<?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>IRCT201503048069N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-01</date_registration>
      <primary_sponsor>Vice chancellor for research, University of Tarbiat Modares</primary_sponsor>
      <public_title>Evaluating of the family participation based on affective simulations on improving the level of consciousness patients with brain trauma hospitalized in ICUs: A combined embedded study.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the family participation based on affective stimulations on improving the level of consciousness patients with brain trauma.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Head trauma.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group, family participation through Regular visits and establishing defined communications with the patient as sensory and affective simulations are done by a close member of the family twice a day (morning and evening) for 7 days. : Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale. Intervention 2: In placebo group, visit and sensory simulations are made by an unfamiliar trained person who has no affinity, affective and family relations with the patients twice a day (morning and evening). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale. Intervention 3: In control group, care and visit would be made as is routine in ICUs (the family visit from behind the window and from the distant). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansoreh Movahedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Tarbiat Modares, Nasr Bridge, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 4502</telephone>
        <email>movahed.m@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Esa Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Nasr Bridge,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 3585</telephone>
        <email>mohamade@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Family inclusion criteria:&#13;
He/She can be considered as the first degree relative of the patient (father, mother, sister, brother, child, wife/husband) , having the ability of verbal communication with the others, the age of relative would be in the range of 18 and lower than 65 years old.&#13;
Patients' inclusion criteria:&#13;
Hospitalizing with Head injury (brain trauma) diagnosis, the level of consciousness based on Glasgow Coma Scale between 5 -8, the age of patient between 18-65 years old.&#13;
Exclusion criteria:&#13;
The death of patient during the study, transferring of patient to the other centers during the study, operating a surgery during the study, withdrawing the patient's family to continue to participate in the study, discharge of patient from the unit before 7 days of hospitalization time, having background diseases such as Alzheimer, Parkinson, brain stroke and so on.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-S09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injuries to the head</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group, family participation through Regular visits and establishing defined communications with the patient as sensory and affective simulations are done by a close member of the family twice a day (morning and evening) for 7 days. : Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.</i_keyword>
      <i_keyword>In placebo group, visit and sensory simulations are made by an unfamiliar trained person who has no affinity, affective and family relations with the patients twice a day (morning and evening). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.</i_keyword>
      <i_keyword>In control group, care and visit would be made as is routine in ICUs (the family visit from behind the window and from the distant). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of consciousness. Timepoint: Twice a day,before and immediately after the intervention. Method of measurement: By Glasgow Coma Scale and Coma Recovery Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of stay in the intensive care unit. Timepoint: Once, when discharged from ICU. Method of measurement: By Level of Consciousness Questionnaire.</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>Vice chancellor for research, University of Tarbiat Modares</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-28</approval_date>
        <contact_name>Ethics committee of Medical of Science of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Nasr Bridge, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
