<?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>IRCT20250623066225N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-16</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Impact of Analog Simulation Game on Nursing Students' Diabetes Education for Older Adults</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Simulation with Analog Game on the Knowledge and Skills of Nursing Students in Teaching the Elderly with Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84725</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization Method: Cluster randomization
Unit of Randomization: Cluster-based, with approximately 4-student clinical/workshop groups formed based on students’ preferences and natural grouping during the semester
Stratification: Not applied
Randomization Tool: Online tool random.org/sequences and sealed, numbered envelopes for concealment
Random Sequence Generation: A list of clinical training groups was created based on the academic schedule. Random allocation sequence was generated using the online tool and placed into individually sealed envelopes labeled by group number
Allocation Concealment: Only the group number was visible on the envelopes. The intervention/control status was concealed until the envelope was opened by the student, who then reported the assigned group to the researcher, Blinding description: In this way, the pre-test and post-test evaluators do not know which group (intervention or control) the students are in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Type 2 diabetes. Condition 2: Lifestyle and self-care problems in older adults with diabetes. Condition 3: Training nurses and nursing students in self-care and monitoring the elderly. Condition 4: Knowledge and skills of nursing students in educating and counseling elderly people with type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention for the experimental group consists of two main stages. In the first stage, educational sessions on “communication and education for elderly patients with type 2 diabetes” are held for all students in both groups. These sessions are delivered by the second researcher (a student), under the guidance and supervision of academic advisors, and take place in two structured two-hour meetings. The session content follows a pre-designed lesson plan attached to the study protocol. In the second stage, a structured educational simulation is designed and implemented exclusively for the intervention group, incorporating an analog board game. Students participate in this game in groups of four. The game aims to enhance students’ cognitive and attitudinal skills in elderly diabetes care, incorporating elements such as playing cards, coins, and special “client encounter” cards. The game is competitive, with players acting as rivals, and the first player to reach 30 points is declared the winner. The game is supervised by the principal researcher, academic supervisors, and, if needed, trained senior students or instructors. Each card is numbered and includes a point value (top left), a replacement coin type (top right), and a cost (center of the card) based on the number and type of coins. Players must answer questions based on taxonomic levels to earn coins and purchase cards. The correct answers are available to the game supervisor. Once a player reaches 10 points, a client encounter card becomes available. These cards include a written simulation scenario, and the student must perform a role-play teaching session for an elderly patient and their family. Other students assist in the role-play but do not earn points. The performance is evaluated by the supervisor using a structured checklist, with a maximum of 10 points awarded in this phase. There are three types of coins: gold (taxonomy level 3), silver (level 2), and bronze (level 1). Correct answers to questions of each level grant the corresponding coin. To buy a card, students must spend the indicated coins, and the used coins are returned to the pool. Each game round includes four students and one supervisor. Several game sessions may be conducted simultaneously under the supervision of multiple evaluators. Since each question is followed by immediate feedback, the content is reinforced for all group members, supporting collaborative learning. The game continues until one student reaches 30 points and is declared the winner. Intervention 2: Control group: Communication and education sessions for elderly people with type 2 diabetes (similar to the first phase of the intervention group) will be held for students by the second researcher (student) and with the guidance and supervision of the supervisors during two two-hour sessions.</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:
All personal data of study participants can be shared after de-identification. Data sharing is done by uploading to official data sharing databases or by requesting the applicant in the form of an email to the corresponding author.

When:
6 months after publication of the article

To whom:
The data will be available to researchers working in academic and scientific institutions.

Conditions:
For scientific application and use for systematic review studies

Where to obtain:
Fatemeh Bakhshi, Yazd, Bu Ali St., Safaieh, Shahid Sadoughi Faculty of Nursing and Midwifery, Nursing and Midwifery Care Research Center Postal Code: 8916877443 Contact Phone: 0098 9139684626 Email Address: Fateme.bakhshii@gmail.com f.bakhshi@ssu.ac.ir

How to obtain:
One week after the applicant's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 1751 3824</telephone>
        <email>fateme.bakhshii@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 1751 3824</telephone>
        <email>fateme.bakhshii@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Passing theoretical courses and internships in adult health nursing (internal surgery) 1 to 3, patient education courses and taking adult health nursing courses 4 and home care nursing and individual, family, environmental and community health nursing courses</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Students who are on leave or sick leave</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>Z72.9</hc_code>
      <hc_code>Z74.3</hc_code>
      <hc_code>Z71.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
      <hc_keyword>Problem related to lifestyle, unspecified</hc_keyword>
      <hc_keyword>Need for continuous supervision</hc_keyword>
      <hc_keyword>Other specified counseling</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention for the experimental group consists of two main stages. In the first stage, educational sessions on “communication and education for elderly patients with type 2 diabetes” are held for all students in both groups. These sessions are delivered by the second researcher (a student), under the guidance and supervision of academic advisors, and take place in two structured two-hour meetings. The session content follows a pre-designed lesson plan attached to the study protocol. In the second stage, a structured educational simulation is designed and implemented exclusively for the intervention group, incorporating an analog board game. Students participate in this game in groups of four. The game aims to enhance students’ cognitive and attitudinal skills in elderly diabetes care, incorporating elements such as playing cards, coins, and special “client encounter” cards. The game is competitive, with players acting as rivals, and the first player to reach 30 points is declared the winner. The game is supervised by the principal researcher, academic supervisors, and, if needed, trained senior students or instructors. Each card is numbered and includes a point value (top left), a replacement coin type (top right), and a cost (center of the card) based on the number and type of coins. Players must answer questions based on taxonomic levels to earn coins and purchase cards. The correct answers are available to the game supervisor. Once a player reaches 10 points, a client encounter card becomes available. These cards include a written simulation scenario, and the student must perform a role-play teaching session for an elderly patient and their family. Other students assist in the role-play but do not earn points. The performance is evaluated by the supervisor using a structured checklist, with a maximum of 10 points awarded in this phase. There are three types of coins: gold (taxonomy level 3), silver (level 2), and bronze (level 1). Correct answers to questions of each level grant the corresponding coin. To buy a card, students must spend the indicated coins, and the used coins are returned to the pool. Each game round includes four students and one supervisor. Several game sessions may be conducted simultaneously under the supervision of multiple evaluators. Since each question is followed by immediate feedback, the content is reinforced for all group members, supporting collaborative learning. The game continues until one student reaches 30 points and is declared the winner.</i_keyword>
      <i_keyword>Control group: Communication and education sessions for elderly people with type 2 diabetes (similar to the first phase of the intervention group) will be held for students by the second researcher (student) and with the guidance and supervision of the supervisors during two two-hour sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Pre-test and Post-test. Method of measurement: Measuring the level of knowledge on the topic of self-care education in elderly people with diabetes includes a test containing 23 questions and is researcher-made.</prim_outcome>
      <prim_outcome>Skill. Timepoint: Pre-test and Post-test. Method of measurement: The OSCA assessment checklists and questions for each station include three checklists and three 10-minute stations. The scenario questions and checklists are researcher-created.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction. Timepoint: After the completion of the educational course. Method of measurement: Satisfaction survey questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-15</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Imam Reza Complex, Research and Technical Assistant, Imam Hossein Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
