Stress, EmotionalNCT03192423
Acute Mental Stress During Lumbar Puncture
An observational study of Stress, Emotional and Spinal; Puncture, Complications, Headache, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stress, Emotional, Spinal; Puncture, Complications, Headache, Lumbar Puncture
- How many people
- 50 participants
- Where
- 3 sitesDenmark
- Study dates
- 12 Dec 2016to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 2 recruiting
- Recruiting
Department of Neurology, Rigshospitalet - Glostrup
Glostrup Municipality, Capital Region of Denmark, 2600
Elisabeth Elmo, MD, +4538633044, elisabeth.elmo@regionh.dk
- Recruiting
Department of Neuology, Herlev Hospital
Herlev, Capital Region of Denmark, 2730
Christian T Pinkowsky, MD, +4538684246, christian.tersboel.pinkowsky.01@regionh.dk
- Active, not recruiting
Department of Neurology, University Hospital Zealand
Roskilde, Region Sjælland, 400
About this study
Official title: 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.
Read the 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.
- Keywords
- Stress, Performance of procedures, Lumbar Puncture
- Medical subject headings
- Stress, Psychological, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Appraisal
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
Measured: Five minutes before performance
State Trait Anxiety Inventory - Short (before performance)
A questionaire exploring the stress related anxiety
Measured: Five minutes before performance
State Trait Anxiety Inventory - Short (during performance)
A questionaire exploring the stress related anxiety
Measured: Just before needle insertion
Heart Rate Variability before performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Measured: 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)
Measured: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability before performance (Spectrum analysis)
Heart Rate Variability: LF/HF - ratio
Measured: 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 (%)
Measured: A recording of 5 minutes obtained five minutes before performance.
Heart Rate Variability during performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min)
Measured: 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)
Measured: 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
Measured: 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 (%)
Measured: A recording of 5 minutes obtained five minutes before obtaining liquor or abandoning the procedure.
Secondary outcomes (7)
Patients State Trait Anxiety Inventory - Short
A questionaire exploring the stress related anxiety (scores range from 6-24)
Measured: : Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes
Number of needle insertions,
Measured: Registered during procedure operation
Procedure outcomes
Failing/abandoning the procedure performance (yes/no)
Measured: Registered during procedure operation
Duration of time to needle insertion
A time stamp from first needle penetration of the skin to obtaining the liquor or abandoning the procedure.
Measured: Obtained during procedure, Time from needle penetration of the skin to obtaining liquor (mm:ss)
Confidence in operator
A 10-point anchored Likert scale: 0=not confident - 10=very confident
Measured: Assessed five minutes after termination of the procedure
Pain intensity during procedure
A 10-point anchored Likert scale; 0= no pain - 10= Worst imaginable pain.
Measured: Assessed five minutes after termination of the procedure
Post Dural Puncture Headache
Post Dural Puncture Headache, following the Lübeckers classification
Measured: Telephone interview seven days after the procedure performance date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start12 Dec 2016
- Primary completion1 Jul 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand
- Responsible party
- Principal investigator, Mikael Johannes Vuokko Henriksen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Konge, MD, PhD, Study director, CAMES - Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192423
- Sponsor's protocol ID
- AMSLP
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Mental Stress Among the Physician and Patient During Lumbar Puncture, and Its Impact on Performance and Patient Related Outcomes
- ClinicalTrials.gov ID
- NCT03192423
- Acronym / sponsor ID
- AMSLP
- Keywords
- Stress, Performance of procedures, Lumbar Puncture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Region Zealand
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 1 Jul 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (10 listed)
- 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.
- Performing LP on a regular basis; LP experience of 10-80 procedures.
- No previous lumbar puncture experience
- Lumbar puncture intended on suspicion of Alzheimer or another dementia diagnosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
State Trait Anxiety Inventory - Short (before performance)
Time frame: Five minutes before performance
A questionaire exploring the stress related anxiety
State Trait Anxiety Inventory - Short (during performance)
Time frame: Just before needle insertion
A questionaire exploring the stress related anxiety
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)
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)
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
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 (%)
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)
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)
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
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 (%)
7 secondary outcomes
Patients State Trait Anxiety Inventory - Short
Time frame: : Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes
Time frame: Registered during procedure operation
Procedure outcomes
Time frame: 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)
Confidence in operator
Time frame: Assessed five minutes after termination of the procedure
Pain intensity during procedure
Time frame: Assessed five minutes after termination of the procedure
Post Dural Puncture Headache
Time frame: Telephone interview seven days after the procedure performance date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Konge, MD, PhD study director
CAMES - Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Emotional and Spinal; Puncture, Complications, Headache, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael J Henriksen, MD (+4526275131, mikael.johannes.vuokko.henriksen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Appraisal (time frame: Five minutes before performance). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.