<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20160102025809N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of a pediatric airway management training program delivered through two methods of a role-playing simulation and an escape room-based serious game on knowledge and performance of students at Guilan University of Medical Sciences by using an interdisciplinary teaching approach: A randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of a pediatric airway management training program delivered through two methods of a role-playing simulation and an escape room-based serious game on knowledge and performance of students at Guilan University of Medical Sciences by using an interdisciplinary teaching approach: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: All selected students will be classified using stratified block randomization with block sizes of three and evenly (in a 1:1:1 ratio) divided into three groups: intervention group one (role-playing with simulation; number=30), intervention group two (serious game based on escape room; number=30), and control group (number=30). To generate a list of randomization, the online randomization service Sealed Envelope Ltd is used. The concealment of allocation is done using opaque envelopes that are sealed with a random sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pediatric airway management.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention Group One (Role-Playing with Simulation): In this group, educational content is presented to students through role-playing combined with simulation, done by the researcher and supervised by faculty members, in-person during a one-hour session. For this purpose, clinical scenarios are initially developed based on the educational goals and content. A 30-minute introductory session is first held in-person, during which the course outline, educational objectives, nature of the intervention, characteristics, implementation process, and rules are thoroughly explained to the students. Then, students are divided into groups of six, consisting of two medical students, two nursing students, and two emergency medicine students, with one member chosen by group consensus to act as the representative. The groups will proceed to five different stations when the bell rings, where each station contains a scenario involving a hypothetical child in need of airway management. The scenario is read by the group representative, and then the group members negotiate and discuss to reach a common solution. At each station, groups will have a limited role-playing opportunity of 10 minutes based on the scenario. At the end of the designated time, the performance, strengths, and weaknesses of the group will be identified and addressed by the facilitator. Intervention 2: Intervention group: Intervention Group: Intervention Group Two (Serious Game Based on Escape Room): Students in this group will receive educational content through a serious game based on an escape room. For this purpose, an initial 30-minute face-to-face briefing session will be held, during which the course plan, educational objectives, nature of the intervention, features, implementation process, and rules will be thoroughly explained to the students. Then, students will be divided into groups of six, with each group consisting of two medical students, two nursing students, and two paramedic students. Each group enters the escape room(s) to solve the designed challenges using their teamwork skills and knowledge. In each room, there is a scenario involving a hypothetical child who requires airway management. Each scenario consists of several stages and puzzles that group members must solve collaboratively at each stage, which includes selecting the appropriate technique, choosing the necessary equipment, and determining the size of the equipment needed for the hypothetical child. After solving each puzzle at each stage, they receive a clue for the next stage until they rescue the patient. Groups have a limited time of 30 to 60 minutes to solve the puzzles and ultimately rescue the patient and find the key to exit the room. It is worth mentioning that each group has one chance in each room and it cannot be repeated. In case of confusion among learners, facilitators present in each room will provide guidance. The escape room(s) used in this research are known as Pediatric Avengers - Airway Challenge and will be designed by a team consisting of a researcher and three faculty members (a supervisory professor and consultant colleagues). The design of these rooms is based on the escapeED model proposed by Clark and colleagues and includes 6 key elements: (1) learners, (2) goals, (3) theme, (4) puzzles, (5) equipment, and (6) assessment. Intervention 3: Control group: In the control group, no additional intervention will take place (training in the control group will be conducted as general training: including lectures, practical stations, and the use of models).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more data available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra taheri ezbarami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39841</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>zahra_taheri@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra taheri ezbarami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39841</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>zahra_taheri@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research.
the 6th and 7th years of professional medical students
Fourth-year nursing undergraduate students
Students in the 2nd, 3rd, and 4th years of continuous undergraduate medical emergency studies.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Experience of the company in the workshop on air way management for children
Experience in managing airways in children
Being employed in emergency and ICU</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention Group One (Role-Playing with Simulation): In this group, educational content is presented to students through role-playing combined with simulation, done by the researcher and supervised by faculty members, in-person during a one-hour session. For this purpose, clinical scenarios are initially developed based on the educational goals and content. A 30-minute introductory session is first held in-person, during which the course outline, educational objectives, nature of the intervention, characteristics, implementation process, and rules are thoroughly explained to the students. Then, students are divided into groups of six, consisting of two medical students, two nursing students, and two emergency medicine students, with one member chosen by group consensus to act as the representative. The groups will proceed to five different stations when the bell rings, where each station contains a scenario involving a hypothetical child in need of airway management. The scenario is read by the group representative, and then the group members negotiate and discuss to reach a common solution. At each station, groups will have a limited role-playing opportunity of 10 minutes based on the scenario. At the end of the designated time, the performance, strengths, and weaknesses of the group will be identified and addressed by the facilitator.</i_keyword>
      <i_keyword>Intervention group: Intervention Group: Intervention Group Two (Serious Game Based on Escape Room): Students in this group will receive educational content through a serious game based on an escape room. For this purpose, an initial 30-minute face-to-face briefing session will be held, during which the course plan, educational objectives, nature of the intervention, features, implementation process, and rules will be thoroughly explained to the students. Then, students will be divided into groups of six, with each group consisting of two medical students, two nursing students, and two paramedic students. Each group enters the escape room(s) to solve the designed challenges using their teamwork skills and knowledge. In each room, there is a scenario involving a hypothetical child who requires airway management. Each scenario consists of several stages and puzzles that group members must solve collaboratively at each stage, which includes selecting the appropriate technique, choosing the necessary equipment, and determining the size of the equipment needed for the hypothetical child. After solving each puzzle at each stage, they receive a clue for the next stage until they rescue the patient. Groups have a limited time of 30 to 60 minutes to solve the puzzles and ultimately rescue the patient and find the key to exit the room. It is worth mentioning that each group has one chance in each room and it cannot be repeated. In case of confusion among learners, facilitators present in each room will provide guidance. The escape room(s) used in this research are known as Pediatric Avengers - Airway Challenge and will be designed by a team consisting of a researcher and three faculty members (a supervisory professor and consultant colleagues). The design of these rooms is based on the escapeED model proposed by Clark and colleagues and includes 6 key elements: (1) learners, (2) goals, (3) theme, (4) puzzles, (5) equipment, and (6) assessment.</i_keyword>
      <i_keyword>Control group: In the control group, no additional intervention will take place (training in the control group will be conducted as general training: including lectures, practical stations, and the use of models).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of the children's airway management knowledge in the knowledge questionnaire. Timepoint: Immediately after the intervention. Method of measurement: The questionnaire consists of 30 items that assess students' knowledge regarding airway management in children across 5 domains (Table 4). Each item is answered based on a 4-option scale (one correct answer, two incorrect answers, and one 'I don’t know' option). A correct answer receives a score of +1, an incorrect answer receives a score of -0.5, and an 'I don’t know' answer receives a score of zero.</prim_outcome>
      <prim_outcome>Children's airway management performance score based on the checklist. Timepoint: Immediately after the intervention. Method of measurement: The performance checklist consists of 56 items that evaluate performance across 3 domains (Table 5). Each item contains two options: Yes and No. If the individual correctly performs the clinical process, the Yes option is marked; if unable to perform correctly, the No option will be completed by the evaluator.</prim_outcome>
      <prim_outcome>The level of satisfaction with the teaching method in the satisfaction questionnaire. Timepoint: Immediately after the intervention. Method of measurement: The satisfaction questionnaire comprises 8 items that measure students' satisfaction regarding the teaching method used for airway management in children. Each item is answered based on a 5-option scale: Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), and Strongly Agree (5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Guilan University of Medical Sciences Rasht Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-18</approval_date>
        <contact_name>Ethics Committee in Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology ,Old Building, School of Health, Shahid Siadati Avenue, Namjoo St.Guilan,Rasht,Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
