<?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>IRCT20180520039742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Impact of information on anxiety and depression and satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of nurses programmed report to family of  patients admitted to intensive care  units On their anxiety, depression, and  satisfaction of care</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31487</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the inclusion criteria  in the study, the families of hospitalized patients in the intensive care unit were randomly assigned to the intervention group using the spss software (provided reporting + previous routine) or the control group (only providing previous routine measures). In this way, 12 time intervals of a week are included in the software. Randomly  the spss software specifies that each week the families of patients in the hospital are placed in the intervention or control group, Blinding description: Participants in the study were assigned to two groups. In order to prevent the cross effects of the test and control group on each other, sampling was done at different time periods. Blinding was made so that  there would be no communications among the group members. The questionnaires has been specified with code A (intervention group) and with code B (control group). After completing by the units involved , it is collected by the researcher. Later the results  were sent to be analyzed  by an statistical analyst  who had no information about either groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: The level of anxiety. Condition 2: The level of Depression. Condition 3: level of Satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group  after informing patient's physician , the nurse carries out the patient's clinical situation  in plain and written form at the end of the shift (6 shifts) and within 48 hours of the initial admission  to intensive care unit, Then the nurse provide the spokesman with the  information and answer their questions clearly  (maximally 10-15 minutes). Anxiety and depression status and satisfaction of family members (spokespersons) with Hospital anxiety and depression questionnaire and family satisfaction questionnaire are checked in the care unit at the start of admission to the care unit and 48 hours later. Intervention 2: Control group: the patient's families are orally  provided with the information according to the  routine of the ward (in person or after phone calls). The status of anxiety and depression and family satisfaction are checked  (two of the immediate relatives of the patient are asked ) with the Hospital's anxiety and depression questionnaire  of the patients admitted to intensive care unit at the beginning of the entrance to the intensive care unit and and 48 hours later.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Labaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 11.Imam Khomeini -.Imam Khomeini st</address>
        <city>Torbat jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9571944555</zip>
        <telephone>+98 51 5252 9574</telephone>
        <email>labafm941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Labaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctora cross road, Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9573114415</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>labafm941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>They are less than 60 years old.
The cause of the patient's admission is not chronic illness
At least 48 hours have passed since the patient admitted to the ICU
Having a companion for the first 48 hours</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not cooperating with the researcher</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group  after informing patient's physician , the nurse carries out the patient's clinical situation  in plain and written form at the end of the shift (6 shifts) and within 48 hours of the initial admission  to intensive care unit, Then the nurse provide the spokesman with the  information and answer their questions clearly  (maximally 10-15 minutes). Anxiety and depression status and satisfaction of family members (spokespersons) with Hospital anxiety and depression questionnaire and family satisfaction questionnaire are checked in the care unit at the start of admission to the care unit and 48 hours later</i_keyword>
      <i_keyword>Control group: the patient's families are orally  provided with the information according to the  routine of the ward (in person or after phone calls). The status of anxiety and depression and family satisfaction are checked  (two of the immediate relatives of the patient are asked ) with the Hospital's anxiety and depression questionnaire  of the patients admitted to intensive care unit at the beginning of the entrance to the intensive care unit and and 48 hours later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in hospital anxiety and depression scale(hads). Timepoint: At the admission of the patient in the intensive care unit and 48 hours later. Method of measurement: Hospital Anxiety and Depression Scale(hads).</prim_outcome>
      <prim_outcome>Anxiety score in hospital anxiety and depression scale(hads). Timepoint: At the admission of the patient in the intensive care unit and 48 hours later. Method of measurement: Hospital Anxiety and Depression Scale(hads).</prim_outcome>
      <prim_outcome>Satisfaction Score in family Satisfaction- Intensive Care Units(fs-icu). Timepoint: At the admission of the patient in the intensive care unit and 48 hours later. Method of measurement: family Satisfaction Intensive Care Units(fs-icu).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-21</approval_date>
        <contact_name>Regional Ethics Committee in Mashhad University of Medical Sciences</contact_name>
        <contact_address>NO.17 university. Crossroad of the Ph.D. University Street.Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
