<?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>IRCT20200713048090N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of educational escape room on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational escape room on health literacy and self-efficacy of patients with type II diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49656</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The time block method is used to allocate research units. Random sequence is pre-determined by SPSS software for at least 20 days and stored in a package. Every morning, the door of the envelope is opened and based on the relevant code, it will be determined in which group all the patients will be in that day.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabete.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: to design an educational escape room based on the frameworks presented in the articles, first the educational needs of patients will be examined by reviewing texts, oral questions from officials and patients at the time of completing the personal information questionnaire, and after extracting items and Preparing a checklist, their validity will also be checked and approved. Then learning goals are planned. Based on the needs, educational goals and the level of knowledge and skills of the participants, the subject of education, narration, game structure and puzzles and their level of difficulty are designed. These puzzles will be narrative-based challenges with a linear structure so that all members of the group can work together to solve each problem at the same time. The physical space in a room at the Parsian Diabetes Center in Mashhad is designed based on learning objectives, puzzles and their narration with appropriate visual effects. In order to evaluate the room before the main meetings, the two groups enter the escape room on a trial and consecutive basis, which is ready for the main intervention after making the necessary corrections. In the intervention group, individuals are divided into groups of 4-6 people based on the same age category and by gender. For each group, a training session with a lecture method with slides and questions and answers for 60 minutes on the topic of diabetes control and self-care is held by the researcher. Before entering the educational escape room, explanations about the rules, scenarios and instructions will be given orally in 5 minutes, which are also available in writing in the room. They then work together to solve problems and puzzles in the room for a maximum of 60 minutes using the instructions given to get the final key to leave the room. The observer (the researcher himself, who also teaches the lecture session) is present with the participants in the room to monitor the performance, provide guidance and measure time, and if he sees a performance error, he will not allow progress until it is corrected. Whenever they need help or clues, they can ask the game supervisor, who will be provided with a minute to add time. Also, if they do not make progress in the first 30 minutes, the game supervisor will guide them. After reaching the final key and leaving the meeting room for 20 minutes to provide feedback, explain mistakes, fix problems, express learning experiences and satisfaction of participants in a group discussion and using the evaluation checklist of the escape room, along with The reception will be held and the relevant questionnaires will be completed. Intervention 2: Control group: in the control group, two training sessions (45-60 minutes) will be held by the researcher in the form of lectures by presenting slides and questions and answers during a day with an interval of half an hour (for rest and reception) in groups of 8-12 people. The content and educational objectives will be similar to the intervention group. Finally, people's opinions and learning experiences are checked with a checklist.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faeze Mardani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school, Ebnesina avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mardanif971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Mazloum</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school, Ebnesina avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mazlomr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness and satisfaction to participate in the study
Living in Mashhad at the time of research
Age 18 to 63 years
Ability to participate in the training program
Diagnosis of type 2 diabetes by a specialist doctor
At least 3 months have passed since the diagnosis of diabetes
Have a minimum literacy rate
No severe complications (nephropathy, retinopathy, vasculopathy and neuropathy)
History of drug treatment of diabetes
Be alert and able to communicate verbally and non-verbally.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>63 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with continuing to participate in the study
Absence from any training sessions
Acute problems such as severe stress or illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: to design an educational escape room based on the frameworks presented in the articles, first the educational needs of patients will be examined by reviewing texts, oral questions from officials and patients at the time of completing the personal information questionnaire, and after extracting items and Preparing a checklist, their validity will also be checked and approved. Then learning goals are planned. Based on the needs, educational goals and the level of knowledge and skills of the participants, the subject of education, narration, game structure and puzzles and their level of difficulty are designed. These puzzles will be narrative-based challenges with a linear structure so that all members of the group can work together to solve each problem at the same time. The physical space in a room at the Parsian Diabetes Center in Mashhad is designed based on learning objectives, puzzles and their narration with appropriate visual effects. In order to evaluate the room before the main meetings, the two groups enter the escape room on a trial and consecutive basis, which is ready for the main intervention after making the necessary corrections. In the intervention group, individuals are divided into groups of 4-6 people based on the same age category and by gender. For each group, a training session with a lecture method with slides and questions and answers for 60 minutes on the topic of diabetes control and self-care is held by the researcher. Before entering the educational escape room, explanations about the rules, scenarios and instructions will be given orally in 5 minutes, which are also available in writing in the room. They then work together to solve problems and puzzles in the room for a maximum of 60 minutes using the instructions given to get the final key to leave the room. The observer (the researcher himself, who also teaches the lecture session) is present with the participants in the room to monitor the performance, provide guidance and measure time, and if he sees a performance error, he will not allow progress until it is corrected. Whenever they need help or clues, they can ask the game supervisor, who will be provided with a minute to add time. Also, if they do not make progress in the first 30 minutes, the game supervisor will guide them. After reaching the final key and leaving the meeting room for 20 minutes to provide feedback, explain mistakes, fix problems, express learning experiences and satisfaction of participants in a group discussion and using the evaluation checklist of the escape room, along with The reception will be held and the relevant questionnaires will be completed.</i_keyword>
      <i_keyword>Control group: in the control group, two training sessions (45-60 minutes) will be held by the researcher in the form of lectures by presenting slides and questions and answers during a day with an interval of half an hour (for rest and reception) in groups of 8-12 people. The content and educational objectives will be similar to the intervention group. Finally, people's opinions and learning experiences are checked with a checklist</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health literacy score in the comprehensive diabetes health literacy Scale. Timepoint: Before the training session, immediately and two weeks later. Method of measurement: Comprehensive Diabetes Health Literacy Scale.</prim_outcome>
      <prim_outcome>Self-efficacy score on the diabetes self-efficacy scale. Timepoint: Before the training session, immediately and two weeks later. Method of measurement: Confidence in Diabetes self-Care Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-12</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central Building Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
