Spinal Puncture ComplicationsNCT03163927
The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting
A study testing Simulation-based training in people with Spinal Puncture Complications and Simulation-based Training, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
This study will investigate the effect of simulation-based training with mastery learning (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The study will investigate the effect on operators' performance, stress level, and on patient experienced stress, confidence in operator, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Puncture Complications, Simulation-based Training, Stress, Emotional
- What is being tested?
- Simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Feb 2017to Aug 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- MD, or Medical student working as substitute junior medical officer, or having clinical rotation at the study sites.
- Speaking Danish fluently
- Glasgow Coma Scale 15
- Referred to the outpatient clinic for a lumbar puncture.
- Proficiency in the Danish Language
- Age between 18 and 80 years
- Understand study implications and co-operate without a need for personal assistance.
- Providing written and orally informed consent
Who cannot join
- Previous Lumbar Puncture experience
- Previous formal training in the lumbar puncture procedure
- Eligible patients:
- Lumbar puncture intended on suspicion of Alzheimer or other 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
Department of Neurology, Rigshospitalet - Glostrup
Glostrup Municipality, Capital Region of Denmark, 2600
Department of Neuology, Herlev Hospital
Herlev, Capital Region of Denmark, 2730
Department of Neurology, University Hospital Zealand
Roskilde, Region Sjælland, 400
About this study
This study will investigate the effect of simulation-based training with mastery learning (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The study will investigate the effect on operators' performance, stress level, and on patient experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave.
The study will compare the effect of the training to a control group of novices receiving standard training and additionally to an intermediate and an expert group.
The study will provide insight into the translational effect from the simulation based setting to clinical performance. Further, the study will explore: if stress decreases operators' performance; if operators stress affects the patient stress level; and the effect of SBML on patient-related outcomes.
Read the detailed description
The lumbar puncture procedure is considered a complex procedure. Junior doctors hold uncertainties in performing the procedure and perform below stakeholders expectations. This conflicts with the potential need for immediate performance on critical patients.
The traditional training for junior physicians has been guided by the expectation that experience will lead to mastery. This assumption has been disproved by simulation based and observational studies calling for more educational research including its impact on patient outcomes. A contrast to the maxim of "see one, do one, teach one" is mastery learning (ML). ML implies that learners should practice and re-test until they reach a designated mastery level, making the final level the same for all, although the time taken to reach that level may vary.
Novices trained by simulation based training with mastery learning (SBML) achieve a higher performance level than more experienced physicians only having received clinical training. However, the translational effect into the clinical context is unknown as the training and assessment of competence was performed in the simulation based setting, not integrating aspects as patient communication and positioning. For the lumbar puncture, the complexity of the procedure pertains to both technical and non-technical aspects as patient interaction, communication, the corporation with the assistant and environmental conditions.
Hence, there is a need for more knowledge on the effect of simulation-based training with mastery learning for junior doctors' performance in the clinical setting which should include the effect on patient-related outcomes.
As novices describe a fear of doing harm and hold performance related uncertainty, they may be susceptible to experience a stress sensation. Stress during performance of clinical procedures reduces the working memory and is associated with impaired performance. Expert performers' reports that stress during the procedure performance might be transmitted to the patient. Patients experiencing stress during the procedure holds a significantly increased risk of a prolonged duration of post dural puncture headache.
Stress- stimuli, experience, and responses are complex, as the judgment on whether a situation is perceived as pleasant or threatening depends on the individuals' appraisal, which is based: on previous experience; previous learning; the setting and expectations of the outcome. Stress stimuli arise when the appreciation of the situation is negative. Performers holding a strategy for their performance during stress are less prone to experience a stress sensation. Hence, the integration of a strategy for performing the procedure, based on the experts' process goals might benefit novices' risk of experiencing stress during procedure performance. The effect on such stress reduction to the patient experience of stress and the risks of procedure-related side effects has never been investigated.
The aim of this study is to investigate the effect of simulation-based training with mastery learning on novices' lumbar puncture performance, patient related outcomes and stress experienced by the physicians and patients during the procedure. The effect and outcomes will be compared with intermediate and expert lumbar puncture performers.
