- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333354
Effectiveness of Delirium Simulation Education of Nurses in Intensive Care Unit
July 19, 2022 updated by: Yu-Ling Chang, Chang Gung Memorial Hospital
Effectiveness of Delirium Simulation Education on the Self-efficacy and Critical Thinking Skill of Nurses in Intensive Care Unit- Randomized Clinical Trial
Delirium is a common symptom in the intensive care unit, which greatly affects the prognosis of critically ill patients and increases medical costs.
Although many studies have implemented preventive measures, they have not been able to significantly improve the prevalence of delirium, because many medical measures devises in the intensive care unit are still necessary for patients.
Therefore, early detection of patients with delirium symptoms, risk factors, and immediate Delirium management is important.
Nurses are the first line of clinically important roles in assessing delirium symptoms.
So, design a delirium simulation education for nurses is important.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Through literature review, the investigators found that research on delirium in the intensive care unit simulated education interventions are insufficient, and longitudinal studies to explore how long the effect can be maintained or delirium assessment and delirium management are designed dependent on theory are lacking.
Therefore, the purpose of this study was to investigate the effect of delirium simulation education on delirium knowledge, delirium critical thinking, delirium care self-efficacy and satisfaction among nurses in intensive care units, and to explore the influencing factors.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nurses who have worked in the intensive care unit for more than 3 months,
- No physical or mental illness or recent major family events,
- Never received delirium simulation training.
Exclusion Criteria:
- Those who are not working in the intensive care unit for less than 3 months,
- Those who have recently suffered from physical and mental illness or a major family event recently,
- Those who have received delirium simulation training,
- Those who are currently working as nursing supervisors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental(simulation education group)
The experimental group (simulation teaching group), the content of simulation teaching is based on the simulation model, and includes five important elements: Instructor, student, educational practice, simulation situation design and characteristics, and result that design covering the four stages of learning, concrete experience, reflective observation, abstract conceptualization and action experience, and design lesson plans, which include delirium assessment and delirium risk factor detection.
Delirium prevention and management (PADIS guidelines).
The main objectives of the teaching plan design of the experimental group are: to be able to confirm delirium by assessment of the Delirium Assessment Scale; to confirm the risk factors by the history taking; to propose treatment and measures according to the assessment results.
Secondary goals: Be able to perform handovers.
|
The educational course of the experimental group will last for 6 weeks, including classroom teaching and simulated situational teaching.
The classroom teaching will be divided into 3 times, a course of about 2 hours at a time; after the class, simulated situational teaching is also arranged for 4 hours at a time/ Caring for many patients with delirium, and performing related research.
The simulated scenario lesson plan plans to design 3 major themes (delirium assessment, delirium risk factors, delirium prevention, each major theme will have 2 scenarios, each The simulation teaching exercise starts with pre-briefing, and after the end, debriefing reflection and discussion with the students.
|
|
No Intervention: Control(traditional group)
Nurses in the control group did not receive simulated situational teaching, but received classroom teaching 3 times (once every other week) (delirium assessment, risk factor assessment; PADIS treatment), each session of about 2 hours.
In order to avoid inconsistent teaching content, the control group and the experimental group are not to be together in classroom.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness change of delirium care knowledge after simulation teaching
Time Frame: change from baseline in delirium knowledge and 3, 6, 12 months after intervention
|
Effectiveness of participants with simulation teaching as assessed by delirium knowledge questioner, change from baseline in knowledge scores on delirium knowledge questioner at 3,6,12 months
|
change from baseline in delirium knowledge and 3, 6, 12 months after intervention
|
|
Effectiveness change of delirium care self-efficacy after simulation teaching
Time Frame: change from baseline in delirium care self-efficacy and 3, 6, 12 months after intervention
|
Effectiveness of participants with simulation teaching as assessed by delirium care self-efficacy questioner, change from baseline in self-efficacy scores on delirium care self-efficacy questioner at 3,6,12 months
|
change from baseline in delirium care self-efficacy and 3, 6, 12 months after intervention
|
|
Effectiveness change of delirium critical thinking skills after simulation teaching
Time Frame: change from baseline in delirium critical thinking skills and 3, 6, 12 months after intervention
|
Effectiveness of participants with simulation teaching as assessed by delirium critical thinking skills questioner, change from baseline in critical thinking skills scores on delirium critical thinking skills questioner at 3,6,12 months
|
change from baseline in delirium critical thinking skills and 3, 6, 12 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
July 31, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
February 16, 2022
First Submitted That Met QC Criteria
April 9, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST109-2314-B-182-009-MY3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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