Acute Mental Stress During Lumbar Puncture

NCT ID: NCT03192423

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2017-08-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Expert

The physicians in the Expert-group will perform a LP following local standard procedure protocol.

No interventions assigned to this group

Intermediate

The physicians in the Intermediate-group will perform a LP following local standard procedure protocol.

No interventions assigned to this group

Novice

The physicians in the novice-group will perform a LP following local standard procedure protocol.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Zealand

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Mikael Johannes Vuokko Henriksen

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Konge, MD, PhD

Role: STUDY_DIRECTOR

CAMES - Rigshospitalet

Locations

Department of Neurology, Rigshospitalet - Glostrup

Glostrup Municipality, Capital Region of Denmark, Denmark

Site Status: RECRUITING

Department of Neuology, Herlev Hospital

Herlev, Capital Region of Denmark, Denmark

Site Status: RECRUITING

Department of Neurology, University Hospital Zealand

Roskilde, Region Sjælland, Denmark

Site Status: ACTIVE_NOT_RECRUITING

Countries

Denmark

Central Contacts

Mikael J Henriksen, MD

Role: CONTACT

mikael.johannes.vuokko.henriksen@regionh.dk

+4526275131

Lars Konge, MD, PhD

Role: CONTACT

lars.konge@regionh.dk

+4535455404

Facility Contacts

Elisabeth Elmo, MD

Role: primary

elisabeth.elmo@regionh.dk

+4538633044

Christian T Pinkowsky, MD

Role: primary

christian.tersboel.pinkowsky.01@regionh.dk

+4538684246

Other Identifiers

AMSLP

Identifier Type: -

Identifier Source: org_study_id