Nursing EducationNCT05496946
The Efficiency of Two Different Simulation Methods
A study testing Head bathing skill in people with Nursing Education, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, it is emphasized that the use of simulation improves the communication skills of the participants and that teamwork is important in providing patient safety and effective care. It is stated that students experience fear and anxiety in practice due to their lack of knowledge and clinical experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education
- What is being tested?
- Head bathing skill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2021to 30 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a first year student of a nursing undergraduate program,
- To be taking the Nursing Basic Principles and Practices course for the first time,
- Getting a score of at least 80 and above in the Pre-Test for Measuring Head Bath Knowledge Levels, and
- To volunteer to participate in the study.
Who cannot join
- To not volunteer to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University- Faculty of Health Sciences
Istanbul, Kartal
About this study
Official title: The Efficiency of Two Different Simulation Methods on Developing Head Bath Skills in Nursing Students
In the literature, it is emphasized that the use of simulation improves the communication skills of the participants and that teamwork is important in providing patient safety and effective care. It is stated that students experience fear and anxiety in practice due to their lack of knowledge and clinical experience. Continuous repetitions and regular feedback provided by the trainings made by applying simulation increase the performance and self-confidence of the student. It is stated that the possibility of repeated application reduces the anxiety of the students. It is seen that different simulation types are used in the development of skills in nursing students in studies on this subject. As a result; It is seen that simulation has unlimited potential as an educational method and tool in nursing education. However; No study was found on a specific nursing practice and within the simulation scenario. of the study; In this study, it is aimed to evaluate the effectiveness of using standardized/simulated patient and low-fidelity patient models in head bath practice, which is one of the basic skills of nursing students. As a result of this study, the effective training method in the teaching of the head bath skill, which is taught within the scope of the nursing principles course, will be determined. In addition, it is thought that the periodical follow-up of the students (right after the teaching and at the end of the semester) and the permanence level of this education include a different aspect from other studies.
Read the detailed description
There are different definitions in the literature about simulation. Gaba (2004) defines the simulation technique as "reminding or imitating important aspects of the real environment in an interactive way, accompanied by guides, in order to change or improve real experiences". Although there is no single definition of simulation, in general, simulation is a learning method in which a realistic model of an event or process is developed or imitated. Simulation in nursing education is a learning method applied in different ways to minimize the risks that students may encounter in the clinical setting.
There are many different types of simulations that provide knowledge and skills to nursing students, guide about the problems that may be encountered in the clinical environment, and are suitable for real situations. These are divided into low-tech simulation models, standard/simulated patient, computer-assisted simulations, virtual reality and touch systems, and integrated simulations.
The use of simulation in the nursing education curriculum has many advantages. The use of simulation in nursing education; By providing experience-based learning opportunities, it enables students to increase their self-confidence and improve their clinical decision-making skills. Students gain the ability to perform complete care, decision making, assessment, teamwork, skill development and management in a safe environment without misunderstanding the patient's current situation or fear of failure.
The use of simulation in nursing education is gaining importance in Turkey due to the increase in the number of students, insufficient clinical areas and ensuring patient safety.
- Conditions
- Nursing Education
- Being tested
- Head bathing skill
- Keywords
- Nurse-Patient Relations, simulation, standardized patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head bathing skillOther
A group of students will practice the head bathing skill in a model with low proximity to reality, while the students in the other group will practice on a healthy individual (Standardized patient) pretending to be patient.
| Study group | Role | What they receive |
|---|---|---|
| Model with low proximity to reality group | Experimental | The students included in the experimental group 1 practiced the head bathing skill on a model with low proximity to reality. The model used here is a human model belonging to the Gaumard Scientific company with low proximity to reality. Receives: Other: Head bathing skill |
| Standardized patient Group | Experimental | The students in the experimental group 2 practiced the head bath skill on the standardized patient. A standardized patient is a healthy individual pretending to be a patient. Receives: Other: Head bathing skill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized patient
It is expected that the education method based on standard patient practice will be more effective in change the Spielberger State and Trait Anxiety Scale scores related to head washing skills in nursing students.
