<?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>IRCT2017092532764N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-05</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahrekord University of Medical Sciences and Health Service</primary_sponsor>
      <public_title>The effect of positive psychology-based audio messages on patients with acute coronary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of positive psychology-based audio messages on psychological variables in patients with acute coronary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25443</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>Condition 1: acute coronary syndrome. Condition 2: acute coronary syndrome. Condition 3: acute coronary syndrome. Condition 4: acute coronary syndrome. Condition 5: acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: they will receive audio file of positive psychological messages with topics of morning optimism, short term and temporal hospitalization, positive perception of CCU hospitalization event, external and non-permanent view of hospitalization process, hope for alleviation and its effect, positive imaging of the future in the field of heart health, meditation focused on positive imaging of the heart and blood vessels, optimistic appreciation of the severity of symptoms of my heart disease, controllability of my heart disease, optimistic appreciation during sleep, and cardiac self-care through the headphones four times a day for three-day hospitalization. And for six weeks at home, they will receive twice a week the optimistic psychological messages with topics of positive interpretation of the damage and heart disease, post-traumatic development, optimistic appreciation of the symptom severity of my heart disease, hope for the future, controllability of my heart disease, readiness to cope with the crisis -for the worst possible condition, positive mindfulness and self-talk, optimism for social support, short-term and temporal acute period of illness, morning optimism when awakening, good appreciation  at bedtime, transform optimism into a habit and cardiac self-care through headphone. Intervention 2: Control group: They will receive audio file of self-care messages with the topics related to getting acquainted with the cardiac care unit, the cardiovascular system, the risk factors of coronary artery disease, angina pectoris, heart attack, and hospital treatments through headphones two times a day for three-day hospitalization. Then for six weeks at home, they will receive messages with the topics related to the examination and control of disease symptoms, the adoption of a treatment regimen, the maintenance of healthy lifestyle, controlling the impact of the disease on the daily performance by voice and with Headphones twice a week.</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>Sara Hadadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of a Medical Sciences and Health Service , Kashani street, Shahrekord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 381330061</telephone>
        <email>sarahadad1363@gmail.com</email>
        <affiliation>Shahrekord University of Medical Sciences and Health Service</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Abolhassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 3333 0061</telephone>
        <email>Sh_abolhassani@yahoo.com</email>
        <affiliation>Shahrekord University of Medical Sciences and Health Service</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: confirmation of Acute Coronary Syndrome by Cardiologist; no history of hospitalization in the cardiac care unit; willingness to participate in the study; ability to understand conversation in Persian language; age of 30 to 75 years; no use of psychological treatment;  having no hearing problems&#13;
Exclusion criteria: failure to co-operate with the patient; patient's death during the study; complications of life threatening complications</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>120</hc_code>
      <hc_code>121</hc_code>
      <hc_code>122</hc_code>
      <hc_code>123</hc_code>
      <hc_code>124</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Angina pectoris</hc_keyword>
      <hc_keyword>acute myocardial infarction</hc_keyword>
      <hc_keyword>Subsequent myocardial infarction</hc_keyword>
      <hc_keyword>Certain current complications following acute myocardial infarction</hc_keyword>
      <hc_keyword>Other acute ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: they will receive audio file of positive psychological messages with topics of morning optimism, short term and temporal hospitalization, positive perception of CCU hospitalization event, external and non-permanent view of hospitalization process, hope for alleviation and its effect, positive imaging of the future in the field of heart health, meditation focused on positive imaging of the heart and blood vessels, optimistic appreciation of the severity of symptoms of my heart disease, controllability of my heart disease, optimistic appreciation during sleep, and cardiac self-care through the headphones four times a day for three-day hospitalization. And for six weeks at home, they will receive twice a week the optimistic psychological messages with topics of positive interpretation of the damage and heart disease, post-traumatic development, optimistic appreciation of the symptom severity of my heart disease, hope for the future, controllability of my heart disease, readiness to cope with the crisis -for the worst possible condition, positive mindfulness and self-talk, optimism for social support, short-term and temporal acute period of illness, morning optimism when awakening, good appreciation  at bedtime, transform optimism into a habit and cardiac self-care through headphone.</i_keyword>
      <i_keyword>Control group: They will receive audio file of self-care messages with the topics related to getting acquainted with the cardiac care unit, the cardiovascular system, the risk factors of coronary artery disease, angina pectoris, heart attack, and hospital treatments through headphones two times a day for three-day hospitalization. Then for six weeks at home, they will receive messages with the topics related to the examination and control of disease symptoms, the adoption of a treatment regimen, the maintenance of healthy lifestyle, controlling the impact of the disease on the daily performance by voice and with Headphones twice a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention. Method of measurement: Hospital Anxiety And Depression Scale.</prim_outcome>
      <prim_outcome>Depression. Timepoint: before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention. Method of measurement: Hospital Anxiety And Depression Scale.</prim_outcome>
      <prim_outcome>Hope. Timepoint: before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention. Method of measurement: Hope Questionary.</prim_outcome>
      <prim_outcome>Optimism. Timepoint: before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention. Method of measurement: Life Orientation Test-Reviseved.</prim_outcome>
      <prim_outcome>Positive affect. Timepoint: before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention. Method of measurement: Positive and Negative Affect Scale (PANAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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, Shahrekord University of Medical Sciences and Health Service</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-13</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences and Health Service</contact_name>
        <contact_address>Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
