<?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>IRCT2013110415280N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-11</date_registration>
      <primary_sponsor>Yazd SHahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>the effect of family members voice  on level of consciousness of comatose  patients</public_title>
      <acronym></acronym>
      <scientific_title>Survey of the effect of family members voice  on level of consciousness of comatose  patients admitted to the Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coma.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receive a 10- day, twice daily in the morning and night shifts for 15-5 min tape -recorded voice of a loved one patient in the patient 's family ( with the patient's family ) known content ( patient notification to person, time, place , brief events that occurred in , repeating the name of the patient at least three times during the recording, expressing fond memories and termination bar with Statement of expressions of patients to return to his family) by MP3 Player and by placing the headphones on his ears and auditory stimulation is and Before and after each auditory stimulation ( four times daily ) Glasgow Coma Scale score will be determined by the research assistant during any intervention by the research assistant refused to touch the patient. It 's the sound of a loved one in the family by MP3 Player device model Marshal will be recorded by the investigator in a separate room in the hospital. Intervention 2: In the control group without stimulation with sound family intervention group with the same time intervals ( four times daily ) Glasgow Coma Scale score of patients is measured.</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>Manijeh SHahriary Kalantary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Building No.2, Bahonar Square, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1824 1755</telephone>
        <email>m_kalan13@ssu.ac.ir</email>
        <affiliation>Yazd SHahid Sadoughi University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Tavangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Buali street, Safaieh,  Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+351 8241755</telephone>
        <email>tavangar@ssu.ac.irtavangar11@yahoo.com</email>
        <affiliation>Yazd SHahid Sadoughi  School of Nursing - Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : patients with of 75-15 years; of both sexes; with GCS less than or equal to 8 at least 24 hours after symptoms have hemodynamic stabilization.&#13;
 Exclusion criteria : a history of head injury and impairment or hearing loss; bleeding from the ear or nose; Skull base fractures; as a history of drug abuse.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>s06.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Traumatic Subdural Haemorrhage</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receive a 10- day, twice daily in the morning and night shifts for 15-5 min tape -recorded voice of a loved one patient in the patient 's family ( with the patient's family ) known content ( patient notification to person, time, place , brief events that occurred in , repeating the name of the patient at least three times during the recording, expressing fond memories and termination bar with Statement of expressions of patients to return to his family) by MP3 Player and by placing the headphones on his ears and auditory stimulation is and Before and after each auditory stimulation ( four times daily ) Glasgow Coma Scale score will be determined by the research assistant during any intervention by the research assistant refused to touch the patient. It 's the sound of a loved one in the family by MP3 Player device model Marshal will be recorded by the investigator in a separate room in the hospital.</i_keyword>
      <i_keyword>In the control group without stimulation with sound family intervention group with the same time intervals ( four times daily ) Glasgow Coma Scale score of patients is measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Consciousness. Timepoint: Before and after the intervention. Method of measurement: Glasgow Coma Scale.</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>Yazd SHahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-21</approval_date>
        <contact_name>Yazd SHahid Sadoughi University Of Medical Sciences</contact_name>
        <contact_address>Building No. 2, Bahonar Square, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
