Self EfficacyNCT05333354
Effectiveness of Delirium Simulation Education of Nurses in Intensive Care Unit
A study testing education strategy in people with Self Efficacy and Nursing Caries, run by Chang Gung Memorial Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Nursing Caries, Intensive Care Unit Delirium
- What is being tested?
- education strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Efficacy, Nursing Caries, Intensive Care Unit Delirium, Simulation of Physical Illness
- Being tested
- education strategy
- Keywords
- intensive care unit,nurses,delirium,simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental(simulation education group) | Experimental | 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. Receives: Other: education strategy |
| Control(traditional group) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness change of delirium care knowledge after simulation teaching
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
Measured: change from baseline in delirium knowledge and 3, 6, 12 months after intervention
Effectiveness change of delirium care self-efficacy after simulation teaching
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
Measured: 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
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
Measured: change from baseline in delirium critical thinking skills and 3, 6, 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ling Chang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333354
- Sponsor's protocol ID
- MOST109-2314-B-182-009-MY3
- Status last verified
- Jul 2022
- First submitted
- 16 Feb 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Delirium Simulation Education on the Self-efficacy and Critical Thinking Skill of Nurses in Intensive Care Unit- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05333354
- Acronym / sponsor ID
- MOST109-2314-B-182-009-MY3
- Conditions
- Self Efficacy, Nursing Caries, Intensive Care Unit Delirium, Simulation of Physical Illness
- Keywords
- intensive care unit,nurses,delirium,simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental(simulation education group) | Experimental | Other: education strategyThe 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. |
| Control(traditional group) | No intervention | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education strategyThe 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. | Other | Experimental(simulation education group) |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing education strategy in people with Self Efficacy and Nursing Caries, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness change of delirium care knowledge after simulation teaching (time frame: change from baseline in delirium knowledge and 3, 6, 12 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.