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/NCT05999305</url>
    </required_header>
    <id_info>
      <org_study_id>N202307017</org_study_id>
      <nct_id>NCT05999305</nct_id>
    </id_info>
    <brief_title>Using an Escape Room Game in Teaching the Critical Care Nursing Course</brief_title>
    <acronym>ER_Game</acronym>
    <official_title>The Effects of Using an Escape Room Game to Improve Senior Nursing Students' Critical Thinking Dispositions and Skills in Vietnam</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Medical 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>
        Critical thinking is one of the most desired outcomes of nursing education worldwide. The&#xD;
        impact of game-based learning, including the use of an escape room game, on the development&#xD;
        of critical thinking ability in nursing students remains uncertain. The main purpose of this&#xD;
        study is going to evaluate an escape room game as a learning method in Critical Care Nursing&#xD;
        course in improving senior nursing students' critical thinking dispositions and skills. In&#xD;
        addition to the main purpose, this study also aims to investigate the effects of&#xD;
        incorporating an escape room game into a Critical Care Nursing course in improving senior&#xD;
        nursing students' knowledge about critical care nursing, learning motivation, and&#xD;
        satisfaction with the learning method. This is a two-arm parallel randomized controlled trial&#xD;
        conducted on senior nursing students at Tra Vinh University in Vietnam. Two teaching methods&#xD;
        in the Critical Care Nursing course will be applied.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Critical thinking is one of the most desired outcomes of nursing education worldwide. The&#xD;
        impact of game-based learning, including the use of an escape room game, on the development&#xD;
        of critical thinking ability in nursing students remains uncertain.&#xD;
  &#xD;
        The main purpose of this study is going to evaluate an escape room game as learning method in&#xD;
        Critical Care Nursing course in improving senior nursing students' critical thinking&#xD;
        dispositions and skills. In addition to the main purpose, this study also aims to investigate&#xD;
        the effects of incorporating an escape room game into a Critical Care Nursing course in&#xD;
        improving senior nursing students' knowledge about critical care nursing, learning&#xD;
        motivation, and satisfaction with the learning method.&#xD;
  &#xD;
        This a two-arm parallel randomized controlled trial conducted on senior nursing students at&#xD;
        Tra Vinh University in Vietnam. Two teaching methods in the Critical Care Nursing course will&#xD;
        be applied. A conventional class with an escape room game will be implemented for the&#xD;
        intervention group while a conventional class with case-based learning will be the teaching&#xD;
        method for the comparison group.&#xD;
  &#xD;
        The study will be a repeated-measurement design with three time points. Mean, standard&#xD;
        deviation, frequency, percentage, t-test, and chi-squared test will be conducted. Generalized&#xD;
        Estimating Equations will be used to analyze the intervention effect and time effect on&#xD;
        scores of critical thinking dispositions and skills, knowledge of critical care nursing, and&#xD;
        learning motivation over three-time points. Generalized Estimating Equations will also allow&#xD;
        us to explore the interaction between group and time, as well as control for any potential&#xD;
        covariates. The intention of this study is that its findings will offer valuable insights for&#xD;
        faculty members to consider incorporating escape room games into their teaching&#xD;
        methodologies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Two teaching methods in the Critical Care Nursing course will be implemented including the conventional teaching combining an escape room game and the conventional class with case-based teaching.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The critical thinking skills of nursing students</measure>
      <time_frame>The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course</time_frame>
      <description>The Critical Thinking Self-Assessment Scale (CTSAS) will be used to assess the critical thinking skills of nursing students. This 46-item scale is scored on a six-point Likert scale of 0 to 6, with 0 corresponding to &quot;never&quot; and 6 to &quot;always.&quot; The total scores range from 0 to 276, with a higher score indicating a higher level in critical thinking skills.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The critical thinking disposition of nursing students</measure>
      <time_frame>The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course</time_frame>
      <description>The Critical Thinking Disposition Scale (CTDS) will measure the critical thinking disposition of nursing students. The CTDS has 11 items with five-point Likert-type responses (1 = strongly disagree; 5 = strongly agree). The total scores range 11-55 for the scale, with 7-35 for the critical openness scale (the first seven items) and 4-20 for reflective skepticism (the last four items). The higher score indicates a better disposition of critical thinking.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The knowledge about Critical Care Nursing of nursing students</measure>
