Educational ProblemsNCT04464018
Nurse,Intramuscular Injection, Hybrid Simulation
A study testing working grup in people with Educational Problems, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted as a randomized controlled experimental study in order to determine the effect of hybrid simulation training on gaining the intramuscular injection skills of nursing students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- working grup
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2018to 15 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students who have not received IM injection skills training before,
- who have no clinical experience,
- who have accepted to participate in the research
Who cannot join
- Students who have received IM injection skills training before,
- who have clinical experience,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hybrid Simulation in the Development of Intramuscular Injection Skills of Nursing Students
The study was conducted as a randomized controlled experimental study in order to determine the effect of hybrid simulation training on gaining the intramuscular injection skills of nursing students. The sample of the study consisted of 126 students (63 study groups, 63 control groups) enrolled in Nursing Principles Course at Pamukkale University Faculty of Health Sciences in 2018-2019 academic year. In the study, the study group performed hybrid simulation (standard patient+Digital half hip model simulator) and the control group performed simulation with low reality simulation method (hip/intramuscular model). Study data were collected using Student Identification Form, Intramuscular Injection Achievement Test, Intramuscular Injection Application Skill Assessment Form, Two Column Writing Reflective Thinking Strategies and Scale of Student Satisfaction and Self-confidence in Learning.
Read the detailed description
Nursing students need to be proficient in nursing knowledge and skills before entering a health care environment in order to provide safe care to patients. One of the important and difficult to accomplish skills that nursing students must learn is the ability to administer intramuscular injections. In order to avoid complications due to IM injection application, it is necessary to comply with surgical asepsia, to know the method of application correctly and to have psychomotor skills. Therefore, nursing students are expected to graduate with knowledge and skills related to IM injection application during their education. Basic plastic mannequins without advanced technology, mannequins or models with low technological features that present the selected anatomical parts of the human body can also be used in standard patient and hybrid simulation. Hybrid simulation applications contribute to learners ' ability to develop psychomotor skills in a safe and realistic environment, as well as problem solving, critical thinking and decision making. Furthermore, hybrid simulations have become an ethical requirement to improve students ' skills without causing any potential harm to actual patients. In this study, the effectiveness of HS method will be evaluated to gain IM injection skills in nursing students. It will be ensured that the students ' knowledge and skills will be sufficient by increasing their desire to learn about IM injection, where they experience intense fear and anxiety before going to the clinic.
- Conditions
- Educational Problems
- Being tested
- working grup
- Keywords
- intramuscular injection, hybrid simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
working grupOther
After each student received theoretical training, they performed an intravenous injection on the model. In the study group performed hybrid simulation. After finishing the simulation application. the students went to the analysis room and watched their own application videos. The analysis session was held immediately after all the students in the group completed their applications.The IM injection success Test and Student Satisfaction and self-confidence scale were applied to the study and control groups after the laboratory application was completed.
| Study group | Role | What they receive |
|---|---|---|
| Working group | Experimental | Working group (hybrid simulation method) after the theoretical lecture, the application with hybrid simulation method is made by videotaping. Repeat the same practice after 1 Week Receives: Other: working grup |
| Control group | No intervention | Control group (Low reality simulation method) after the theoretical lecture, the application with low reality simulation method is made. Repeat the same practice after 1 Week Control group received only general care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramuscular Injection Achievement Test
This test contains 21 multiple choice questions, including IM injection application topics.
Measured: This test was administered 3 times. before the theoretical subject is explained, after the theoretical subject is explained and after the hybrid simulation is applied
Intramuscular Injection Application Skill Assessment Form
The IM injection application skill assessment form consists of 39 application steps. the total was calculated over 100 points.
Measured: This test was administered 1 time. applied after hybrid simulation
Two Column Writing Reflective Thinking Strategies
In the case of two-column text used in this research, the page is divided horizontally in the middle. Two questions were asked on the left and right side of the page.
Measured: This test was administered 1 time. applied after hybrid simulation
Scale of Student Satisfaction and Self-confidence in Learning
It consists of two sub-dimensions," satisfaction with learning "and" self-confidence", and a total of 13 items.
Measured: This test was administered 1 time. applied after hybrid simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start17 Jan 2018
- Primary completion8 Sep 2018
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies 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
- Model description
- randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arife Şanlıalp Zeyrek, Pamukkale University
- Investigators
- arife şanlıalp zeyrek, pHd, Principal investigator, assistant researchernevin kuzu kurban, prof. dr, Study director, responsible researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464018
- Sponsor's protocol ID
- 60116787-020/4308
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be announced in a publication
Publications
Uys Y, Treadwell I. Using a simulated patient to transfer patient-centred skills from simulated practice to real patients in practice. Curationis. 2014;37(1):e1-e6. doi: 10.4102/curationis.v37i1.1184. Epub 2014 Nov 25.
