<?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>IRCT20231026059864N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of the training program based on the description on the attitude, performance surgical students and technologists</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of the training program based on the description in the management of technical errors in the operating room on the attitude, performance surgical students and technologists</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation law is the simplest limited randomization method. This method represents a large block for the entire sample volume, which means that the balance in the number of people allocated to each group is achieved at the end of the study. For this purpose of the study, they first selected a total sample size and then randomly assigned them to group A and the rest to group B. For example, in a study with a sample size of 200 people, one hundred balls for the intervention group A. And the 100 ball for intervention group B is placed in a lottery container and then a 100 ball is removed from the container without replacement and a sequence is created. This method is used for experiments with two or more groups, Blinding description: A training program related to patient safety is planned for all participants. The contents were similar in both groups, but the teaching method in one group was the routine lecture method, and in the other group, it was taught using scripts and puzzles. Therefore, in terms of what kind of training method it is and whether it is intervention or controlled in the group, the companies were not informed in advance, but about what training workshop they would participate in and the complete training topic was given to the companies. Also, in the analysis process, the data will be sent in coded form for data analysis, and they had no control over the code of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Teaching operating room safety errors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The teaching-learning methods in the intervention group included interactive lecture method, learning in small groups, and case-based learning and narrative strategy, and students actively participated in these sessions. The number of training sessions was 3. At this stage, students experienced case-based learning. For this purpose, students explained their suggestions and solutions after analyzing the case. The educational goals were determined by the students. The students reviewed the texts and reviewed the guides and guidelines of WHO and the country in the field of the relevant case. Students in each group presented their results and findings. Finally, the summary was done by the facilitator. In the second step, in the Strategy Script method, the students were asked to prepare a script template for each of the determined errors. These narrative templates were compiled by students in small groups and finally completed and summarized by the facilitator. Also, the description templates prepared in the first phase were provided to the students as a learning and summarizing tool so that all the steps that need to be paid special attention to in the decision-making process can be reviewed and reconsidered. Intervention 2: Control group: In order to implement the educational intervention, two groups of students will be included in the study at two points in time. The control group will receive training using lectures. For this purpose, all educational content and explained errors and patient safety guidelines will be taught in the form of a lecture.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohadeseh Sadat Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, in front of Moalem 8, Moalem St, Aysk city</address>
        <city>Ferdows</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9779118477</zip>
        <telephone>+98 56 3287 4492</telephone>
        <email>m.mehrdad@stu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohadeseh Sadat Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, in front of Moalem 8, Moalem St, Aysk city</address>
        <city>Ferdows</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9779118477</zip>
        <telephone>+98 56 3287 4492</telephone>
        <email>m.mehrdad@stu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Surgical technologists working in the operating room of teaching hospitals
Students of the 5th semester of the bachelor's degree in the operating room field
Students of the 7th semester of the bachelor's degree in the operating room field
Age 18 to 60 years with healthy general condition
Signing the consent form period to cooperate in the entire study based on the study protocol</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of participating in training courses about safety errors in the operating room
Unwillingness to participate in the study</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The teaching-learning methods in the intervention group included interactive lecture method, learning in small groups, and case-based learning and narrative strategy, and students actively participated in these sessions. The number of training sessions was 3. At this stage, students experienced case-based learning. For this purpose, students explained their suggestions and solutions after analyzing the case. The educational goals were determined by the students. The students reviewed the texts and reviewed the guides and guidelines of WHO and the country in the field of the relevant case. Students in each group presented their results and findings. Finally, the summary was done by the facilitator. In the second step, in the Strategy Script method, the students were asked to prepare a script template for each of the determined errors. These narrative templates were compiled by students in small groups and finally completed and summarized by the facilitator. Also, the description templates prepared in the first phase were provided to the students as a learning and summarizing tool so that all the steps that need to be paid special attention to in the decision-making process can be reviewed and reconsidered.</i_keyword>
      <i_keyword>Control group: In order to implement the educational intervention, two groups of students will be included in the study at two points in time. The control group will receive training using lectures. For this purpose, all educational content and explained errors and patient safety guidelines will be taught in the form of a lecture.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attitude score of the participants. Timepoint: At the beginning of the study (before the start of the intervention) and two weeks and two months after the educational intervention. Method of measurement: Hospital survey on patient safety culture (HSOPSC) questionnaire.</prim_outcome>
      <prim_outcome>Performance score of the participants. Timepoint: At the beginning of the study (before the start of the intervention) and two weeks and two months after the educational intervention. Method of measurement: World Health Organization Behaviourally Anchored Rating Scale(WHOBARS) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Participants' diagnostic skills score. Timepoint: At the beginning of the study (before the start of the intervention) and two weeks and two months after the educational intervention. Method of measurement: Key feature questions.</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>2023-06-17</approval_date>
        <contact_name>Ethics committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Imam Reza Complex, 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>
