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

NCT03163927 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-23

No results posted yet for this study

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

Interventions

OTHER

Simulation-based training

See arm description

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Mikael J Henriksen, MD · CAMES - Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-06-30
Completion
2017-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163927 on ClinicalTrials.gov