<?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>IRCT20260905070919N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Medical Students’ Cognitive Processing of Pre-Study Stimuli in a Flipped Classroom Environment And Determining Their Structural Relationships: A Mixed-Methods Study</public_title>
      <acronym></acronym>
      <scientific_title>Medical Students’ Cognitive Processing of Pre-Study Stimuli in a Flipped Classroom Environment And Determining Their Structural Relationships: A Mixed-Methods Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/93688</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Following the identification of eligible participants and obtaining informed consent, participants will be allocated to the intervention and control groups using a randomization method based on colored cards.

For this purpose, four card colors will be assigned to the respective groups (red, yellow, blue, and green). During the first session, an equal number of cards in each of the four colors, corresponding to the total number of students in the class, will be placed on a table. As the students will be unaware of the group assignments, each student will select one of the colored cards, and their name and the color of the selected card will be recorded. Accordingly, they will be allocated to the four intervention and control groups, and no further information regarding the group assignments will be provided to them until the intervention begins.

Although the researcher must be aware of the group assignments for the purpose of study management, to prevent allocation bias and ensure observer blinding, the researcher responsible for data analysis and the examiner responsible for scoring the tests will remain blinded to the participants’ group assignments (assessor blinding).

Each student will remain in the assigned group throughout all intervention sessions. To control for bias arising from differences in the scientific content of the sessions, the subtopics will be matched in terms of volume, complexity, and prerequisite knowledge; a pre-class readiness test will be administered at the beginning of each session; and the variable “session/content” will be included as a repeated factor in the statistical analyses, Blinding description: Due to the nature of the educational interventions, double-blinding is not feasible. The students and instructor will be aware of the group assignments, which may influence their behavior and performance; this will be acknowledged as a limitation of the study. To address this limitation, data analyst blinding will be implemented. The data analyst will be unaware of the group assignments, and the data will be provided using numerical codes. The use of an active control group (rather than no intervention) to reduce expectancy effects, as well as the explicit documentation and reporting of the blinding status in the final report, are additional strategies for addressing this limitation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>پردازش شناختی.</hc_freetext>
      <i_freetext>Intervention group: Group A must complete a guided reflection activity (one-minute paper) after studying the pre-class content and based on it, before attending the class, and submit the completed activity in the homework section of the Navid system no later than one day before the class. These responses are reviewed by the researcher to confirm the completion of the activity (without grading).The method of doing the activity is as follows: students must answer the following two questions based on the rules of the one-minute paper method:1- "What was the most important thing you learned from this content?"2- "What question remained for you after studying?"In group B, students design a crossword puzzle themselves after studying the pre-class content, and no later than one day before the class, and then solve it and submit the results via the Navid electronic system. The activity will not be graded again.This activity includes:• Selecting at least 8 key anatomical concepts (renal block)• Generating meaningful clues for each concept• Designing a table in which words intersect horizontally and vertically• And solving the table to receive internal feedback on the correctness of the connection between the concepts.In Group C, after studying the pre-class content and up to one day before the class, students participate in an interactive quiz that is uploaded to the Navid system as a short 5-question multiple-choice test. The questions are randomly selected from the question bank related to the session content and the answers are provided immediately with immediate feedback (true / false with a short explanation).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj, Shahin Villa, Bahonar Square, North Bahman 22nd Street, Shahid Pasha Zanussi Alley, No. 51, 3rd floor</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3195717547</zip>
        <telephone>+98 26 3484 2436</telephone>
        <email>m.shiri@abzums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj, Shahin Villa, Bahonar Square, North Bahman 22nd Street, Shahid Pasha Zanussi Alley, No. 51, 3rd floor</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3195717547</zip>
        <telephone>+98 26 3483 2436</telephone>
        <email>m.shiri@abzums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Second-year medical students at Tehran University of Medical Sciences will be enrolled in the study if they meet the following criteria: Official registration for the Anatomy course (Renal Block) during the semester under study
No previous completion of this educational block
Provision of informed consent to participate in the study
Active access to the university’s electronic learning management system (Navid)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate or failure to provide informed consent
Lack of stable access to the university’s electronic learning management system
Absence from the initial study orientation session</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A must complete a guided reflection activity (one-minute paper) after studying the pre-class content and based on it, before attending the class, and submit the completed activity in the homework section of the Navid system no later than one day before the class. These responses are reviewed by the researcher to confirm the completion of the activity (without grading).The method of doing the activity is as follows: students must answer the following two questions based on the rules of the one-minute paper method:1- "What was the most important thing you learned from this content?"2- "What question remained for you after studying?"In group B, students design a crossword puzzle themselves after studying the pre-class content, and no later than one day before the class, and then solve it and submit the results via the Navid electronic system. The activity will not be graded again.This activity includes:• Selecting at least 8 key anatomical concepts (renal block)• Generating meaningful clues for each concept• Designing a table in which words intersect horizontally and vertically• And solving the table to receive internal feedback on the correctness of the connection between the concepts.In Group C, after studying the pre-class