<?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>IRCT20230301057573N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-23</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of lecture and jigsaw  training on nurses' attitudes towards delirium and the ability to screen for delirium.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Lecture and Jigsaw Training on Nurses' Attitude towards Delirium and the Ability to Screen for Delirium in the Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68889</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization is done using Excel software and random number function.
One hospital is selected for the  first intervention group (jigsaw training) and the other hospital for the second group (lecture training).
Random allocation will be done by the method of random sequence generation by random number table in Excel software. In the Excel software page, the left column, the total number of participants shows that there are 80 people in the present study. The next column indicates the group to which the participants belong, using which the top half will eventually belong to group A and the bottom half to group B. In the following, after identifying the people in two groups, to cover the allocation to the two groups, two dark and closed and completely similar envelopes are used, in one envelope the name of hospital A and in the second envelope, the name of hospital B is written and randomly one The envelope is selected and the selected hospital is selected for the first intervention (jigsaw) and accordingly the second hospital is selected for the second intervention (lecture).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delirium in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group (lecture): In this group, education related to delirium includes the definition and types of delirium in the ICUs, identification methods of delirium, important interventions in the prevention and care of patients, and appropriate treatment and care methods, etc. for two sessions of 30 minutes. It is presented to nurses through a lecture and PowerPoint and movie screening by the researcher. Intervention 2: The second intervention group: in the jigsaw learning method, nurses are divided into groups of 3 to 5 people. Delirium topics are presented in 4 sessions of 30 minutes. Every week, according to the PowerPoint chapter and educational video designed, nurses will be informed about the topic and all members of the group will study the desired topic. After the meeting, one group leader will be selected from each group and the educational content will be presented to them through the researcher. Then the specified members of each group will form a group of experts together and will review the desired educational topic with their participation and have a comprehensive review of the concepts of the topic and master the components of the topic in the presence of the researcher. The group will return and present the concepts to their group members, and then the researcher will summarize the topics and this process will continue for four weeks.</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>Neda Sanaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Hashemi Rafsanjani Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>nedasanaie@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Sanaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Hashemi Rafsanjani Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>nedasanaie@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least a bachelor's degree in nursing
Have at least one year of clinical work experience in the intensive care unit
They have not completed a training course related to delirium in the past year
Due to the importance of having at least one year of work experience in the ICU, the age of entering the study is 23 years and older.</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Leave the intensive care unit before completing the study for any reason
Have not completed the questionnaires completely
Absence of more than one session during the presentation of the educational program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F13.221</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sedative, hypnotic or anxiolytic dependence with intoxication delirium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group (lecture): In this group, education related to delirium includes the definition and types of delirium in the ICUs, identification methods of delirium, important interventions in the prevention and care of patients, and appropriate treatment and care methods, etc. for two sessions of 30 minutes. It is presented to nurses through a lecture and PowerPoint and movie screening by the researcher.</i_keyword>
      <i_keyword>The second intervention group: in the jigsaw learning method, nurses are divided into groups of 3 to 5 people. Delirium topics are presented in 4 sessions of 30 minutes. Every week, according to the PowerPoint chapter and educational video designed, nurses will be informed about the topic and all members of the group will study the desired topic. After the meeting, one group leader will be selected from each group and the educational content will be presented to them through the researcher. Then the specified members of each group will form a group of experts together and will review the desired educational topic with their participation and have a comprehensive review of the concepts of the topic and master the components of the topic in the presence of the researcher. The group will return and present the concepts to their group members, and then the researcher will summarize the topics and this process will continue for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nurses' attitude score towards delirium. Timepoint: At the beginning of the study (before the start of the intervention) and four weeks after the intervention. Method of measurement: The instrument of nurses' attitude towards delirium includes 38 items with a 1-5 Likert scale (from completely disagree to completely agree) and has four areas of knowledge, ability and self-confidence, ability to identify and understand the consequences, desire to know more and burden of care. In this questionnaire, the minimum score is 38 and the maximum score is 190.</prim_outcome>
      <prim_outcome>Nursing Delirium Screening Scale. Timepoint: At the beginning of the study (before the start of the intervention) and four weeks after the intervention. Method of measurement: The delirium screening nursing tool have 5 dimensions, including impaired consciousness, inappropriate behavior, inappropriate communication, perceptual sensory error/hallucinations, psychomotor delay, each dimension is scored from 0 to 2 based on the conditions.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Research Ethics Committees of School of Pharmacy and Nursing &amp; Midwifery- Shahid Beheshti University</contact_name>
        <contact_address>hahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Ayatollah Taleghani Hospital - Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
