Acute Mental Stress During Lumbar Puncture

June 19, 2017 updated by: Mikael Johannes Vuokko Henriksen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Capital Region of Denmark
      • Glostrup, Capital Region of Denmark, Denmark, 2600
        • Recruiting
        • Department of Neurology, Rigshospitalet - Glostrup
        • Contact:
      • Herlev, Capital Region of Denmark, Denmark, 2730
    • Region Zealand
      • Roskilde, Region Zealand, Denmark, 400
        • Active, not recruiting
        • Department of Neurology, University Hospital Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Five minutes before performance
State Trait Anxiety Inventory - Short (before performance)
Time Frame: Five minutes before performance
A questionaire exploring the stress related anxiety
Five minutes before performance
State Trait Anxiety Inventory - Short (during performance)
Time Frame: Just before needle insertion
A questionaire exploring the stress related anxiety
Just before needle insertion
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)
A recording of 5 minutes obtained five minutes before performance.
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)
A recording of 5 minutes obtained five minutes before performance.
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
A recording of 5 minutes obtained five minutes before performance.
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 (%)
A recording of 5 minutes obtained five minutes before performance.
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)
A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
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)
A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
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
A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
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 (%)
A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
: Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes
Time Frame: Registered during procedure operation
Number of needle insertions,
Registered during procedure operation
Procedure outcomes
Time Frame: Registered during procedure operation
Failing/abandoning the procedure performance (yes/no)
Registered during procedure operation
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.
Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)
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
Assessed five minutes after termination of the procedure
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.
Assessed five minutes after termination of the procedure
Post Dural Puncture Headache
Time Frame: Telephone interview seven days after the procedure performance date
Post Dural Puncture Headache, following the Lübeckers classification
Telephone interview seven days after the procedure performance date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Zealand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lars Konge, MD, PhD, CAMES - Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMSLP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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