<?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>IRCT201503157494N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-25</date_registration>
      <primary_sponsor>Vice Chancellor for research Mazandaran University of Medical Sciences.</primary_sponsor>
      <public_title>The effects of pleasing olfactory images on the atelectasis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of pleasing olfactory images on the atelectasis in patients with cardiac surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Atelectasis.</hc_freetext>
      <i_freetext>Intervention 1: Patients who are allocated in&#13;
experiment group will receive&#13;
planned trainings before surgery.&#13;
Designed cards with pictures of&#13;
rose, banana, apple and lemon&#13;
placed at their disposal and Will&#13;
be asked to look at these&#13;
pictures and Imagine the smell&#13;
of it in their minds and as much&#13;
as possible to do deep sniffing.&#13;
The exercises will be conducted&#13;
for two hours in the morning&#13;
and evening during the first and&#13;
second day after surgery at the&#13;
awakening. Intervention 2: Patients who are allocated in&#13;
control group will receive the&#13;
hospital routine treatment. Any&#13;
intervention is not done before&#13;
surgery for this group of&#13;
patients.</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>Dr Masumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: consent to participate in the study؛ no emergency surgery(coronary artery bypass and heart valves using sternotomy and cardiopulmonary bypass support)؛ aged 18 years and older؛ ejection fraction more than 30 percent؛ having no mental retardation and olfactory impairment؛ negative history of previous heart or lung surgery؛ negative history of previous severe trauma to the head or nose؛ negative history of previous frequent sinus infections؛ Lack of preoperative pulmonary disease(pneumonia, chronic obstructive pulmonary disease, atelectasis, pleural effusion and asthma)؛ BMI less than 40 kg/m2. Patients with systolic blood pressure less than 90 mm Hg despite additional fluids؛ PH arterial less than 7.30؛ arterial carbon dioxide pressure greater than 50 mmHg؛ arterial oxygen saturation less than 80% despite oxygen؛ blood hemoglobin concentration of less than 7 g/dL؛ serum creatinine greater than3.5 mg/dL were not included in the study.&#13;
Exclusion criteria: patients' unwillingness to continue cooperation؛ need for reoperation due to surgery complications؛ incidence of cognitive and neurological disorders after surgery؛ postoperative hemodynamic instability(systolic blood pressure below 80 mm Hg)؛ postoperative bleeding more than 500 ml؛ need for mechanical ventilation for more than 15 hours after surgery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J98.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulmonary collapse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients who are allocated in&#13;
experiment group will receive&#13;
planned trainings before surgery.&#13;
Designed cards with pictures of&#13;
rose, banana, apple and lemon&#13;
placed at their disposal and Will&#13;
be asked to look at these&#13;
pictures and Imagine the smell&#13;
of it in their minds and as much&#13;
as possible to do deep sniffing.&#13;
The exercises will be conducted&#13;
for two hours in the morning&#13;
and evening during the first and&#13;
second day after surgery at the&#13;
awakening</i_keyword>
      <i_keyword>Patients who are allocated in&#13;
control group will receive the&#13;
hospital routine treatment. Any&#13;
intervention is not done before&#13;
surgery for this group of&#13;
patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Atelectasis. Timepoint: Pre &amp; post operation and second day post operatively. Method of measurement: Chest x ray.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial blood gases. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Arterial blood gas test(ABG).</sec_outcome>
      <sec_outcome>Systolic and diastolic arterial blood pressure. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Tempereture. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Oral Thermometer.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Number of respiratory rate.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Cardiac monitoring.</sec_outcome>
      <sec_outcome>Saturation of Peripheral Oxygen. Timepoint: Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention. Method of measurement: Monitor and pulse oximetry.</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>Vice Chancellor for research Mazandaran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-03</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran. Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