      <time_frame>The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course</time_frame>
      <description>The retention of students' knowledge about Critical Care Nursing will be evaluated through a structured questionnaire. It will consist of thirty multiple-choice questions, covering six topics of the course. Participants will select one answer or &quot;don't know&quot; per question. Each correct response will be scored one points and incorrect response or &quot;don't know&quot; will be scores zero points, resulting in a total score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Student's learning motivation</measure>
      <time_frame>The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course</time_frame>
      <description>The Motivated Strategies for Learning Questionnaire (MSLQ) will be used to assess the students' learning motivation. This 31-item instrument is a 7-point Likert scale, ranging from 1 (not at all true of me) to 7 (very true of me). The total scores range from 31 to 217 with a higher score indicating a higher motivation level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Students' satisfaction with the course.</measure>
      <time_frame>The measurement will be conducted immediately after the completion of the teaching course.</time_frame>
      <description>The 13-item student satisfaction questionnaire was developed to assess students' satisfaction with the teaching method and also their experience with the learning activities throughout the course. This is a 5-point Likert scale (ranging from 1 = strongly disagree to 5 = strongly agree). The total score ranges from 13 to 65, with higher scores indicating a higher level of satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Escape Room Perception of nursing students</measure>
      <time_frame>The measurement will be conducted immediately after the completion of the teaching course.</time_frame>
      <description>The Escape Room Perception Scale (ERPS) will be used to evaluate the perception of nursing students about the escape room game, including its effectiveness in supporting their learning, the nature of the learning activity, and the team learning. The perception scale includes twelve items and is a five-point Likert scale ranging from &quot;1 = strongly disagree&quot; to &quot;5 = strongly agree.&quot; The higher scores that participants achieve, the more satisfied they will feel about a game, and also indicating the effectiveness of the escape room game.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Critical Thinking</condition>
    <arm_group>
      <arm_group_label>The intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The conventional class and an escape room game will be implemented for the intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The comparison group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The conventional class and a case-based learning will be implemented for the comparison</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Teaching the critical care nursing course with an Escape Room game</intervention_name>
      <description>A teacher will begin with a 1.5-hour lecture, followed by an escape room game to reinforce learning through case studies for another 1.5 hours. The first section of the game will be a ten-minute pre-brief. The game will then begin promptly at a designated time and will be played in groups of six to seven students, with each group seated separately in a classroom. The game will last up to fifty minutes, during which all groups will be assisted to complete puzzles within the time limit. After the game, a fifteen-minute debriefing session will be held by the teacher, during which the students will reflect on their performance and what they learned about the cases and related topics. The teacher will finally provide feedback and support to the groups during this session.</description>
      <arm_group_label>The intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Teaching the critical care nursing course with a case-based learning</intervention_name>
      <description>Students in the comparison group will also receive a 1.5 hour lecture which is the same as those in the intervention group. Another 1.5 hour is a case-based learning session, with six sessions in total over six weeks. The case-based learning sessions will include a pre-brief, teamwork, and debrief, and will be facilitated by the same teacher and teaching assistant and will primarily be provided with paper-based case studies.</description>
      <arm_group_label>The comparison group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Nursing students who are in their senior year in the bachelor program and take&#xD;
               Critical Care Nursing which is a required course.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yeu-Hui Chuang, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>School of Nursing, College of Nursing of Taipei Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yeu-Hui Chuang, Doctoral</last_name>
      <phone>02-27361661</phone>
      <phone_ext>6328</phone_ext>
      <email>yeuhui@tmu.edu.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Trung V. Nguyen, Master</last_name>
      <phone>0979273714</phone>
      <phone_ext>+84</phone_ext>
      <email>trungnguyen@tvu.edu.vn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nursing Department of Tra Vinh University</name>
        <address>
          <city>Tra Vinh</city>
          <zip>87110</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <contact>
        <last_name>Hong Thu T. Huynh, Master</last_name>
        <phone>0939069933</phone>
        <phone_ext>+84</phone_ext>
        <email>hongthu2013@tvu.edu.vn</email>
      </contact>
    </location>
    <location_countries>
      <country>Vietnam</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>thinking</keyword>
    <keyword>escape</keyword>
    <keyword>nursing</keyword>
    <keyword>student</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The detailed description of this study and outcomes as well</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/NCT05999305
  org study id: N202307017
  nct id: NCT05999305
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Critical thinking is one of the most desired outcomes of nursing education worldwide. The
        impact of game-based learning, including the use of an escape room game, on the development
        of critical thinking ability in nursing students remains uncertain. The main purpose of this
        study is going to evaluate an escape room game as a learning method in Critical Care Nursing
        course in improving senior nursing students' critical thinking dispositions and skills. In
        addition to the main purpose, this study also aims to investigate the effects of
        incorporating an escape room game into a Critical Care Nursing course in improving senior
        nursing students' knowledge about critical care nursing, learning motivation, and
        satisfaction with the learning method. This is a two-arm parallel randomized controlled trial
        conducted on senior nursing students at Tra Vinh University in Vietnam. Two teaching methods
        in the Critical Care Nursing course will be applied.
  Critical thinking is one of the most desired outcomes of nursing education worldwide. The
        impact of game-based learning, including the use of an escape room game, on the development
        of critical thinking ability in nursing students remains uncertain.
  
        The main purpose of this study is going to evaluate an escape room game as learning method in
        Critical Care Nursing course in improving senior nursing students' critical thinking
        dispositions and skills. In addition to the main purpose, this study also aims to investigate
        the effects of incorporating an escape room game into a Critical Care Nursing course in
        improving senior nursing students' knowledge about critical care nursing, learning
        motivation, and satisfaction with the learning method.
  
        This a two-arm parallel randomized controlled trial conducted on senior nursing students at
        Tra Vinh University in Vietnam. Two teaching methods in the Critical Care Nursing course will
        be applied. A conventional class with an escape room game will be implemented for the
        intervention group while a conventional class with case-based learning will be the teaching
        method for the comparison group.
  
        The study will be a repeated-measurement design with three time points. Mean, standard
        deviation, frequency, percentage, t-test, and chi-squared test will be conducted. Generalized
        Estimating Equations will be used to analyze the intervention effect and time effect on
        scores of critical thinking dispositions and skills, knowledge of critical care nursing, and
        learning motivation over three-time points. Generalized Estimating Equations will also allow
        us to explore the interaction between group and time, as well as control for any potential
        covariates. The intention of this study is that its findings will offer valuable insights for
        faculty members to consider incorporating escape room games into their teaching
        methodologies.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two teaching methods in the Critical Care Nursing course will be implemented including the conventional teaching combining an escape room game and the conventional class with case-based teaching.
  primary purpose: Other
  masking: None (Open Label)
  measure: The critical thinking skills of nursing students
  time frame: The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course
  description: The Critical Thinking Self-Assessment Scale (CTSAS) will be used to assess the critical thinking skills of nursing students. This 46-item scale is scored on a six-point Likert scale of 0 to 6, with 0 corresponding to "never" and 6 to "always." The total scores range from 0 to 276, with a higher score indicating a higher level in critical thinking skills.
  measure: The critical thinking disposition of nursing students
  time frame: The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course
  description: The Critical Thinking Disposition Scale (CTDS) will measure the critical thinking disposition of nursing students. The CTDS has 11 items with five-point Likert-type responses (1 = strongly disagree; 5 = strongly agree). The total scores range 11-55 for the scale, with 7-35 for the critical openness scale (the first seven items) and 4-20 for reflective skepticism (the last four items). The higher score indicates a better disposition of critical thinking.
  measure: The knowledge about Critical Care Nursing of nursing students
  time frame: The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course
  description: The retention of students' knowledge about Critical Care Nursing will be evaluated through a structured questionnaire. It will consist of thirty multiple-choice questions, covering six topics of the course. Participants will select one answer or "don't know" per question. Each correct response will be scored one points and incorrect response or "don't know" will be scores zero points, resulting in a total score
  measure: Student's learning motivation
  time frame: The measurement will be repeated in three time points including the pre-test, immediately after the completion of the teaching course, and one month after the completion of the teaching course
  description: The Motivated Strategies for Learning Questionnaire (MSLQ) will be used to assess the students' learning motivation. This 31-item instrument is a 7-point Likert scale, ranging from 1 (not at all true of me) to 7 (very true of me). The total scores range from 31 to 217 with a higher score indicating a higher motivation level.
  measure: Students' satisfaction with the course.
  time frame: The measurement will be conducted immediately after the completion of the teaching course.
  description: The 13-item student satisfaction questionnaire was developed to assess students' satisfaction with the teaching method and also their experience with the learning activities throughout the course. This is a 5-point Likert scale (ranging from 1 = strongly disagree to 5 = strongly agree). The total score ranges from 13 to 65, with higher scores indicating a higher level of satisfaction.
  measure: The Escape Room Perception of nursing students
  time frame: The measurement will be conducted immediately after the completion of the teaching course.
  description: The Escape Room Perception Scale (ERPS) will be used to evaluate the perception of nursing students about the escape room game, including its effectiveness in supporting their learning, the nature of the learning activity, and the team learning. The perception scale includes twelve items and is a five-point Likert scale ranging from "1 = strongly disagree" to "5 = strongly agree." The higher scores that participants achieve, the more satisfied they will feel about a game, and also indicating the effectiveness of the escape room game.
  arm group label: The intervention group
  arm group type: Experimental
  description: The conventional class and an escape room game will be implemented for the intervention.
  arm group label: The comparison group
  arm group type: Active Comparator
  description: The conventional class and a case-based learning will be implemented for the comparison
  intervention type: Other
  intervention name: Teaching the critical care nursing course with an Escape Room game
  description: A teacher will begin with a 1.5-hour lecture, followed by an escape room game to reinforce learning through case studies for another 1.5 hours. The first section of the game will be a ten-minute pre-brief. The game will then begin promptly at a designated time and will be played in groups of six to seven students, with each group seated separately in a classroom. The game will last up to fifty minutes, during which all groups will be assisted to complete puzzles within the time limit. After the game, a fifteen-minute debriefing session will be held by the teacher, during which the students will reflect on their performance and what they learned about the cases and related topics. The teacher will finally provide feedback and support to the groups during this session.
  arm group label: The intervention group
  intervention type: Other
  intervention name: Teaching the critical care nursing course with a case-based learning
  description: Students in the comparison group will also receive a 1.5 hour lecture which is the same as those in the intervention group. Another 1.5 hour is a case-based learning session, with six sessions in total over six weeks. The case-based learning sessions will include a pre-brief, teamwork, and debrief, and will be facilitated by the same teacher and teaching assistant and will primarily be provided with paper-based case studies.
  arm group label: The comparison group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Yeu-Hui Chuang, Professor
  role: Principal Investigator
  affiliation: School of Nursing, College of Nursing of Taipei Medical University
  last name: Yeu-Hui Chuang, Doctoral
  phone: 02-27361661
  phone ext: 6328
  email: yeuhui@tmu.edu.tw
  last name: Trung V. Nguyen, Master
  phone: 0979273714
  phone ext: +84
  email: trungnguyen@tvu.edu.vn
  facility: 
  contact: 
  country: Vietnam
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: The detailed description of this study and outcomes as well