NCT05530382

Brief Summary

The aim of this study project is to clarify whether defined practical application skills are learned by anesthesiology specialists through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). "Control group" is a traditional instructor-led practical workshop classroom teaching. Hypothesis: A video-based and self-directed learning program shows no difference in the learning successes than traditional face-to-face workshops.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

September 2, 2022

Last Update Submit

May 7, 2024

Conditions

Keywords

Teaching MethodsLearning MethodsSelf-Directed LearningContinuing Medical Education

Outcome Measures

Primary Outcomes (1)

  • Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no)

    Achieved or not achieved based on defined practical assignments and oral questioning using a defined catalogue of questions. The testing is carried out by an expert trained as a key user. The test is rated as successful if 60% or more of the questions are answered successfully. The following four criteria are checked: * Working principle * Security aspect * Handling and operation * Theory-practice transfer Each criterion is assessed with 0-3 points 0 = does not apply 1. = rather does not apply 2. = applies 3. = applies very well The final evaluation of the device test is based on the following granulated scale: A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F \<60% (unsatisfactory)

    10 minutes

Secondary Outcomes (5)

  • level of application skills

    10 minutes

  • open questions after the training

    1 day

  • Time spent

    1 day

  • use of resources

    1 day

  • cost comparison

    1 day

Study Arms (2)

self-guided learning (video and hands-on simulation)

EXPERIMENTAL

video-based self-directed learning

Other: self-guided learning

traditional instructor-led learning

NO INTERVENTION

traditional instructor-led learning in face-to-face workshop

Interventions

video-based self-directed learning for medical device training

self-guided learning (video and hands-on simulation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital
  • written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

Location

Related Publications (2)

  • Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Self-directed learning versus traditional instructor-led learning for education on a new anaesthesia workstation: a noninferiority, randomised, controlled trial. Br J Anaesth. 2025 Oct;135(4):990-996. doi: 10.1016/j.bja.2025.03.043. Epub 2025 May 22.

  • Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation. BMJ Open. 2023 Sep 4;13(9):e070261. doi: 10.1136/bmjopen-2022-070261.

Study Officials

  • Greif Robert, MD, MME, Professor

    University of Berne

    STUDY DIRECTOR
  • Caterina Gutersohn, RN, NA

    University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

October 4, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

All relevant data will be published

Locations