xml: <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/NCT05963269</url>
    </required_header>
    <id_info>
      <org_study_id>MaltepeU_DemirelN</org_study_id>
      <nct_id>NCT05963269</nct_id>
    </id_info>
    <brief_title>The Effect of the Game on Students' Intramuscular Injection Skills</brief_title>
    <official_title>The Effect of Computer Aided Game on the Development of Intramuscular Injection Application Skills of Nursing Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maltepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maltepe University</source>
    <oversight_info>
      <has_dmc>No</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>
        Today, error rates increase in intramuscular (IM) drug administrations, which are frequently&#xD;
        applied in clinical settings, due to many factors such as the increase in the number of&#xD;
        students in nursing education, the low number of educators, insufficient clinical space and&#xD;
        insufficient laboratory environments. This situation makes it inevitable to use different&#xD;
        teaching methods in nursing education, especially in the acquisition and development of&#xD;
        psychomotor skills. Games, which are a type of virtual simulation methods; It is defined as a&#xD;
        pedagogical tool that offers the student the widest possible learning opportunity,&#xD;
        interesting, interactive media, and a teaching beyond entertainment. It is very important to&#xD;
        acquire the necessary knowledge and skills in the management of intramuscular drug&#xD;
        administration, which will constitute the majority of postgraduate applications of nursing&#xD;
        students, by using today's technologies during their student life. Another factor that is&#xD;
        effective in psychomotor skill learning is; students' anxiety level. Nursing students may&#xD;
        experience anxiety while using the new technique, which negatively affects the learning&#xD;
        process of the student. One of the reasons for the anxiety experienced by the students is&#xD;
        that they have not reached enough professional knowledge and skills. It is observed that this&#xD;
        level of anxiety increases especially in psychomotor skills. In the exams conducted for the&#xD;
        evaluation of laboratory practices in nursing education, the student demonstrates the skills&#xD;
        learned during the term. The level of anxiety he feels during this practice may also affect&#xD;
        his performance. The general result of studies examining the relationship between test&#xD;
        anxiety and academic performance is that there is a negative relationship between test&#xD;
        anxiety and academic success. For this reason, it is very important to control students'&#xD;
        anxiety. Although the level of state anxiety increases from time to time, especially in the&#xD;
        trainings carried out with simulation, it is one of the training methods that increases the&#xD;
        self-confidence of the students by reducing their anxiety in the future. Based on these&#xD;
        reasons, this research; The aim of this study was to evaluate the effect of computer-assisted&#xD;
        game on success and anxiety level in the development of intramuscular injection application&#xD;
        skills in nursing education.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 27, 2022</start_date>
    <completion_date type="Anticipated">September 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2023</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>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Computer-assisted games change students' knowledge about IM injection.</measure>
      <time_frame>2 week</time_frame>
      <description>1 week after playing the game, the level of knowledge will be evaluated by an independent observer with a practice exam.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Video Games</condition>
    <condition>Students</condition>
    <condition>Nursing</condition>
    <condition>Infections</condition>
    <condition>Intramuscular</condition>
    <arm_group>
      <arm_group_label>Students receiving computer game support in intramuscular injection learning</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After learning intramuscular injection with demonstration, a group of students reinforcing intramuscular injection training for 1 week with a computer-assisted game designed by the researcher.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of students learning intramuscular injection only by demonstration</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group of students learning intramuscular injection by demonstration method without computer-assisted games</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Computer assisted intramuscular learning game</intervention_name>
      <description>It is an educational game that can only be opened from the computer, with questions and answers and cases. The game is currently under development by the developers. The researcher will be able to see how many times the students entered the game and how many points they got.</description>
      <arm_group_label>Students receiving computer game support in intramuscular injection learning</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a first year nursing student&#xD;
  &#xD;
            -  To be taking the basics of nursing course for the first time&#xD;
  &#xD;
            -  To have at least 50 points from the IM Injection Information Form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Graduated from Health Vocational High School&#xD;
  &#xD;
            -  Having a communication problem related to vision and hearing&#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>
    <location>
      <facility>
        <name>Maltepe University</name>
        <address>
          <city>Istanbul</city>
          <state>Maltepe</state>
          <zip>34857</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Maltepe University</investigator_affiliation>
      <investigator_full_name>Nehir Demirel</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The collected data will not be shared with any institution or legal person.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963269
  org study id: MaltepeU_DemirelN
  nct id: NCT05963269
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Today, error rates increase in intramuscular (IM) drug administrations, which are frequently
        applied in clinical settings, due to many factors such as the increase in the number of
        students in nursing education, the low number of educators, insufficient clinical space and
        insufficient laboratory environments. This situation makes it inevitable to use different
        teaching methods in nursing education, especially in the acquisition and development of
        psychomotor skills. Games, which are a type of virtual simulation methods; It is defined as a
        pedagogical tool that offers the student the widest possible learning opportunity,
        interesting, interactive media, and a teaching beyond entertainment. It is very important to
        acquire the necessary knowledge and skills in the management of intramuscular drug
        administration, which will constitute the majority of postgraduate applications of nursing
        students, by using today's technologies during their student life. Another factor that is
        effective in psychomotor skill learning is; students' anxiety level. Nursing students may
        experience anxiety while using the new technique, which negatively affects the learning
        process of the student. One of the reasons for the anxiety experienced by the students is
        that they have not reached enough professional knowledge and skills. It is observed that this
        level of anxiety increases especially in psychomotor skills. In the exams conducted for the
        evaluation of laboratory practices in nursing education, the student demonstrates the skills
        learned during the term. The level of anxiety he feels during this practice may also affect
        his performance. The general result of studies examining the relationship between test
        anxiety and academic performance is that there is a negative relationship between test
        anxiety and academic success. For this reason, it is very important to control students'
        anxiety. Although the level of state anxiety increases from time to time, especially in the
        trainings carried out with simulation, it is one of the training methods that increases the
        self-confidence of the students by reducing their anxiety in the future. Based on these
        reasons, this research; The aim of this study was to evaluate the effect of computer-assisted
        game on success and anxiety level in the development of intramuscular injection application
        skills in nursing education.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  measure: Computer-assisted games change students' knowledge about IM injection.
  time frame: 2 week
  description: 1 week after playing the game, the level of knowledge will be evaluated by an independent observer with a practice exam.
  arm group label: Students receiving computer game support in intramuscular injection learning
  arm group type: Active Comparator
  description: After learning intramuscular injection with demonstration, a group of students reinforcing intramuscular injection training for 1 week with a computer-assisted game designed by the researcher.
  arm group label: Group of students learning intramuscular injection only by demonstration
  arm group type: No Intervention
  description: Group of students learning intramuscular injection by demonstration method without computer-assisted games
  intervention type: Other
  intervention name: Computer assisted intramuscular learning game
  description: It is an educational game that can only be opened from the computer, with questions and answers and cases. The game is currently under development by the developers. The researcher will be able to see how many times the students entered the game and how many points they got.
  arm group label: Students receiving computer game support in intramuscular injection learning
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Maltepe University
  investigator full name: Nehir Demirel
  investigator title: Lecturer
  sharing ipd: No
  ipd description: The collected data will not be shared with any institution or legal person.