PubMed 26852426
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrid Simulation in the Development of Intramuscular Injection Skills of Nursing Students
- ClinicalTrials.gov ID
- NCT04464018
- Acronym / sponsor ID
- 60116787-020/4308
- Conditions
- Educational Problems
- Keywords
- intramuscular injection, hybrid simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 9 Jul 2020 (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.
The study was conducted as a randomized controlled experimental study in order to determine the effect of hybrid simulation training on gaining the intramuscular injection skills of nursing students. The sample of the study consisted of 126 students (63 study groups, 63 control groups) enrolled in Nursing Principles Course at Pamukkale University Faculty of Health Sciences in 2018-2019 academic year. In the study, the study group performed hybrid simulation (standard patient+Digital half hip model simulator) and the control group performed simulation with low reality simulation method (hip/intramuscular model). Study data were collected using Student Identification Form, Intramuscular Injection Achievement Test, Intramuscular Injection Application Skill Assessment Form, Two Column Writing Reflective Thinking Strategies and Scale of Student Satisfaction and Self-confidence in Learning.
Detailed description
Nursing students need to be proficient in nursing knowledge and skills before entering a health care environment in order to provide safe care to patients. One of the important and difficult to accomplish skills that nursing students must learn is the ability to administer intramuscular injections. In order to avoid complications due to IM injection application, it is necessary to comply with surgical asepsia, to know the method of application correctly and to have psychomotor skills. Therefore, nursing students are expected to graduate with knowledge and skills related to IM injection application during their education. Basic plastic mannequins without advanced technology, mannequins or models with low technological features that present the selected anatomical parts of the human body can also be used in standard patient and hybrid simulation. Hybrid simulation applications contribute to learners ' ability to develop psychomotor skills in a safe and realistic environment, as well as problem solving, critical thinking and decision making. Furthermore, hybrid simulations have become an ethical requirement to improve students ' skills without causing any potential harm to actual patients. In this study, the effectiveness of HS method will be evaluated to gain IM injection skills in nursing students. It will be ensured that the students ' knowledge and skills will be sufficient by increasing their desire to learn about IM injection, where they experience intense fear and anxiety before going to the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Working group | Experimental | Other: working grupWorking group (hybrid simulation method) after the theoretical lecture, the application with hybrid simulation method is made by videotaping. Repeat the same practice after 1 Week |
| Control group | No intervention | –Control group (Low reality simulation method) after the theoretical lecture, the application with low reality simulation method is made. Repeat the same practice after 1 Week Control group received only general care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students who have not received IM injection skills training before,
- who have no clinical experience,
- who have accepted to participate in the research
Key exclusion criteria (2 listed)
- Students who have received IM injection skills training before,
- who have clinical experience,
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 |
|---|---|---|
| working grupAfter each student received theoretical training, they performed an intravenous injection on the model. In the study group performed hybrid simulation. After finishing the simulation application. the students went to the analysis room and watched their own application videos. The analysis session was held immediately after all the students in the group completed their applications.The IM injection success Test and Student Satisfaction and self-confidence scale were applied to the study and control groups after the laboratory application was completed. | Other | Working group |
Primary outcome
Intramuscular Injection Achievement Test
Time frame: This test was administered 3 times. before the theoretical subject is explained, after the theoretical subject is explained and after the hybrid simulation is applied
This test contains 21 multiple choice questions, including IM injection application topics.
Intramuscular Injection Application Skill Assessment Form
Time frame: This test was administered 1 time. applied after hybrid simulation
The IM injection application skill assessment form consists of 39 application steps. the total was calculated over 100 points.
Two Column Writing Reflective Thinking Strategies
Time frame: This test was administered 1 time. applied after hybrid simulation
In the case of two-column text used in this research, the page is divided horizontally in the middle. Two questions were asked on the left and right side of the page.
Scale of Student Satisfaction and Self-confidence in Learning
Time frame: This test was administered 1 time. applied after hybrid simulation
It consists of two sub-dimensions," satisfaction with learning "and" self-confidence", and a total of 13 items.
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 Mar 2021.
- Background: PubMed 26852426Uys Y, Treadwell I. Using a simulated patient to transfer patient-centred skills from simulated practice to real patients in practice. Curationis. 2014;37(1):e1-e6. doi: 10.4102/curationis.v37i1.1184. Epub 2014 Nov 25.
- Individual participant dataSharing planned: Yes. Study results will be announced in a publication
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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.
arife şanlıalp zeyrek, pHd principal investigator
assistant researcher
nevin kuzu kurban, prof. dr study director
responsible researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing working grup in people with Educational Problems, run by Pamukkale 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 2 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 Mar 2021. 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?
Intramuscular Injection Achievement Test (time frame: This test was administered 3 times. before the theoretical subject is explained, after the theoretical subject is explained and after the hybrid simulation is applied). The study lists 4 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 NCT04464018, which also lists 1 linked publication.
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 Mar 2021.