<?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>IRCT20170827035918N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Impact of web-based patient safety training to nursing managers on patient safety culture in nurses</public_title>
      <acronym></acronym>
      <scientific_title>Impact of web-based patient safety training to nursing managers on patient safety culture in nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73931</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: selecting hospitals (Imam Khomeini in one group, Sina and Shariati in another group) through simple dice sampling method 
selecting nursing staff (nurses and nursing assistants) through Table of random sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>No diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Individuals who join the intervention group receive the following training. The content is a combination of relevant sections on patient safety in nursing and management textbooks, patient safety culture questionnaires, clinical guidelines provided by the World Health Organization, and the literature review. The training includes patient safety and its culture, communication and feedback regarding errors, organizational learning, teamwork, error reporting, risk assessment and management, drug adverse effects and interactions, infection control, nursing leadership and safety leadership, and managerial support for patient safety. The training is presented to the head nurses intervention group only in six 30-40 minute sessions over a period of 6-12 weeks through media. The electronic content is prepared under the supervision of the research team and will be controlled by nursing management group of the nursing and midwifery faculty members as well as the virtual education group of the university. The potential platform is in the university's educational system. Each individual has their own password and access code. After logging into their personal page, each person have access to the content of the session they need. The educational content cannot be downloaded and individuals have online access to it. The educational content of each session is updated weekly. A message is sent each week as reminder and motivation. Individuals are given two weeks to study the content of each session. It should be noted that the content of the next session is only accessible only if  they answer the questions at the end of each session. Head nurses can this opportunity to ask their question.  Pre-test is taken before starting the first session, and post-test is taken two weeks and six weeks after providing the training from all participants (head nurses and nursing staff). Intervention 2: Control group: people who allocate to control group receives no training. They are just asked to do pre and post tests at the beginning and end of  training in intervention group,.</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 data is potentially shareable after de-identifying individuals.

When:
Start access after printing the results

To whom:
No limitation.

Conditions:
The data can be used to plan empowerment programs for nurses and nursing managers.

Where to obtain:
zahrasajedi75@gmail.com        zahra sajedi  
nahid.nayeri@gmail.com         nahid dehghan nayeri

How to obtain:
Sending an email to the responsible author is enough.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sajedimonfared</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1079, Hakim buildings,  Bahonar Street, Ashrafi Esfahani highway, Hakim Gharb highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1473138714</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>zahrasajedi75@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Dehghan Nayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirkhani St. (East Nusrat), Tohid Square, School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>nahid.nayeri@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Head nurses: having the management position for at least 6 months, having at least a bachelor's degree, not participating in a similar management course, access to a smartphone or computer, willingness to participate in the study
Nursing staff/nurses: Having at least a bachelor's degree for nurses, including the title of nurse in their employment order, working as a nurse in hospital wards, access to a smartphone or computer, willingness to participate in the study
Nursing staff/nursing assistants: Having a certificate of nursing assistant, including the title of nursing assistant in their employment order, working as a nursing assistant in hospital wards, access to a smartphone or computer, willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Changing the management post</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>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Individuals who join the intervention group receive the following training. The content is a combination of relevant sections on patient safety in nursing and management textbooks, patient safety culture questionnaires, clinical guidelines provided by the World Health Organization, and the literature review. The training includes patient safety and its culture, communication and feedback regarding errors, organizational learning, teamwork, error reporting, risk assessment and management, drug adverse effects and interactions, infection control, nursing leadership and safety leadership, and managerial support for patient safety. The training is presented to the head nurses intervention group only in six 30-40 minute sessions over a period of 6-12 weeks through media. The electronic content is prepared under the supervision of the research team and will be controlled by nursing management group of the nursing and midwifery faculty members as well as the virtual education group of the university. The potential platform is in the university's educational system. Each individual has their own password and access code. After logging into their personal page, each person have access to the content of the session they need. The educational content cannot be downloaded and individuals have online access to it. The educational content of each session is updated weekly. A message is sent each week as reminder and motivation. Individuals are given two weeks to study the content of each session. It should be noted that the content of the next session is only accessible only if  they answer the questions at the end of each session. Head nurses can this opportunity to ask their question.  Pre-test is taken before starting the first session, and post-test is taken two weeks and six weeks after providing the training from all participants (head nurses and nursing staff).</i_keyword>
      <i_keyword>Control group: people who allocate to control group receives no training. They are just asked to do pre and post tests at the beginning and end of  training in intervention group,</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient safety culture. Timepoint: Before intervention. 2 and 6 weeks after intervention. Method of measurement: Hospital Survey on Patient Safety Culture.</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>2023-11-18</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>Tehran University of Medical Sciences, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
