<?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>IRCT2014081418794N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-23</date_registration>
      <primary_sponsor>Medical Sciences Vice Chancellor for Research, Zanjan University of Medical Science</primary_sponsor>
      <public_title>Auditory stimulation in comatose patients</public_title>
      <acronym></acronym>
      <scientific_title>Auditory stimulation by family voices and recitation of prayers on consciousness level and hemodynamic changes of comatose patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16936</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Traumatic Brain Injury.</hc_freetext>
      <i_freetext>Intervention 1: Patient familiar voice was recorded with mp3 by Mark Marshall. This sound contains was introduction to a patient, slight accident occurred and reassuring messages. Sounds were delivered through headphones to listen to the patient. Before using for the patient controlled louder volume by researcher to patient does not hurt. Sound familiar  twice a day for two weeks, in time for afternoon prayer and the  sunset in the patients was born into  group.Sounds duration of about 3 to 5 minutes. Before and after intervention in  group  consciousness level and hemodynamic variables were recorded. Intervention 2: The sound of the call to prayer of the muezzin's voice was born. The call duration is approximately 4 minutes that 14 days this sound like a familiar voice, twice daily at noon and evening prayer for the patient by headphone. Before and after the intervention of consciousness and hemodynamic variables were recorded. Intervention 3: The control group did not receive any intervention by the researcher.It's just routine hearing voices.In this group, twice daily for 14 days,  Level of consciousness and hemodynamics were recorded.</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>Fatemeh Mogadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences,  Beginning of the Islamic Republic of Iran, Azadi Square, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3575 3185</telephone>
        <email>Fateme.mogadam@gmail.com;  payami@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Payami Busari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Parvin Etesami S,  Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3377 0909</telephone>
        <email>Fateme.mogadam124@gmail.com; payami@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for this study included:&#13;
 Comatose traumatic patients; Muslim patients; Ages range from 68-14 years; Levels of consciousness 8 and less than 8; No fracture and surgery for temporal lobe; The lack of swelling of both eyelids; Absence of severe mental illness; Absence of Fracture four limbs; Family consent for participation in the study; The absence of hearing loss. &#13;
Exclusion criteria included:&#13;
patient died before day 14 in both groups; Swelling of both eyelids; Changes in the patient's condition so that the possibility of intervention , such as sending a patient away to another hospital, cardiac arrest.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>68 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>SO6.0, SO6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intracranial injury</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patient familiar voice was recorded with mp3 by Mark Marshall. This sound contains was introduction to a patient, slight accident occurred and reassuring messages. Sounds were delivered through headphones to listen to the patient. Before using for the patient controlled louder volume by researcher to patient does not hurt. Sound familiar  twice a day for two weeks, in time for afternoon prayer and the  sunset in the patients was born into  group.Sounds duration of about 3 to 5 minutes. Before and after intervention in  group  consciousness level and hemodynamic variables were recorded.</i_keyword>
      <i_keyword>The sound of the call to prayer of the muezzin's voice was born. The call duration is approximately 4 minutes that 14 days this sound like a familiar voice, twice daily at noon and evening prayer for the patient by headphone. Before and after the intervention of consciousness and hemodynamic variables were recorded.</i_keyword>
      <i_keyword>The control group did not receive any intervention by the researcher.It's just routine hearing voices.In this group, twice daily for 14 days,  Level of consciousness and hemodynamics were recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Consciousness. Timepoint: pre and post intervention. Method of measurement: GCS Scale.</prim_outcome>
      <prim_outcome>Hemodynamic Status. Timepoint: pre and post  intervention. Method of measurement: Monitoring sistem and Termometer.</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>Medical Sciences Vice Chancellor for Research, Zanjan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-17</approval_date>
        <contact_name>Ethics Committee, Zanjan University of Medical Science</contact_name>
        <contact_address>Zanjan University of Medical Sciences,  Beginning of the Islamic Republic of Iran, Azadi Square, Zanjan Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
