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
1 other identifier
observational
50
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2016
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 20, 2017
June 1, 2017
7 months
June 13, 2017
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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 Outcomes (7)
Patients State Trait Anxiety Inventory - Short
: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes
Registered during procedure operation
Procedure outcomes
Registered during procedure operation
Duration of time to needle insertion
Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)
Confidence in operator
Assessed five minutes after termination of the procedure
- +2 more secondary outcomes
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- Lumbar puncture intended on suspicion of Alzheimer or another dementia diagnosis;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Region Zealandcollaborator
Study Sites (3)
Department of Neurology, Rigshospitalet - Glostrup
Glostrup Municipality, Capital Region of Denmark, 2600, Denmark
Department of Neuology, Herlev Hospital
Herlev, Capital Region of Denmark, 2730, Denmark
Department of Neurology, University Hospital Zealand
Roskilde, Region Sjælland, 400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Konge, MD, PhD
CAMES - Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, MD
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 20, 2017
Study Start
December 12, 2016
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share