The Spielberger State and Trait Anxiety Inventory is used to collect data about students' anxiety levels. It consists of a total of 40 items and two parts, namely "State Anxiety Inventory" and "Trait Anxiety Inventory". The State and Trait Anxiety Inventory consists of 40 items. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety.
Measured: 3 months
Model with Low Closeness to Reality
It is expected that the Modified Simulation Effectiveness Tool score will be change for the nursing students who practice the skill on the model, whose closeness to reality is low in the teaching of the head bath skill.
This tool consists of 19 items. The score range of the vehicle is between 18-95. An increase in the score obtained from this tool indicates that the skill performed on the simulation is effective.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start25 Dec 2021
- Primary completion8 Feb 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size of the study; Using the G\* Power 3.1.9.2 program, the mean and standard deviation of a similar study in the literature (İlaslan, 2019) (Spielberger State Anxiety Scale total score mean=28.8; SD=5.4 and Spielberger State Anxiety Scale total score mean=39, 5; SD=10.4). For the calculated effect size=0.91, α=0.05 and power=0.95, it was determined that there should be at least 33 students in both groups, for a total of 66 students. Students in the sample group were randomly assigned by the researcher to the Low-Reality Model (Experimental-1 Group) and Standardized Patient (Experimental-2 Group) groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Furkan Keles, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496946
- Sponsor's protocol ID
- IMU16
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cant RP, Cooper SJ. Simulation-based learning in nurse education: systematic review. J Adv Nurs. 2010 Jan;66(1):3-15. doi: 10.1111/j.1365-2648.2009.05240.x.
PubMed 20423432Alinier G. A typology of educationally focused medical simulation tools. Med Teach. 2007 Oct;29(8):e243-50. doi: 10.1080/01421590701551185.
PubMed 18236268Bradley P. The history of simulation in medical education and possible future directions. Med Educ. 2006 Mar;40(3):254-62. doi: 10.1111/j.1365-2929.2006.02394.x.
PubMed 16483328Klipfel JM, Carolan BJ, Brytowski N, Mitchell CA, Gettman MT, Jacobson TM. Patient safety improvement through in situ simulation interdisciplinary team training. Urol Nurs. 2014 Jan-Feb;34(1):39-46.
PubMed 24716380Leighton K, Ravert P, Mudra V, Macintosh C. Updating the Simulation Effectiveness Tool: Item Modifications and Reevaluation of Psychometric Properties. Nurs Educ Perspect. 2015 Sep-Oct;36(5):317-23. doi: 10.5480/15-1671.
PubMed 26521501Maran NJ, Glavin RJ. Low- to high-fidelity simulation - a continuum of medical education? Med Educ. 2003 Nov;37 Suppl 1:22-8. doi: 10.1046/j.1365-2923.37.s1.9.x.
PubMed 14641635McCaughey CS, Traynor MK. The role of simulation in nurse education. Nurse Educ Today. 2010 Nov;30(8):827-32. doi: 10.1016/j.nedt.2010.03.005. Epub 2010 May 16.
PubMed 20483188Wilford A, Doyle TJ. Integrating simulation training into the nursing curriculum. Br J Nurs. 2006 Sep 28-Oct 11;15(17):926-30. doi: 10.12968/bjon.2006.15.17.21907.
PubMed 17077785Yoo MS, Yoo IY. The effectiveness of standardized patients as a teaching method for nursing fundamentals. J Nurs Educ. 2003 Oct;42(10):444-8. doi: 10.3928/0148-4834-20031001-06.
PubMed 14577730Stefanski RR, Rossler KL. Preparing the novice critical care nurse: a community-wide collaboration using the benefits of simulation. J Contin Educ Nurs. 2009 Oct;40(10):443-51; quiz 452-3. doi: 10.3928/00220124-20090923-03.
PubMed 19831325
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Two Different Simulation Methods on Developing Head Bath Skills in Nursing Students
- ClinicalTrials.gov ID
- NCT05496946
- Acronym / sponsor ID
- IMU16
- Conditions
- Nursing Education
- Keywords
- Nurse-Patient Relations, simulation, standardized patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Aug 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.
In the literature, it is emphasized that the use of simulation improves the communication skills of the participants and that teamwork is important in providing patient safety and effective care. It is stated that students experience fear and anxiety in practice due to their lack of knowledge and clinical experience. Continuous repetitions and regular feedback provided by the trainings made by applying simulation increase the performance and self-confidence of the student. It is stated that the possibility of repeated application reduces the anxiety of the students. It is seen that different simulation types are used in the development of skills in nursing students in studies on this subject. As a result; It is seen that simulation has unlimited potential as an educational method and tool in nursing education. However; No study was found on a specific nursing practice and within the simulation scenario. of the study; In this study, it is aimed to evaluate the effectiveness of using standardized/simulated patient and low-fidelity patient models in head bath practice, which is one of the basic skills of nursing students. As a result of this study, the effective training method in the teaching of the head bath skill, which is taught within the scope of the nursing principles course, will be determined. In addition, it is thought that the periodical follow-up of the students (right after the teaching and at the end of the semester) and the permanence level of this education include a different aspect from other studies.
Detailed description
There are different definitions in the literature about simulation. Gaba (2004) defines the simulation technique as "reminding or imitating important aspects of the real environment in an interactive way, accompanied by guides, in order to change or improve real experiences". Although there is no single definition of simulation, in general, simulation is a learning method in which a realistic model of an event or process is developed or imitated. Simulation in nursing education is a learning method applied in different ways to minimize the risks that students may encounter in the clinical setting.
There are many different types of simulations that provide knowledge and skills to nursing students, guide about the problems that may be encountered in the clinical environment, and are suitable for real situations. These are divided into low-tech simulation models, standard/simulated patient, computer-assisted simulations, virtual reality and touch systems, and integrated simulations.
The use of simulation in the nursing education curriculum has many advantages. The use of simulation in nursing education; By providing experience-based learning opportunities, it enables students to increase their self-confidence and improve their clinical decision-making skills. Students gain the ability to perform complete care, decision making, assessment, teamwork, skill development and management in a safe environment without misunderstanding the patient's current situation or fear of failure.
The use of simulation in nursing education is gaining importance in Turkey due to the increase in the number of students, insufficient clinical areas and ensuring patient safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The sample size of the study; Using the G* Power 3.1.9.2 program, the mean and standard deviation of a similar study in the literature (İlaslan, 2019) (Spielberger State Anxiety Scale total score mean=28.8; SD=5.4 and Spielberger State Anxiety Scale total score mean=39, 5; SD=10.4). For the calculated effect size=0.91, α=0.05 and power=0.95, it was determined that there should be at least 33 students in both groups, for a total of 66 students. Students in the sample group were randomly assigned by the researcher to the Low-Reality Model (Experimental-1 Group) and Standardized Patient (Experimental-2 Group) groups.
| Arm | Type | Receives |
|---|---|---|
| Model with low proximity to reality group | Experimental | Other: Head bathing skillThe students included in the experimental group 1 practiced the head bathing skill on a model with low proximity to reality. The model used here is a human model belonging to the Gaumard Scientific company with low proximity to reality. |
| Standardized patient Group | Experimental | Other: Head bathing skillThe students in the experimental group 2 practiced the head bath skill on the standardized patient. A standardized patient is a healthy individual pretending to be a patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a first year student of a nursing undergraduate program,
- To be taking the Nursing Basic Principles and Practices course for the first time,
- Getting a score of at least 80 and above in the Pre-Test for Measuring Head Bath Knowledge Levels, and
- To volunteer to participate in the study.
Key exclusion criteria (1 listed)
- To not volunteer to participate in the study.
