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/NCT06037772</url>
    </required_header>
    <id_info>
      <org_study_id>Bvu_Nursing-2</org_study_id>
      <nct_id>NCT06037772</nct_id>
    </id_info>
    <brief_title>The Effect of Digital Game Use in Teaching Subcutaneous Injection Administration Skills to Nursing Students</brief_title>
    <official_title>The Effect of Using Digital Games on Learning Satisfaction and Self-confidence in Providing Nursing Students With Subcutaneous Injection Skills</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bezmialem Vakif University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bezmialem Vakif 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 goal of this to determine the effect of a digital game-based application on learning&#xD;
        satisfaction and self-confidence in the acquisition of subcutaneous drug administration&#xD;
        skills by nursing students.&#xD;
  &#xD;
        The research hypotheses it aims to answer are:&#xD;
  &#xD;
          -  Hypothesis 1: The subcutaneous injection knowledge level of the students who are&#xD;
             educated with the digital game method is higher than the students who receive the&#xD;
             traditional education.&#xD;
  &#xD;
          -  Hypothesis 2: The subcutaneous injection skill test scores of the students who were&#xD;
             educated with the digital game method were higher than the students who received the&#xD;
             traditional education.&#xD;
  &#xD;
          -  Hypothesis 3: The satisfaction and self-confidence level of the students who are&#xD;
             educated with the digital game method towards subcutaneous injection is higher than the&#xD;
             students who receive the traditional education.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In studies on the use of digital games in nursing education; Students value instant feedback,&#xD;
        visuals and experiential learning, the game developed to improve their decision-making and&#xD;
        reasoning skills is extremely useful, useful and enjoyable, from nursing students to those&#xD;
        with no previous operating room experience. It has been stated that when the application is&#xD;
        made with a game-like simulation, the information is more permanent, they behave more&#xD;
        collaboratively, and they experience less fear. The study was planned in a randomized&#xD;
        controlled experimental design with pretest-posttest, experimental and control groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 27, 2023</start_date>
    <completion_date type="Actual">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 25, 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>
      <intervention_model_description>pretest-posttest, randomized controlled experimental design with experimental and control groups</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Informed consent form was obtained from the participants</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Digital game method and subcutaneous injection knowledge level-pre-test</measure>
      <time_frame>&quot;1 week&quot;</time_frame>
      <description>The level of knowledge about subcutaneous injection was measured by the &quot;Subcutaneous Injection Knowledge Test&quot;, which was prepared by the researchers in line with the literature and submitted to expert opinion and whose Content Validity was calculated. The subcutaneous injection knowledge test is a multiple choice test consisting of 25 questions. The scores obtained from the test will not be classified according to the level of achievement, the averages of the achievement scores of the groups were compared.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Digital game and subcutaneous injection skill level</measure>
      <time_frame>&quot;2 week&quot;</time_frame>
      <description>Subcutaneous injection skill level was measured with the &quot;Subcutaneous Heparin Injection Administration Skill Checklist&quot;, which was prepared by the researchers in line with the literature and submitted to expert opinion and whose Content Validity was calculated. There are 33 items in the Subcutaneous Heparin Injection Administration Skill Checklist. Each item consists of three points as &quot;adequate&quot;, &quot;developmental&quot; and &quot;inadequate&quot;, respectively. The scores of these degrees are &quot;2&quot;, &quot;1&quot;, &quot;0&quot;, respectively. The highest score that can be obtained from the test is &quot;66&quot; and the lowest score is &quot;0&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of satisfaction and self-confidence in digital gaming and learning</measure>
      <time_frame>&quot;2 week&quot;</time_frame>
      <description>Students' satisfaction and self-confidence levels were measured with the Turkish validity and reliability study &quot;Learning Satisfaction and Confidence in Learning Scale&quot;. The scale consists of &quot;13&quot; items and the 13th item of the scale is reverse coded. Each item was scored on a five-point Likert scale between &quot;strongly disagree-strongly agree&quot;. The lowest score that can be obtained from the scale is 13, and the highest score is 65.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Digital game method and subcutaneous injection knowledge level-post-test</measure>
      <time_frame>&quot;4 week&quot;</time_frame>
      <description>The level of knowledge about subcutaneous injection was measured by the &quot;Subcutaneous Injection Knowledge Test&quot;, which was prepared by the researchers in accordance with the literature and presented to the expert opinion and whose Content Validity was calculated. The subcutaneous injection knowledge test is a multiple choice test consisting of 25 questions. The post-test was administered to both groups 2 weeks after all the interventions. The scores obtained from the test will not be classified according to the level of success, the averages of the groups' achievement scores will be compared.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">68</enrollment>
    <condition>Nursing Education</condition>
    <arm_group>
      <arm_group_label>Subcutaneous injection practice game</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the subcutaneous injection was explained to the experimental group, the digital game developed for subcutaneous injection was explained and they were allowed to play the game for a week. Afterwards, the experimental group was shown the subcutaneous injection application on a low-reality model of the abdomen, and the students were allowed to practice the skill.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The students in the control group were given the traditional education method (subcutaneous injection application on a low-reality abdominal model after the completion of the theoretical course on the subject of subcutaneous injection).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>subcutaneous injection administration game</intervention_name>
      <description>The subcutaneous injection practice game was developed to examine nursing students' injection practice skills and its effect on their satisfaction with learning.</description>
      <arm_group_label>Subcutaneous injection practice game</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control group</intervention_name>
      <description>only</description>
      <arm_group_label>Subcutaneous injection practice game</arm_group_label>
      <arm_group_label>Traditional education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering to participate in the research&#xD;
  &#xD;
            -  Being a 1st year nursing student&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous training in subcutaneous application skills&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hatice Kaya, Professor</last_name>
      <role>Study Director</role>
      <affiliation>İstanbul University-Cerrahpasa</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Burcu Demircan</name>
        <address>
          <city>Istanbul</city>
          <zip>34093</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
      <investigator_full_name>Burcu Demircan</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>learning satisfaction</keyword>
    <keyword>self-confidence</keyword>
    <keyword>digital game</keyword>
    <keyword>nursing students</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Since the study phases have not yet been completed and the thesis process is ongoing, the data is not suitable for sharing.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 1, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT06037772/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06037772
  org study id: Bvu_Nursing-2
  nct id: NCT06037772
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this to determine the effect of a digital game-based application on learning
        satisfaction and self-confidence in the acquisition of subcutaneous drug administration
        skills by nursing students.
  
