<?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>IRCT201012145392N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-16</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences. nursing midwfery college</primary_sponsor>
      <public_title>Music therapy in patients with head injuries</public_title>
      <acronym></acronym>
      <scientific_title>Effects of calm music on physiological indexes ( Oxygen saturation,heart rate,respiratory rate, systolic, diastolic blood pressure,main arterial pressure, Pulse pressure and central tempreture) of patients with traumatic brain injuries in intensive care units of shahid beheshti medical university hospitals in 2011</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>head Injuries.</hc_freetext>
      <i_freetext>Light Music : The patient will listen to light music for sequence of 3 days at 16 to 18 oclock for 15 minutes each session through headphone..</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>Marzieh Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing midwfery college, crossroads valieaser with niaiesh,valieaser St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>mmaleki@sbmu.ac.ir,mmaleki5@yahoo.com</email>
        <affiliation>Nursing midwifery college,Shaheed Beheshti Medical Sciences university.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing midwfery college, crossroads valieaser with niaiesh,valieaser St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>mmaleki5@yahoo.com, mmaleki@sbmu.ac.ir</email>
        <affiliation>Shaheed Beheshti nursing midwifery Coleage</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: presence of traumatic brain injuries at intensive care units (ICU), GCS between 8 to 10, stable hemodynamic situation (e.g. fluid and electrolytes), no any auditory defects, not receiving continues IV sedative drugs, age 18 to 49 years old, no admission more than one month&#13;
Exclusion criteria: imbalance hemodynamic or death, GCS decreased to less than 8 or increased more than 10 during the intervention phase</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>63 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injures to head</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Light Music : The patient will listen to light music for sequence of 3 days at 16 to 18 oclock for 15 minutes each session through headphone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Observation the chest movements( up and down movements) in rate per minute.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Radial pulse palpation, in rate per minute.</prim_outcome>
      <prim_outcome>Pripheral artrial oxygen saturetion(SPO2). Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: pulse oxymeter in percent.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Sphyngomanometer in mmhg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Sphyngomanometer in mmhg.</prim_outcome>
      <prim_outcome>Central body tempreture. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Tympanic thermometer in centigrad degree.</prim_outcome>
      <prim_outcome>Mean Arterial Pressure. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Physiological Parameters form.</prim_outcome>
      <prim_outcome>Pulse pressure. Timepoint: 5 minute before music lisening, at the end of music lisening And 10 minute after that. Method of measurement: Physiological Parameters form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of consciousness. Timepoint: befor and after music lisening. Method of measurement: Glassgow Coma Scale (GCS).</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>Shahid Beheshti University of Medical Sciences. nursing midwfery college</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-02</approval_date>
        <contact_name>Shaheed Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shaheed Beheshti University of Medical Sciences, beside the Taleqani hospital, Yaman St, Shaheed Chamran highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