- Being tested
- Simulation-based training
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based trainingOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive a 1.5-hour standardized simulation-based training course, with mastery learning. Receives: Other: Simulation-based training |
| Control | No intervention | Participants observe a procedure performed by a senior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Performance of the procedure assessed by the Lumbar Puncture Assessment Tool (LumPAT)
Measured: Videos will be recorded at time of lumbar puncture performance, for subsequent ratings within 3 months.
Doctors Heart Rate Variability before performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min);
Measured: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance (Power)
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Measured: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance
Heart Rate Variability: RMSDD (ms)
Measured: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance (pNN50)
Heart Rate Variability: pNN50 (%)
Measured: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (Heart rate)
Heart Rate Variability: Heart rate (bp/min);
Measured: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (Power)
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Measured: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (RMSDD)
Heart Rate Variability: RMSDD (ms)
Measured: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (pNN50)
Heart Rate Variability: pNN50 (%)
Measured: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors 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;
Doctors 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
Secondary outcomes (15)
Patient Heart Rate Variability before performance
Heart Rate Variability: Heart rate (bp/min);
Measured: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Heart Rate Variability: Heart rate (bp/min);
Measured: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Measured: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Measured: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Heart Rate Variability: RMSDD (ms)
Measured: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Heart Rate Variability: RMSDD (ms)
Measured: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Heart Rate Variability: pNN50 (%)
Measured: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Heart Rate Variability: pNN50 (%)
Measured: A 5 minutes recording during procedure handling, just before obtaining liquor.
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, Failing/abandoning the procedure performance (yes/no)
Measured: Registrered during procedure operation
Duration of time to needle insertion
Time from needle penetration of the skin to obtaining liquor (mm:ss)
Measured: Registrered during procedure operation, or evaluated using the videorecordings of the procedure
Confidence in operator
A 10-point Likert scale: 0=not confident - 10=very confident
Measured: Five minutes after termination of the procedure
Pain intensity during procedure
A 10-point Likert scale; 0= no pain - 10= Worst imaginable pain.
Measured: Five minutes after termination of the procedure
Post Dural Puncture Headache
Post Dural Puncture Headache, using the Lübeckers classification
Measured: Telephone interview seven days after the procedure performance date
Days of sickness leave
Days sick leave related to procedure performance
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 posted23 May 2017
- Study start1 Feb 2017
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Puncture ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Mikael Johannes Vuokko Henriksen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mikael J Henriksen, MD, Principal investigator, CAMES - Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163927
- Sponsor's protocol ID
- StressLBP
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 23 May 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 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting
- ClinicalTrials.gov ID
- NCT03163927
- Acronym / sponsor ID
- StressLBP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 23 May 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 will investigate the effect of simulation-based training with mastery learning (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The study will investigate the effect on operators' performance, stress level, and on patient experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave.
The study will compare the effect of the training to a control group of novices receiving standard training and additionally to an intermediate and an expert group.
The study will provide insight into the translational effect from the simulation based setting to clinical performance. Further, the study will explore: if stress decreases operators' performance; if operators stress affects the patient stress level; and the effect of SBML on patient-related outcomes.
Detailed description
The lumbar puncture procedure is considered a complex procedure. Junior doctors hold uncertainties in performing the procedure and perform below stakeholders expectations. This conflicts with the potential need for immediate performance on critical patients.
The traditional training for junior physicians has been guided by the expectation that experience will lead to mastery. This assumption has been disproved by simulation based and observational studies calling for more educational research including its impact on patient outcomes. A contrast to the maxim of "see one, do one, teach one" is mastery learning (ML). ML implies that learners should practice and re-test until they reach a designated mastery level, making the final level the same for all, although the time taken to reach that level may vary.
Novices trained by simulation based training with mastery learning (SBML) achieve a higher performance level than more experienced physicians only having received clinical training. However, the translational effect into the clinical context is unknown as the training and assessment of competence was performed in the simulation based setting, not integrating aspects as patient communication and positioning. For the lumbar puncture, the complexity of the procedure pertains to both technical and non-technical aspects as patient interaction, communication, the corporation with the assistant and environmental conditions.
Hence, there is a need for more knowledge on the effect of simulation-based training with mastery learning for junior doctors' performance in the clinical setting which should include the effect on patient-related outcomes.
