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Acute Mental Stress During Lumbar Puncture

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ClinicalTrials.gov Identifier: NCT03192423
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Stress, Emotional Spinal; Puncture, Complications, Headache Lumbar Puncture

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 Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Mental Stress Among the Physician and Patient During Lumbar Puncture, and Its Impact on Performance and Patient Related Outcomes
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : July 1, 2017
Estimated Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Cognitive Appraisal [ Time Frame: Five minutes before performance ]
    Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)

  2. State Trait Anxiety Inventory - Short (before performance) [ Time Frame: Five minutes before performance ]
    A questionaire exploring the stress related anxiety

  3. State Trait Anxiety Inventory - Short (during performance) [ Time Frame: Just before needle insertion ]
    A questionaire exploring the stress related anxiety

  4. Heart Rate Variability before performance (Heart rate) [ Time Frame: A recording of 5 minutes obtained five minutes before performance. ]
    Heart Rate Variability: Heart rate (bp/min)

  5. Heart Rate Variability before performance (Spectrum analysis) [ Time Frame: 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)

  6. Heart Rate Variability before performance (Spectrum analysis) [ Time Frame: A recording of 5 minutes obtained five minutes before performance. ]
    Heart Rate Variability: LF/HF - ratio

  7. Heart Rate Variability before performance (Timedomain analysis) [ Time Frame: A recording of 5 minutes obtained five minutes before performance. ]
    Heart Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)

  8. Heart Rate Variability during performance (Heart rate) [ Time Frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure. ]
    Heart Rate Variability: Heart rate (bp/min)

  9. Heart Rate Variability during performance (Spectrum analysis) [ Time Frame: 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)

  10. Heart Rate Variability during performance (Spectrum analysis) [ Time Frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure. ]
    Heart Rate Variability: LF/HF - ratio

  11. Heart Rate Variability during performance (Timedomain analysis) [ Time Frame: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure. ]
    Rate Variability before performance Timedomain analysis: RMSDD (ms), pNN50 (%)


Secondary Outcome Measures :
  1. Patients State Trait Anxiety Inventory - Short [ Time Frame: : 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)

  2. Procedure outcomes [ Time Frame: Registered during procedure operation ]
    Number of needle insertions,

  3. Procedure outcomes [ Time Frame: Registered during procedure operation ]
    Failing/abandoning the procedure performance (yes/no)

  4. Duration of time to needle insertion [ Time Frame: 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.

  5. Confidence in operator [ Time Frame: Assessed five minutes after termination of the procedure ]
    A 10-point anchored Likert scale: 0=not confident - 10=very confident

  6. Pain intensity during procedure [ Time Frame: Assessed five minutes after termination of the procedure ]
    A 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.

  7. Post Dural Puncture Headache [ Time Frame: Telephone interview seven days after the procedure performance date ]
    Post Dural Puncture Headache, following the Lübeckers classification


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

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.

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:

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192423


Contacts
Contact: Mikael J Henriksen, MD +4526275131 mikael.johannes.vuokko.henriksen@regionh.dk
Contact: Lars Konge, MD, PhD +4535455404 lars.konge@regionh.dk

Locations
Denmark
Department of Neurology, Rigshospitalet - Glostrup Recruiting
Glostrup, Capital Region of Denmark, Denmark, 2600
Contact: Elisabeth Elmo, MD    +4538633044    elisabeth.elmo@regionh.dk   
Department of Neuology, Herlev Hospital Recruiting
Herlev, Capital Region of Denmark, Denmark, 2730
Contact: Christian T Pinkowsky, MD    +4538684246    christian.tersboel.pinkowsky.01@regionh.dk   
Department of Neurology, University Hospital Zealand Active, not recruiting
Roskilde, Region Zealand, Denmark, 400
Sponsors and Collaborators
Rigshospitalet, Denmark
Region Zealand
Investigators
Study Director: Lars Konge, MD, PhD CAMES - Rigshospitalet
More Information

Responsible Party: Mikael Johannes Vuokko Henriksen, Principal Investigator, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03192423     History of Changes
Other Study ID Numbers: AMSLP
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mikael Johannes Vuokko Henriksen, Rigshospitalet, Denmark:
Stress
Performance of procedures
Lumbar Puncture

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Stress, Psychological
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms