<?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>IRCT20260926071201N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-14</date_registration>
      <primary_sponsor>Smart University of Medical Sciences</primary_sponsor>
      <public_title>Comparing Case-Based Learning and Lecture-Based Teaching for Medical Students in Virology</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Virtual Case-Based Learning with Virtual Lectures on Knowledge Gain and Satisfaction in Virology Among Medical Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93655</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Other design features: This study employed a two-period, two-sequence crossover design across eight educational topics in virology. Participants were randomly assigned to two equal groups (Group A and Group B). In the first phase, Group A received virtual case-based learning (CBL) for the first four topics, while Group B received virtual lectures on the same topics. In the second phase, the interventions were crossed over such that Group B received virtual CBL for the subsequent four topics, while Group A received virtual lectures on those topics. Knowledge retention was assessed via post-tests at the end of each session, and educational satisfaction was evaluated using a validated 20-item questionnaire, Randomization description: Participants were randomly assigned to one of two sequences (CBL-Lecture or Lecture-CBL) using simple random allocation. The unit of randomization was the individual student. The random sequence was generated using a computer-based random number generator. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes, which were opened only at the time of participant enrollment to ensure that neither the researchers nor the participants could predict the group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Medical education / Virology education.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Virtual Case-Based Learning (VCBL). Multimedia clinical case vignettes with guided questions were provided via the Navid LMS one week prior to sessions. Synchronous 45-minute virtual sessions (4 sessions in total) were held on Adobe Connect. Students worked in small breakout groups of 4-5 individuals for 15 minutes to discuss clinical findings, laboratory workups, and differential diagnoses, followed by instructor-facilitated whole-class discussions, synthesis, and structured feedback. Intervention 2: Control group: Virtual Lecture-Based Learning (LBL). Medical students received the same virology topics across 4 synchronous 45-minute virtual sessions delivered via Adobe Connect using conventional lecture delivery. Instructors presented structured didactic slides covering identical learning objectives, with interactive question-and-answer opportunities via microphone or text chat and key concept summaries at the conclusion of each session.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Deidentified individual participant data (IPD) related to knowledge assessment scores and satisfaction surveys, study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code (R scripts), and data dictionary.

When:
Data and documents will be available starting 6 months after the publication of the main study results and will remain available for 5 years.

To whom:
Available to researchers affiliated with academic or scientific institutions who provide a methodologically sound research proposal.

Conditions:
Data may be used for meta-analysis or secondary research purposes. Requests must include a clear research proposal, study objectives, and the intended use of the data. The request will be reviewed by the principal investigator to ensure compliance with participant privacy and ethical standards.

Where to obtain:
Interested researchers should contact the corresponding author via email at r_mojtahedzadeh@tums.ac.ir

How to obtain:
The applicant should submit a formal request via email, including their research proposal. The principal investigator will review the request for scientific validity and ethical adherence. The review process typically takes 2 to 4 weeks, and the applicant will be notified of the decision via email.

Comments:
None</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzin Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 1st Alley, Sarafraz St., Shahid Beheshti St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587656811</zip>
        <telephone>+98 21 8770 0004</telephone>
        <email>sadeghifarzin6@gmail.com</email>
        <affiliation>Department of Medical Education, Smart University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rita Mojtahedzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 1st Alley, Sarafraz St., Shahid Beheshti St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587656811</zip>
        <telephone>+98 21 8770 0004</telephone>
        <email>r_mojtahedzadeh@tums.ac.ir</email>
        <affiliation>Department of Medical Education, Smart University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Undergraduate medical students enrolled in the fourth semester
Official enrollment in the general medical virology course in the current semester
Written informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Prior history of failing or repeating the medical virology course
Prior participation in formal case-based learning courses or workshops in virology
Guest or transfer students who have previously completed this course at another university</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Virtual Case-Based Learning (VCBL). Multimedia clinical case vignettes with guided questions were provided via the Navid LMS one week prior to sessions. Synchronous 45-minute virtual sessions (4 sessions in total) were held on Adobe Connect. Students worked in small breakout groups of 4-5 individuals for 15 minutes to discuss clinical findings, laboratory workups, and differential diagnoses, followed by instructor-facilitated whole-class discussions, synthesis, and structured feedback.</i_keyword>
      <i_keyword>Control group: Virtual Lecture-Based Learning (LBL). Medical students received the same virology topics across 4 synchronous 45-minute virtual sessions delivered via Adobe Connect using conventional lecture delivery. Instructors presented structured didactic slides covering identical learning objectives, with interactive question-and-answer opportunities via microphone or text chat and key concept summaries at the conclusion of each session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Student knowledge score in medical virology. Timepoint: Immediately after each educational session across both study periods. Method of measurement: Multiple choice question knowledge assessment test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Student satisfaction with the teaching method. Timepoint: At the end of each teaching session in both study periods. Method of measurement: Self-administered satisfaction questionnaire using a five-point Likert scale.</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>Smart University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-08</approval_date>
        <contact_name>Ethics Committee of Virtual University of Medical Sciences</contact_name>
        <contact_address>No. 3, 1st Alley, Sarafraz St., Shahid Beheshti St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