As novices describe a fear of doing harm and hold performance related uncertainty, they may be susceptible to experience a stress sensation. Stress during performance of clinical procedures reduces the working memory and is associated with impaired performance. Expert performers' reports that stress during the procedure performance might be transmitted to the patient. Patients experiencing stress during the procedure holds a significantly increased risk of a prolonged duration of post dural puncture headache.
Stress- stimuli, experience, and responses are complex, as the judgment on whether a situation is perceived as pleasant or threatening depends on the individuals' appraisal, which is based: on previous experience; previous learning; the setting and expectations of the outcome. Stress stimuli arise when the appreciation of the situation is negative. Performers holding a strategy for their performance during stress are less prone to experience a stress sensation. Hence, the integration of a strategy for performing the procedure, based on the experts' process goals might benefit novices' risk of experiencing stress during procedure performance. The effect on such stress reduction to the patient experience of stress and the risks of procedure-related side effects has never been investigated.
The aim of this study is to investigate the effect of simulation-based training with mastery learning on novices' lumbar puncture performance, patient related outcomes and stress experienced by the physicians and patients during the procedure. The effect and outcomes will be compared with intermediate and expert lumbar puncture performers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Simulation-based trainingParticipants receive a 1.5-hour standardized simulation-based training course, with mastery learning. |
| Control | No intervention | –Participants observe a procedure performed by a senior. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- MD, or Medical student working as substitute junior medical officer, or having clinical rotation at the study sites.
- Speaking Danish fluently
- Glasgow Coma Scale 15
- Referred to the outpatient clinic for a lumbar puncture.
- Proficiency in the Danish Language
Key exclusion criteria (6 listed)
- Previous Lumbar Puncture experience
- Previous formal training in the lumbar puncture procedure
- Lumbar puncture intended on suspicion of Alzheimer or other dementia diagnosis.
- Cognitive impairment, assessed by the study investigator or local nurse/doctor
- Physical disabilities, requiring personal assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based trainingSee arm description | Other | Intervention |
Primary outcome
Performance
Time frame: Videos will be recorded at time of lumbar puncture performance, for subsequent ratings within 3 months.
Performance of the procedure assessed by the Lumbar Puncture Assessment Tool (LumPAT)
Doctors Heart Rate Variability before performance (Heart rate)
Time frame: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Heart rate (bp/min);
Doctors Heart Rate Variability before performance (Power)
Time frame: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Doctors Heart Rate Variability before performance
Time frame: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: RMSDD (ms)
Doctors Heart Rate Variability before performance (pNN50)
Time frame: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: pNN50 (%)
Doctors Heart Rate Variability during performance (Heart rate)
Time frame: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Heart rate (bp/min);
Doctors Heart Rate Variability during performance (Power)
Time frame: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Doctors Heart Rate Variability during performance (RMSDD)
Time frame: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: RMSDD (ms)
Doctors Heart Rate Variability during performance (pNN50)
Time frame: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: pNN50 (%)
Doctors State Trait Anxiety Inventory - Short
Time frame: Five minutes before performance; Just Before Needle insertion;
A questionaire exploring the stress related anxiety (scores range from 6-24)
Doctors 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)
15 secondary outcomes
Patient Heart Rate Variability before performance
Time frame: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Time frame: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Time frame: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Time frame: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Time frame: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Time frame: A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance
Time frame: A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance
Time frame: A 5 minutes recording during procedure handling, just before obtaining liquor.
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: Registrered during procedure operation
Duration of time to needle insertion
Time frame: Registrered during procedure operation, or evaluated using the videorecordings of the procedure
Confidence in operator
Time frame: Five minutes after termination of the procedure
Pain intensity during procedure
Time frame: Five minutes after termination of the procedure
Post Dural Puncture Headache
Time frame: Telephone interview seven days after the procedure performance date
Days of sickness leave
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 23 May 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.
Mikael J Henriksen, MD principal investigator
CAMES - Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based training in people with Spinal Puncture Complications and Simulation-based Training, 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 8 inclusion and 6 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 23 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: Videos will be recorded at time of lumbar puncture performance, for subsequent ratings within 3 months.). 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 23 May 2017.