<?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>IRCT2015122019919N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences (Primary Sponsor)</primary_sponsor>
      <public_title>Comparison between the effect of music therapy and aromatherapy in sleep quality and physiological indices in myocardial infarection patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effect of music therapy and aromatherapy in sleep quality and physiological indices in myocardial infarection patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myocard  infarction.</hc_freetext>
      <i_freetext>Intervention 1: In the  music therapy in patients for three consecutive nights, music of your choice that evening, the first day of the intervention of the music list which is approved by the Ministry of Islamic GuidanceThe hearing through headphones, choose and one hour before sleep for 30 to 45 minutes via the hands-free type Sony will hear in your bed And physiological index patients one hour before and one hour after 6 am after music therapy and the use of monitoring devices measuring and marking Alborz 7b  in the chart will be provided in the table, the process is carried out for three consecutive nights will be The patient's sleep quality using the Pittsburgh Sleep Quality Index intervention once before and again after the third night will be completed by the patients. Intervention 2: In the control group with no intervention will be done by the researcher, only routine interventions and treatments that can be performed for all patients receive. Intervention 3: Patients in the aromatherapy group for three consecutive nights, each night an hour before sleep four drops of essential oil on a cotton ball spilled pure lavender After two minutes inhaling from a distance of two inches of the pin nose up at 6 am to Dickey  install and notes of treated patients, cotton balls at six of Dickey patients will be isolated.</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>Suri Jafarlu Vahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz- South Shariati Street - School of Sursing and Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56941-68451</zip>
        <telephone>+98 452721690</telephone>
        <email>sori1991vahid@yahoo.com</email>
        <affiliation>Tabriz University of Medical scinces - School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arefe Davoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariati Street -School of Nursing and Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34770648</telephone>
        <email>arefehdavoodi@gmail.com</email>
        <affiliation>Tabriz University of Medical Scinces - School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: Would like to participate in the study and signed an informed consent form؛ male and female patients aged 30 to 75 years who are hospitalized in the intensive care unit with a diagnosis of myocardial infarction؛ complete consciousness and awareness of time, place or person؛ Auditory and olfactory disorder, according to the patient and not be a member of the immediate family؛ History of eczema, hives or respiratory problems such as allergies to flowers and plants and not name؛ Any serious mental disorder, according to the patient or is not a member of the immediate family؛ scores from the initial assessment questionnaire Pittsburgh Sleep Quality Index is equal to or less than 5.&#13;
Exclusion criteria: Avoid proceeding at any stage of intervention؛ drug addiction (according to the patient or a family member)؛ employment health</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the  music therapy in patients for three consecutive nights, music of your choice that evening, the first day of the intervention of the music list which is approved by the Ministry of Islamic GuidanceThe hearing through headphones, choose and one hour before sleep for 30 to 45 minutes via the hands-free type Sony will hear in your bed And physiological index patients one hour before and one hour after 6 am after music therapy and the use of monitoring devices measuring and marking Alborz 7b  in the chart will be provided in the table, the process is carried out for three consecutive nights will be The patient's sleep quality using the Pittsburgh Sleep Quality Index intervention once before and again after the third night will be completed by the patients.</i_keyword>
      <i_keyword>In the control group with no intervention will be done by the researcher, only routine interventions and treatments that can be performed for all patients receive.</i_keyword>
      <i_keyword>Patients in the aromatherapy group for three consecutive nights, each night an hour before sleep four drops of essential oil on a cotton ball spilled pure lavender After two minutes inhaling from a distance of two inches of the pin nose up at 6 am to Dickey  install and notes of treated patients, cotton balls at six of Dickey patients will be isolated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve the quality of life and mean arterial presure. Timepoint: Sleep quality: on the first evening and the morning were the fourth day Inclusion. Method of measurement: Pittsburgh Sleep Quality Index.</prim_outcome>
      <prim_outcome>Mean arterial presure. Timepoint: One hour before and one hour after 6 am after the intervention and intervention for three consecutive nights. Method of measurement: Using calibrated monitoring devices available in the cardiac care unit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improve the physiological (arterial systolic and diastolic blood pressure), body temperature, arterial oxyhemoglobin saturation, heart rate and respiration disease. Timepoint: One hour before and one hour after the experimental intervention and at 6 am after a period of three consecutive nights. Method of measurement: Using standard monitoring devices available in the tympanic thermometer devices.</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>Tabriz University of Medical Sciences (Primary Sponsor)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-02</approval_date>
        <contact_name>Tabriz medical sciences</contact_name>
        <contact_address>tabriz university of scinces - university street -= univrsity gate- tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
