<?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>IRCT20150715023216N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation Of The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48331</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Prior to the intervention, 44 staff members of Al-Zahra Hospital operating room will enter the study according to their inclusion criteria. These 44 operating room staff will then be assigned random numbers 1 to 44, and they will be randomly assigned (even and odd numbers) in two intervention group (22 people) and control group(22 people). Accidental sampling is done by randomly assigning them to numbers 1 to 44 and placing them in two groups based on even and odd. The control group will use the routine method of organizing surgical sutures. The routine method of arranging surgical sutures is to place the surgical sutures after each use, on the surgical table or on a gas to arrange the surgical sutures and make them available.The intervention group will use the tools to arrange the surgical sutures, Blinding description: The data analyzer is kept blind. After collecting the data in the intervention and control groups, the data was provided to the analyzer and he did not know the type of intervention and the randomization and placement of samples in the groups. .</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of using surgical instruments.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The operating room staff is in the role of scrub who use the tools of organizing surgical sutures. After randomization, and placing the samples in the intervention and control groups, the  intervention group will use the surgical suture arrangement tool. The test group will be taught how to use the tool. Before and after the intervention, the self-efficacy questionnaire was completed by the experimental group; A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the experimental group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests. Intervention 2: Control group: The operating room staff is in the role of scrub who use the routine method to arrange the surgical sutures. The routine method involves holding the surgical sutures on a sterile gauze on the operating table or on the operating table. Before and after the intervention, the self-efficacy questionnaire is completed by the control group. A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the control group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests.</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>Ahmad Ghadami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3792 7550</telephone>
        <email>ghadami@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Ghadami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3792 7550</telephone>
        <email>ghadami@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants in the project, including the scrub person in the intervention group, have received the necessary training to use the tool.
The scrub person should work in the fields of general , vascular, neurological, orthopedic, pediatric, cosmetic, ENT and gynecology surgery.
The scrub person should scrub in surgeries that have more than 3 surgical sutures on the operating table.
The scrub person should use the method of organizing surgical sutures in at least 3 surgeries.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of willingness of the surgical team to continue cooperation in research.
Operating room personnel not be present in the operating room during the study for any reason, such as parental leave, etc.
Using an other method except the routine method and except the tools of organizing surgical threads for maintaining and arranging surgical threads.</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 operating room staff is in the role of scrub who use the tools of organizing surgical sutures. After randomization, and placing the samples in the intervention and control groups, the  intervention group will use the surgical suture arrangement tool. The test group will be taught how to use the tool. Before and after the intervention, the self-efficacy questionnaire was completed by the experimental group; A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the experimental group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests.</i_keyword>
      <i_keyword>Control group: The operating room staff is in the role of scrub who use the routine method to arrange the surgical sutures. The routine method involves holding the surgical sutures on a sterile gauze on the operating table or on the operating table. Before and after the intervention, the self-efficacy questionnaire is completed by the control group. A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the control group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this study, self-efficacy is measured in two groups of operating room personnel in the role of scrub. Timepoint: Before and after the intervention. Method of measurement: Researcher made a questionnaire.</prim_outcome>
      <prim_outcome>In this study, Satisfaction is measured in two groups of operating room personnel in the role of scrub. Timepoint: after the intervention. Method of measurement: Researcher made a questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-05</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib Street isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
