<?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>IRCT201304027529N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-04</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effect of sound therapy on agitation and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sounds therapy on agitation and anxiety in patients undergoing coronary artery bypass graft during the weaning of mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8012</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: The patients in the experimental group were given nature-based sounds (birds’ song, soothing rain sounds, river stream) through an audiotape via fixed earphones, then 20 min rest. This is done until extubation. The nature sounds were played using a MP3 media player ( Leono Inc., Guangzhou, China) through disposable foam-lined headphones The average sound pressure level was set to 25-50 dB. For all samples is recording anxiety and agitation score. Intervention 2: The patients assigned to the control group were asked to wear the foam-lined headphone and rest in silence for a similar time frame as the intervention group to minimize unpleasant environmental noises or stimuli.</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>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing faculty, 3 No, Rahimzadeh st., Valie Asre st., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 216641859</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed Universit</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nahid  Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing faculty, 3 No, Rahimzadeh st., Valie Asre st., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6641 8592</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patients were aged between 18 and 65 years;  who were under weaning of mechanical ventilation and undergoing coronary artery bypass graft &#13;
Exclusion criteria:drugs and alcohol abuse  , hearing problem. Past heart surgery. mental illness are recognized and recorded in the medical record, Severe hemodynamic impairment (inotrope dependence of postoperative, active drainage and what prevents weaning). emergency surgery or re-operation to be performed for any reason. During the intervention, the use of any cause that requires dose-stat of common protocol tranquilizers and sedative medication is needed.changes ASV mode mechanical ventilation to the other modes. high dependence of the positive inotropics, delayed weaning process, unstable vital signs during weaning</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patients in the experimental group were given nature-based sounds (birds’ song, soothing rain sounds, river stream) through an audiotape via fixed earphones, then 20 min rest. This is done until extubation. The nature sounds were played using a MP3 media player ( Leono Inc., Guangzhou, China) through disposable foam-lined headphones The average sound pressure level was set to 25-50 dB. For all samples is recording anxiety and agitation score</i_keyword>
      <i_keyword>The patients assigned to the control group were asked to wear the foam-lined headphone and rest in silence for a similar time frame as the intervention group to minimize unpleasant environmental noises or stimuli.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Agitation level. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: Richmond Agitation Sedation Scale (RASS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation  ,after 20 min and 30 min after extubation. Method of measurement: Face anxiety scale (FAS).</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: observation of Monitoring.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: observation of Monitoring.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation(sao2). Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: pulse oximeter.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: observation of Monitoring.</sec_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: observation of Monitoring.</sec_outcome>
      <sec_outcome>Rrespiratory Rate. Timepoint: before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation. Method of measurement: observation of Monitoring.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-15</approval_date>
        <contact_name>Shahed University</contact_name>
        <contact_address>Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