content and up to one day before the class, students participate in an interactive quiz that is uploaded to the Navid system as a short 5-question multiple-choice test. The questions are randomly selected from the question bank related to the session content and the answers are provided immediately with immediate feedback (true / false with a short explanation)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The status of students' cognitive processing will be measured based on the following criteria: • Quantitative and qualitative indicators of content recall • Pre-class readiness • Immediate retrieval performance • Spaced retrieval performance • Forgetting rate • Metacognitive accuracy. Timepoint: 1. Pre-class preparation and immediate retrieval: At the beginning of the flipped class session, through the pre-class preparation test2. Content review assignment: At the beginning of each flipped class session 3. Content review assignment: At the end of each flipped class session 4. Spaced learning: At the end of the academic year and simultaneously with the official final exam of the anatomy course (renal block), so that the scores related to the questions related to the topics of the intervention sessions will be used as an indicator of long-term retention of knowledge in the research analysis.5. Metacognitive accuracy at the end of the semester after assessing students' performance on the final exam 6. Forgetting rate at the end of the semester after assessing students' performance on the final exam This multi-temporal design allows for the examination of the effects of interventions on different stages of information processing, including encoding, consolidation, and retrieval of knowledge. Method of measurement: In this study, cognitive processing as a multidimensional construct is calculated by combining and scoring the following indicators for each student: Encoding depth index: cognitive creativity score (based on the number of innovative connections and structured organization of concepts in the content retrieval task). Monitoring accuracy index: metacognitive accuracy score (calculated through Spearman correlation and calibration error between confidence score and actual performance). Retrieval efficiency index: knowledge development score (based on the number of key concepts identified, accuracy in numbering, and completeness of content coverage in retrieval, which indicates success in the active retrieval process). Readiness is defined as the score students take on the Readiness Assessment Test (RAT). This test consists of 4 to 6 multiple-choice questions with a difficulty level similar to that of the end-of-term exam, administered in writing at the beginning of each class session (after the pre-study phase). The test questions assess students’ understanding of the pre-class content (including videos or educational texts) in the anatomy course (renal block). Each question carries a score, and the average RAT scores over the semester are used as an overall indicator of “readiness” for statistical analysis. This test will serve a dual purpose, assessing students’ readiness as well as their immediate retrieval performance. Immediate retrieval performance refers to the student's performance on the cognitive readiness test that will be administered at the beginning of class sessions. In order to prevent increased cognitive and work load on students, the readiness test and immediate performance test will be administered as a single test at the beginning of class sessions. A similar retrieval test (with the same questions or meaningful equivalents) is administered at the end of the academic semester. The student's score on the flipped classroom sections is the spaced retrieval performance. The forgetting rate is calculated based on the principles of the founder of memory psychology, Ernst Ebbinghaus, and inspired by modern research on spaced retrieval and the method of calculating forgetting rates in the Wickstead (1992) study (95). This index is defined as a quantitative measure of the rate of learning loss over time. The forgetting rate for each participant is calculated by subtracting the spaced retrieval test score from the immediate retrieval test score and dividing the result by the immediate test score (multiplying by 100). In this formula, the immediate retrieval score indicates the amount of initial learning and the spaced retrieval score indicates the amount of knowledge retained in the long term. This index is used as a measure of the stability of learning and the persistence of knowledge in long-term memory.The lower the forgetting rate in the intervention groups compared to the control group, the higher the effectiveness of that intervention in consolidating learning. In this study, the JOL instrument is designed as an item-based instrument. This instrument is self-reported and is such that after each question of the readiness test (immediate retrieval test), the student also answers the following question: "How confident are you that you can answer the question on this topic correctly on the final exam?" Students are asked to record their level of confidence (for example, on a Likert scale of 0 to 2, where 0 is not at all confident, 1 is somewhat confident, and 2 is completely confident). The total score will be the average of the number of responses. In order to measure metacognitive accuracy, two quantitative indicators are used:1. Spearman correlation: It is calculated between confidence scores and actual performance scores to measure the student's ability to distinguish between knowledge and ignorance.2.Calibration error: Calculated as the absolute difference between the mean confidence score and the mean actual performance to assess the student's degree of systematic optimism or pessimism. In the final analysis, a higher score in Spearman's correlation and a lower score in calibration error indicate more favorable metacognitive accuracy. Knowledge development is defined as the score students receive from the content review assignment. In this assignment, students are asked to write down all the key words or concepts related to the session topic on a sheet of paper and to indicate a specific numbering for each concept (according to the structure provided in the pre-class resources). This assignment is collected from students at the beginning and end of each flipped classroom session. Scoring is done in three areas based on calculating the number of key concepts identified, accuracy in numbering and completeness of session content coverage, conceptual errors, and cognitive creativity (maximum score for each assignment: 10). The scores students receive from this assignment at the beginning and end of class and their averages are calculated, and the average scores for each session throughout the semester are used as an indicator of “knowledge development.”Correction and evaluation are carried out by two independent evaluators and, in case of disagreement, by a third evaluator.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-25</approval_date>
        <contact_name>Research Ethics Committee, Faculty of Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Medicine faculty, Pur Sina Ave, Qods Ave, Enghelab Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
