko.henriksen@regionh.dk+4526275131
Backup ContactLars Konge, MD, PhD
lars.konge@regionh.dk+4535455404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026