- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063319
Nursing Students' Recognition of and Response to Deteriorating Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Simulation-based nursing education is an increasingly used pedagogical approach.
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.
Specific aims:
- To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
- To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.
Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.
The study is part of a PhD project.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-fidelity simulation
The participants in the intervention group will receive an high-fidelity simulation intervention
|
The set up in the high-fidelity simulation intervention is a deteriorating patient scenario.
|
|
No Intervention: Control
The participants in the control group will not receive any instructional intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
|
Change in total score from 0-20 using 20 multiple choice questions about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures.
Higher scores at post-intervention represent a better outcome.
|
Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levels of self-confidence
Time Frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
|
Change in total responses using 20 questions with five response alternatives (from not at all confident to very confident) about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures .
Higher scores at post-intervention represent a better outcome.
|
Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mariann Fossum, Professor, University of Agder
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 52110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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