The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting

NCT03163927 | Unknown

• 1 other identifier: StressLBP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Spinal Puncture Complications; Simulation-based Training; Stress, Emotional

Outcome Measures

Primary Outcomes (11)

• Performance

  Performance of the procedure assessed by the Lumbar Puncture Assessment Tool (LumPAT)

  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);

  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

  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)

  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 (%)

  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);

  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

  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)

  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 (%)

  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)

  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)

  Five minutes before performance

Secondary Outcomes (15)

• Patient Heart Rate Variability before performance

  A recording of 5 minutes obtained five minutes before performance

• Patient Heart Rate Variability during performance

  A 5 minutes recording during procedure handling, just before obtaining liquor.

• Patient Heart Rate Variability before performance

  A recording of 5 minutes obtained five minutes before performance

• Patient Heart Rate Variability during performance

  A 5 minutes recording during procedure handling, just before obtaining liquor.

• Patient Heart Rate Variability before performance

  A recording of 5 minutes obtained five minutes before performance

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive a 1.5-hour standardized simulation-based training course, with mastery learning.

Other: Simulation-based training

Control

NO INTERVENTION

Participants observe a procedure performed by a senior.

Interventions

Simulation-based training OTHER

See arm description

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MD, or Medical student working as substitute junior medical officer, or having clinical rotation at the study sites.
• Speaking Danish fluently

You may not qualify if:

• Previous Lumbar Puncture experience
• Previous formal training in the lumbar puncture procedure
• Eligible patients:
• 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
• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• TrygFonden, Denmark: collaborator

Study Sites (3)

Department of Neurology, Rigshospitalet - Glostrup

Glostrup Municipality, Capital Region of Denmark, 2600, Denmark

Location

Department of Neuology, Herlev Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

Location

Department of Neurology, University Hospital Zealand

Roskilde, Region Sjælland, 400, Denmark

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mikael J Henriksen, MD

  CAMES - Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 23, 2017
• Study Start: February 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)