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 |
|---|---|---|
| Head bathing skillA group of students will practice the head bathing skill in a model with low proximity to reality, while the students in the other group will practice on a healthy individual (Standardized patient) pretending to be patient. | Other | Model with low proximity to reality group, Standardized patient Group |
Primary outcome
Standardized patient
Time frame: 3 months
It is expected that the education method based on standard patient practice will be more effective in change the Spielberger State and Trait Anxiety Scale scores related to head washing skills in nursing students. The Spielberger State and Trait Anxiety Inventory is used to collect data about students' anxiety levels. It consists of a total of 40 items and two parts, namely "State Anxiety Inventory" and "Trait Anxiety Inventory". The State and Trait Anxiety Inventory consists of 40 items. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety.
Model with Low Closeness to Reality
Time frame: 3 months
It is expected that the Modified Simulation Effectiveness Tool score will be change for the nursing students who practice the skill on the model, whose closeness to reality is low in the teaching of the head bath skill. This tool consists of 19 items. The score range of the vehicle is between 18-95. An increase in the score obtained from this tool indicates that the skill performed on the simulation is effective.
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 11 Aug 2022.
- Background: PubMed 20423432Cant RP, Cooper SJ. Simulation-based learning in nurse education: systematic review. J Adv Nurs. 2010 Jan;66(1):3-15. doi: 10.1111/j.1365-2648.2009.05240.x.
- Background: PubMed 18236268Alinier G. A typology of educationally focused medical simulation tools. Med Teach. 2007 Oct;29(8):e243-50. doi: 10.1080/01421590701551185.
- Background: PubMed 16483328Bradley P. The history of simulation in medical education and possible future directions. Med Educ. 2006 Mar;40(3):254-62. doi: 10.1111/j.1365-2929.2006.02394.x.
- Background: PubMed 24716380Klipfel JM, Carolan BJ, Brytowski N, Mitchell CA, Gettman MT, Jacobson TM. Patient safety improvement through in situ simulation interdisciplinary team training. Urol Nurs. 2014 Jan-Feb;34(1):39-46.
- Background: PubMed 26521501Leighton K, Ravert P, Mudra V, Macintosh C. Updating the Simulation Effectiveness Tool: Item Modifications and Reevaluation of Psychometric Properties. Nurs Educ Perspect. 2015 Sep-Oct;36(5):317-23. doi: 10.5480/15-1671.
- Background: PubMed 14641635Maran NJ, Glavin RJ. Low- to high-fidelity simulation - a continuum of medical education? Med Educ. 2003 Nov;37 Suppl 1:22-8. doi: 10.1046/j.1365-2923.37.s1.9.x.
- Background: PubMed 20483188McCaughey CS, Traynor MK. The role of simulation in nurse education. Nurse Educ Today. 2010 Nov;30(8):827-32. doi: 10.1016/j.nedt.2010.03.005. Epub 2010 May 16.
- Background: PubMed 17077785Wilford A, Doyle TJ. Integrating simulation training into the nursing curriculum. Br J Nurs. 2006 Sep 28-Oct 11;15(17):926-30. doi: 10.12968/bjon.2006.15.17.21907.
- Background: PubMed 14577730Yoo MS, Yoo IY. The effectiveness of standardized patients as a teaching method for nursing fundamentals. J Nurs Educ. 2003 Oct;42(10):444-8. doi: 10.3928/0148-4834-20031001-06.
- Background: PubMed 19831325Stefanski RR, Rossler KL. Preparing the novice critical care nurse: a community-wide collaboration using the benefits of simulation. J Contin Educ Nurs. 2009 Oct;40(10):443-51; quiz 452-3. doi: 10.3928/00220124-20090923-03.
- Individual participant dataSharing planned: Undecided
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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 Head bathing skill in people with Nursing Education, run by Istanbul Medeniyet 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 4 inclusion and 1 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 11 Aug 2022. 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?
Standardized patient (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05496946, which also lists 10 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 11 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.