<?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>IRCT201411304443N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>music therapy and mechanical ventilation</public_title>
      <acronym>music and ventilation</acronym>
      <scientific_title>Effect of  Music therapy  on ventilation criteria  of  patients undergoing  mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patients undergoing  mechanical ventilation.</hc_freetext>
      <i_freetext>Intervention 1: In control group, the headphone was also used to prevent the annoying noises and patients were evaluated twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM. Restrictions imposed were same as intervention group. As the intervention group, all reparatory parameters and other variables were also measured in control group. Intervention 2: In intervention group, instrumental music was played by headphone twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM.  The music used in the study was track 1 of Arnd Stein's masterwork, namely Peace in Dream. This track is about 30 minutes. We chose the evening and morning to intervention, because of minimal medical interventions in these times. The researcher was present during the intervention. The respiratory parameters were recorded from the monitor at specified times. And during the study in intervention group, other nonemergency nursing interventions were stopped. The time for recording the respiratory parameters was defined as follows: before using the headphone and playing the music as 0, 10 minutes after playing music as 10, 20 minutes after playing music as 20, 30 minutes after playing music as 30; and all parameters were recorded from monitor of ventilator.</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>masoome zakeri moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University Of medical Science, School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61054343</telephone>
        <email>mzakerimo@gmail,com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>masoome zakeri moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University Of medical Science, School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>iran</zip>
        <telephone>+98 61054343</telephone>
        <email>mzakerimo@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Age above 18 and under 70 years, under respiratory support with ventilator and with modes of CPAP, PSV, SIMV, maximum number of mandatory breathing apparatus Was 10, Tracheal intubation or Tracheostomy, staying under mechanical ventilation for more than 24 hours, the Glasgow score above 7, the acute physiology score or APACHE II less than 20, no hearing problems, Hemodynamically stable condition including heart rate under 130 beats per minutes and systolic blood pressure above 90 mm Hg.&#13;
Exclusion criteria:&#13;
Having COPD and ARDS, discharge; sever hemodynamic impairment, the patient's unwillingness to participate in the study, the death of patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j95.0 , j9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic respiratory failure, Acute respiratory failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group, the headphone was also used to prevent the annoying noises and patients were evaluated twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM. Restrictions imposed were same as intervention group. As the intervention group, all reparatory parameters and other variables were also measured in control group.</i_keyword>
      <i_keyword>In intervention group, instrumental music was played by headphone twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM.  The music used in the study was track 1 of Arnd Stein's masterwork, namely Peace in Dream. This track is about 30 minutes. We chose the evening and morning to intervention, because of minimal medical interventions in these times. The researcher was present during the intervention. The respiratory parameters were recorded from the monitor at specified times. And during the study in intervention group, other nonemergency nursing interventions were stopped. The time for recording the respiratory parameters was defined as follows: before using the headphone and playing the music as 0, 10 minutes after playing music as 10, 20 minutes after playing music as 20, 30 minutes after playing music as 30; and all parameters were recorded from monitor of ventilator.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Peak airway presser. Timepoint: 30 minutes in morning and 30 minutes in evening. Method of measurement: Seen from the ventilator monitor and recorded in H2O cm.</prim_outcome>
      <prim_outcome>Tidal volume. Timepoint: 30 minutes in morning and 30 minutes in evening. Method of measurement: Seen from the ventilator monitor and recorded in ml.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 30 minutes in morning and 30 minutes in evening. Method of measurement: Seen from the ventilator monitor and recorded in terms of the number per minute.</prim_outcome>
      <prim_outcome>Minute  ventilation. Timepoint: 30 minutes in morning and 30 minutes in evening. Method of measurement: Seen from the ventilator monitor and recorded in ml.</prim_outcome>
      <prim_outcome>Spo2. Timepoint: 30 minutes in morning and 30 minutes in evening. Method of measurement: From pulse oximeter monitor in percentile.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Respiratori rate- spo2-peak airway presser-tv-mv. Timepoint: Time zero and ten and twenty and thirty minutes after the start of Music Therapy. Method of measurement: by using ventilator monitorig.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-18</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Office building of Tehran University of medical Science, Keshavarz St, Tehran. tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
