<?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>IRCT20161116030926N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-20</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>"The management of delirium "   &amp;  "Nurse mentoring intervention whit family participation "</public_title>
      <acronym></acronym>
      <scientific_title>Title: The effect of a nurse mentoring intervention whit family participation in the management of delirium in ICU patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Instead of randomizing people, random blocks of time will be used to prevent information interference between groups. Two-week blocks will be allocated to one of the intervention or control groups by lottery method. Thus, if the first time block is allocated to the control group, in this block, patients who have inclusion criteria and according to the criteria If Neecham develops delirium, they will be assigned to a control group with their caregiver, and vice versa. Random time block allocation will continue until the sample size reaches the desired level in each group, Blinding description: To prevent information interference between groups, caregivers will be committed to preventing information exchange until the end of the study, and the sampling and assignment process for each subgroup will be performed after discharge of all patients in the previous block. Random assignment of patients to intervention and control groups will be done by a person who is not involved in the sampling and data collection process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Management of Dlirium.</hc_freetext>
      <i_freetext>Intervention group: Twice in the morning and evening for three days, an outpatient appointment will be made in the presence of the mentor nurse, and the selected family member will sit next to the patient in the presence of the mentor who has experience working in the ICU, holding hands. The patient leaves and talks to him about family issues. During the visit, the patient's delirium-induced behaviors are observed by a family member, and the mentor's nurse explains the adaptation and management of these behaviors to the caregiver..</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 individual data can be shared after being unidentified

When:
6 months after printing the results

To whom:
Researchers working in academic and scientific institutions and patients admitted to the ICU

Conditions:
For use in scientific research and patient education

Where to obtain:
Refer to the website of Urmia University of Medical Sciences, School of Nursing and Midwifery

How to obtain:
Send request to aliluleyla @ gmail .com and about 2 days after receiving the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr leyla--- Alilu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Alley, Resalat Blv,Uromia University Of Medical Science</address>
        <city>Uromia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>aliluleyla@gmail .com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>leyla-Alilu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Alley,Resalat Blv,Uromia University of Medical Sciences</address>
        <city>Uromia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>aliluleyla@gmail .com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient or companions have the physical and cognitive ability to provide informed consent
The patient has no history of cognitive diseases such as dementia
After hospitalization according to Neecham criteria with a score below 25 has delirium and is confirmed by a medical diagnosis
The patient or caregiver is not addicted to alcohol
Be hospitalized until discharge and completion of 6 interventions
A qualified caregiver should be available twice daily for 3 consecutive days after the onset of delirium to visit the patient and participate in the intervention and receive mentoring interventions at the patient's bedside</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to attend the mentoring sessions more than once
Transfer of the patient to another medical center, discharge or death of the patient
Decreased alertness and sedative intake continuously after delirium
No special visitation restrictions due to a specific or transmissible disease
Start sedatives by continuous infusion
Cardiac resuscitation - pulmonary intubation
Severe restlessness that may harm the caregiver and the mentor nurse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Code R41.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ICD-10-CM Diagnosis Code R41.0</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Twice in the morning and evening for three days, an outpatient appointment will be made in the presence of the mentor nurse, and the selected family member will sit next to the patient in the presence of the mentor who has experience working in the ICU, holding hands. The patient leaves and talks to him about family issues. During the visit, the patient's delirium-induced behaviors are observed by a family member, and the mentor's nurse explains the adaptation and management of these behaviors to the caregiver.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Management of delirium in ICU. Timepoint: Before the intervention and twice in the morning at 8 am and 7 pm for three consecutive days. Method of measurement: Richmond Agitation Sedation Scale &amp; Neelon and Champagne (NEECHAM) Confusion Scale&amp;Mini Mental Status Examination.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-24</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Basij Sqr,montazery St,Gamar e Banihashem Hospital Khoy West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
