Patient SimulationNCT04136691
The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning
A study testing simulation training in people with Patient Simulation and Burns, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This research was conducted as a single-blind randomized control group intervention trial to determine the effectiveness of simulation method performed using high-fidelity human patient simulator in nursing students' burn patient care planning. Read more about this study
- Who is it for?
- Ages 19 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Simulation, Burns
- What is being tested?
- simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2018to 12 Apr 2018
- 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 19 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in the course
- Had not taken this course and any training on burn patient care before
- Accepted to participate in the research
Who cannot join
- Have any records of absence
- Taken this course and training on burn patient care before
- Graduate of health vocational high school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning:a Randomized Controlled Trial
Aim: This research was conducted as a single-blind randomized control group intervention trial to determine the effectiveness of simulation method performed using high-fidelity human patient simulator in nursing students' burn patient care planning.
Read the detailed description
Materials and Methods: The research was carried out with randomly-selected 61 students including 31 in intervention and 30 in control groups who took the Surgical Diseases Nursing Course in the spring term of the 2017-2018 academic year. The research data were collected using "Personal Information Form", "Cognitive Level Assessment Test for Burn Patient Care", "The Student Satisfaction and Self-Confidence in Learning Scale", "Simulation Design Scale", "Educational Practices Questionnaire", and "Evaluation Form for Burn Patient Care Plan". In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed with all students. In the research, the application of burn patient scenario was performed only with the intervention group. Descriptive statistics, Chi-Square, Mann-Whitney U Test, and Wilcoxon Sign Test were used to analyze the data.
- Conditions
- Patient Simulation, Burns
- Being tested
- simulation training
- Keywords
- Simulation, Nursing education, Burns, Nursing process
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation trainingOther
Burn patient scenario was performed with the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| simulation training | Experimental | In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed. In the research, the application of burn patient scenario was performed only with the intervention group. Receives: Other: simulation training |
| Control | No intervention | In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of knowledge scores between groups
First, second and third knowledge tests were applied to measure the level of knowledge.
Measured: The first knowledge test was conducted in the first week, the second knowledge test in the fourth week (1 week after simulation application) and the third knowledge test in the fifth week. Total duration 5 weeks.
Secondary outcomes (1)
Differences of nursing interventions scores between groups
The first and second burn patient care plans were applied to measure the level of care planning.
Measured: The first burn patient care plan was implemented in the second week and the second care plan in the fifth week (2 weeks after simulation application).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start19 Feb 2018
- Primary completion6 Mar 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient SimulationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müjgan ONARICI, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136691
- Sponsor's protocol ID
- Cankırı KU
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: in progress
Publications
Aqel AA, Ahmad MM. High-fidelity simulation effects on CPR knowledge, skills, acquisition, and retention in nursing students. Worldviews Evid Based Nurs. 2014 Dec;11(6):394-400. doi: 10.1111/wvn.12063. Epub 2014 Sep 11.
PubMed 25213578Onarici M, Karadag M. The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning: A Randomized Controlled Trial. J Burn Care Res. 2021 Sep 30;42(5):1011-1016. doi: 10.1093/jbcr/irab018.
PubMed 33517434
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04136691
- Acronym / sponsor ID
- Cankırı KU
- Conditions
- Patient Simulation, Burns
- Keywords
- Simulation, Nursing education, Burns, Nursing process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 23 Oct 2019 (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.
Aim: This research was conducted as a single-blind randomized control group intervention trial to determine the effectiveness of simulation method performed using high-fidelity human patient simulator in nursing students' burn patient care planning.
Detailed description
Materials and Methods: The research was carried out with randomly-selected 61 students including 31 in intervention and 30 in control groups who took the Surgical Diseases Nursing Course in the spring term of the 2017-2018 academic year. The research data were collected using "Personal Information Form", "Cognitive Level Assessment Test for Burn Patient Care", "The Student Satisfaction and Self-Confidence in Learning Scale", "Simulation Design Scale", "Educational Practices Questionnaire", and "Evaluation Form for Burn Patient Care Plan". In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed with all students. In the research, the application of burn patient scenario was performed only with the intervention group. Descriptive statistics, Chi-Square, Mann-Whitney U Test, and Wilcoxon Sign Test were used to analyze the data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulation training | Experimental | Other: simulation trainingIn the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed. In the research, the application of burn patient scenario was performed only with the intervention group. |
| Control | No intervention | –In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed. |
Who may qualify
- Ages
- 19 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in the course
- Had not taken this course and any training on burn patient care before
- Accepted to participate in the research
Key exclusion criteria (3 listed)
- Have any records of absence
- Taken this course and training on burn patient care before
- Graduate of health vocational high school
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 |
|---|---|---|
| simulation trainingBurn patient scenario was performed with the intervention group. | Other | simulation training |
Primary outcome
Differences of knowledge scores between groups
Time frame: The first knowledge test was conducted in the first week, the second knowledge test in the fourth week (1 week after simulation application) and the third knowledge test in the fifth week. Total duration 5 weeks.
First, second and third knowledge tests were applied to measure the level of knowledge.
1 secondary outcome
Differences of nursing interventions scores between groups
Time frame: The first burn patient care plan was implemented in the second week and the second care plan in the fifth week (2 weeks after simulation application).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Background: PubMed 25213578Aqel AA, Ahmad MM. High-fidelity simulation effects on CPR knowledge, skills, acquisition, and retention in nursing students. Worldviews Evid Based Nurs. 2014 Dec;11(6):394-400. doi: 10.1111/wvn.12063. Epub 2014 Sep 11.
- Derived from this study: PubMed 33517434Onarici M, Karadag M. The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning: A Randomized Controlled Trial. J Burn Care Res. 2021 Sep 30;42(5):1011-1016. doi: 10.1093/jbcr/irab018.
- Individual participant dataSharing planned: No. in progress
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation training in people with Patient Simulation and Burns, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences of knowledge scores between groups (time frame: The first knowledge test was conducted in the first week, the second knowledge test in the fourth week (1 week after simulation application) and the third knowledge test in the fifth week. Total duration 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136691, which also lists 2 linked publications.
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 23 Oct 2019.