        The research hypotheses it aims to answer are:
  
          -  Hypothesis 1: The subcutaneous injection knowledge level of the students who are
             educated with the digital game method is higher than the students who receive the
             traditional education.
  
          -  Hypothesis 2: The subcutaneous injection skill test scores of the students who were
             educated with the digital game method were higher than the students who received the
             traditional education.
  
          -  Hypothesis 3: The satisfaction and self-confidence level of the students who are
             educated with the digital game method towards subcutaneous injection is higher than the
             students who receive the traditional education.
  In studies on the use of digital games in nursing education; Students value instant feedback,
        visuals and experiential learning, the game developed to improve their decision-making and
        reasoning skills is extremely useful, useful and enjoyable, from nursing students to those
        with no previous operating room experience. It has been stated that when the application is
        made with a game-like simulation, the information is more permanent, they behave more
        collaboratively, and they experience less fear. The study was planned in a randomized
        controlled experimental design with pretest-posttest, experimental and control groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: pretest-posttest, randomized controlled experimental design with experimental and control groups
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  masking description: Informed consent form was obtained from the participants
  measure: Digital game method and subcutaneous injection knowledge level-pre-test
  time frame: "1 week"
  description: The level of knowledge about subcutaneous injection was measured by the "Subcutaneous Injection Knowledge Test", which was prepared by the researchers in line with the literature and submitted to expert opinion and whose Content Validity was calculated. The subcutaneous injection knowledge test is a multiple choice test consisting of 25 questions. The scores obtained from the test will not be classified according to the level of achievement, the averages of the achievement scores of the groups were compared.
  measure: Digital game and subcutaneous injection skill level
  time frame: "2 week"
  description: Subcutaneous injection skill level was measured with the "Subcutaneous Heparin Injection Administration Skill Checklist", which was prepared by the researchers in line with the literature and submitted to expert opinion and whose Content Validity was calculated. There are 33 items in the Subcutaneous Heparin Injection Administration Skill Checklist. Each item consists of three points as "adequate", "developmental" and "inadequate", respectively. The scores of these degrees are "2", "1", "0", respectively. The highest score that can be obtained from the test is "66" and the lowest score is "0".
  measure: Level of satisfaction and self-confidence in digital gaming and learning
  time frame: "2 week"
  description: Students' satisfaction and self-confidence levels were measured with the Turkish validity and reliability study "Learning Satisfaction and Confidence in Learning Scale". The scale consists of "13" items and the 13th item of the scale is reverse coded. Each item was scored on a five-point Likert scale between "strongly disagree-strongly agree". The lowest score that can be obtained from the scale is 13, and the highest score is 65.
  measure: Digital game method and subcutaneous injection knowledge level-post-test
  time frame: "4 week"
  description: The level of knowledge about subcutaneous injection was measured by the "Subcutaneous Injection Knowledge Test", which was prepared by the researchers in accordance with the literature and presented to the expert opinion and whose Content Validity was calculated. The subcutaneous injection knowledge test is a multiple choice test consisting of 25 questions. The post-test was administered to both groups 2 weeks after all the interventions. The scores obtained from the test will not be classified according to the level of success, the averages of the groups' achievement scores will be compared.
  arm group label: Subcutaneous injection practice game
  arm group type: Experimental
  description: After the subcutaneous injection was explained to the experimental group, the digital game developed for subcutaneous injection was explained and they were allowed to play the game for a week. Afterwards, the experimental group was shown the subcutaneous injection application on a low-reality model of the abdomen, and the students were allowed to practice the skill.
  arm group label: Traditional education
  arm group type: Active Comparator
  description: The students in the control group were given the traditional education method (subcutaneous injection application on a low-reality abdominal model after the completion of the theoretical course on the subject of subcutaneous injection).
  intervention type: Other
  intervention name: subcutaneous injection administration game
  description: The subcutaneous injection practice game was developed to examine nursing students' injection practice skills and its effect on their satisfaction with learning.
  arm group label: Subcutaneous injection practice game
  intervention type: Other
  intervention name: control group
  description: only
  arm group label: Subcutaneous injection practice game
  arm group label: Traditional education
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hatice Kaya, Professor
  role: Study Director
  affiliation: İstanbul University-Cerrahpasa
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bezmialem Vakif University
  investigator full name: Burcu Demircan
  investigator title: Lecturer
  sharing ipd: No
  ipd description: Since the study phases have not yet been completed and the thesis process is ongoing, the data is not suitable for sharing.
  provided document: 