- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464018
Nurse,Intramuscular Injection, Hybrid Simulation
March 9, 2021 updated by: Arife Şanlıalp Zeyrek, Pamukkale University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pamukkale Universty Hospital
-
Denizli, Pamukkale Universty Hospital, Turkey
- Turkey
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students who have not received IM injection skills training before,
- who have no clinical experience,
- who have accepted to participate in the research
Exclusion Criteria:
- Students who have received IM injection skills training before,
- who have clinical experience,
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Working group
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
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
This test was administered 1 time. applied after hybrid simulation
|
|
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.
|
This test was administered 1 time. applied after hybrid simulation
|
|
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.
|
This test was administered 1 time. applied after hybrid simulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: arife şanlıalp zeyrek, pHd, Assistant researcher
- Study Director: nevin kuzu kurban, prof. dr, responsible researcher
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 17, 2018
Primary Completion (Actual)
September 8, 2018
Study Completion (Actual)
October 15, 2019
Study Registration Dates
First Submitted
July 4, 2020
First Submitted That Met QC Criteria
July 4, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 60116787-020/4308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study results will be announced in a publication
IPD Sharing Time Frame
Findings can be shared after the study has been published.
IPD Sharing Access Criteria
The sociodemographic characteristics of the participants, the test findings including the answers to the research questions and statistical analyzes will be shared.
IPD Sharing Supporting Information Type
- Study Protocol
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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