<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464018</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/4308</org_study_id>
    <nct_id>NCT04464018</nct_id>
  </id_info>
  <brief_title>Nurse,Intramuscular Injection, Hybrid Simulation</brief_title>
  <official_title>The Effect of Hybrid Simulation in the Development of Intramuscular Injection Skills of Nursing Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was conducted as a randomized controlled experimental study in order to determine&#xD;
      the effect of hybrid simulation training on gaining the intramuscular injection skills of&#xD;
      nursing students. The sample of the study consisted of 126 students (63 study groups, 63&#xD;
      control groups) enrolled in Nursing Principles Course at Pamukkale University Faculty of&#xD;
      Health Sciences in 2018-2019 academic year. In the study, the study group performed hybrid&#xD;
      simulation (standard patient+Digital half hip model simulator) and the control group&#xD;
      performed simulation with low reality simulation method (hip/intramuscular model). Study data&#xD;
      were collected using Student Identification Form, Intramuscular Injection Achievement Test,&#xD;
      Intramuscular Injection Application Skill Assessment Form, Two Column Writing Reflective&#xD;
      Thinking Strategies and Scale of Student Satisfaction and Self-confidence in Learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nursing students need to be proficient in nursing knowledge and skills before entering a&#xD;
      health care environment in order to provide safe care to patients. One of the important and&#xD;
      difficult to accomplish skills that nursing students must learn is the ability to administer&#xD;
      intramuscular injections. In order to avoid complications due to IM injection application, it&#xD;
      is necessary to comply with surgical asepsia, to know the method of application correctly and&#xD;
      to have psychomotor skills. Therefore, nursing students are expected to graduate with&#xD;
      knowledge and skills related to IM injection application during their education. Basic&#xD;
      plastic mannequins without advanced technology, mannequins or models with low technological&#xD;
      features that present the selected anatomical parts of the human body can also be used in&#xD;
      standard patient and hybrid simulation. Hybrid simulation applications contribute to learners&#xD;
      ' ability to develop psychomotor skills in a safe and realistic environment, as well as&#xD;
      problem solving, critical thinking and decision making. Furthermore, hybrid simulations have&#xD;
      become an ethical requirement to improve students ' skills without causing any potential harm&#xD;
      to actual patients. In this study, the effectiveness of HS method will be evaluated to gain&#xD;
      IM injection skills in nursing students. It will be ensured that the students ' knowledge and&#xD;
      skills will be sufficient by increasing their desire to learn about IM injection, where they&#xD;
      experience intense fear and anxiety before going to the clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 8, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized controlled experimental study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intramuscular Injection Achievement Test</measure>
    <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</time_frame>
    <description>This test contains 21 multiple choice questions, including IM injection application topics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intramuscular Injection Application Skill Assessment Form</measure>
    <time_frame>This test was administered 1 time. applied after hybrid simulation</time_frame>
    <description>The IM injection application skill assessment form consists of 39 application steps. the total was calculated over 100 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Two Column Writing Reflective Thinking Strategies</measure>
    <time_frame>This test was administered 1 time. applied after hybrid simulation</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scale of Student Satisfaction and Self-confidence in Learning</measure>
    <time_frame>This test was administered 1 time. applied after hybrid simulation</time_frame>
    <description>It consists of two sub-dimensions,&quot; satisfaction with learning &quot;and&quot; self-confidence&quot;, and a total of 13 items.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Working group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>working grup</intervention_name>
    <description>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.</description>
    <arm_group_label>Working group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students who have not received IM injection skills training before,&#xD;
&#xD;
          -  who have no clinical experience,&#xD;
&#xD;
          -  who have accepted to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who have received IM injection skills training before,&#xD;
&#xD;
          -  who have clinical experience,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>arife şanlıalp zeyrek, pHd</last_name>
    <role>Principal Investigator</role>
    <affiliation>assistant researcher</affiliation>
  </overall_official>
  <overall_official>
    <last_name>nevin kuzu kurban, prof. dr</last_name>
    <role>Study Director</role>
    <affiliation>responsible researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turkey</name>
      <address>
        <city>Denizli</city>
        <state>Pamukkale Universty Hospital</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26852426</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Arife Şanlıalp Zeyrek</investigator_full_name>
    <investigator_title>prelector</investigator_title>
  </responsible_party>
  <keyword>intramuscular injection</keyword>
  <keyword>hybrid simulation</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study results will be announced in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Findings can be shared after the study has been published.</ipd_time_frame>
    <ipd_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_access_criteria>
    <ipd_url>https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464018
org study id: 60116787-020/4308
nct id: NCT04464018
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled experimental study
primary purpose: Other
masking: Single (Participant)
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
description: This test contains 21 multiple choice questions, including IM injection application topics.
measure: Intramuscular Injection Application Skill Assessment Form
time frame: This test was administered 1 time. applied after hybrid simulation
description: The IM injection application skill assessment form consists of 39 application steps. the total was calculated over 100 points.
measure: Two Column Writing Reflective Thinking Strategies
time frame: This test was administered 1 time. applied after hybrid simulation
description: 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.
measure: Scale of Student Satisfaction and Self-confidence in Learning
time frame: This test was administered 1 time. applied after hybrid simulation
description: It consists of two sub-dimensions," satisfaction with learning "and" self-confidence", and a total of 13 items.
arm group label: Working group
arm group type: Experimental
description: 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
arm group label: Control group
arm group type: No Intervention
description: 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
intervention type: Other
intervention name: working grup
description: 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.
arm group label: Working group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: arife şanlıalp zeyrek, pHd
role: Principal Investigator
affiliation: assistant researcher
last name: nevin kuzu kurban, prof. dr
role: Study Director
affiliation: responsible researcher
facility: 
country: Turkey
citation: 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.
PMID: 26852426
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Arife Şanlıalp Zeyrek
investigator title: prelector
sharing ipd: Yes
ipd description: Study results will be announced in a publication
ipd info type: Study Protocol
ipd time frame: Findings can be shared after the study has been published.
ipd 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 url: https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp