<?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>IRCT20181101041524N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Supportive Training Program on Depression and Anxiety and Satisfaction of Families of Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of  Supportive Training Program on Depression and Anxiety and Satisfaction of Families of Patients with Acute Coronary Syndrome Admitted to the Cardiac Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37322</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research units according to the sequences  that generated by SPSS software before the start of the study were randomly divided into intervention and control groups. In order to prevent the dissemination of information between the two group,until the patients selected for the first group are not discharged from the ward, sampling for the second group will not take place.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational and supportive program will be implemented, which will include the educational, support and counseling needs of the patient's family in this program.The intervention will be implemented from the patient's Hospitalization day in the CCU ward and will continue for up to 3 days in the cardiology ward.The supportive program includes information support and emotional support.In this way, in the emotional support from the time of admission, the researcher will be with family members and while performing psychological support from them, she describes the patient's condition and listens to their words and she Reassures them about the patient's care and answer questions, concerns and express their feelings and It also considers a scheduled visit to the patient's family; this is the case during the period of admission to the cardiac care unit, after the patient is in a stable position, the patient's companion can meet his patient once a day.Meetings will be scheduled  according to need of companion and patient.The family will be taught to control their feelings and use promising and hopeful words to calm the patient.In support of information the patient family will be informed about the patient's condition and vital signs daily and during this time the researcher will answer the patient's family questions and concerns.In the training program, the CCU ward, equipment, patient connections, the nature of the disease and the treatment process will be explained.These trainings will be face-to-face and educational pamphlets will be given to the family.When treatment is required, a description of the treatment options will be provided about the benefits and complications of each treatment.These trainings take place in a room and in a quiet environment for 40 minutes in coordination with the head nurse to determine the training room.Finally, on the third day of hospitalization in the cardiology ward, post-discharge care, such as proper diet, proper physical activity, and regular use of medications, will be trained for a maximum of 45 minutes plus pamphlets.The number of training sessions during the hospital stay is scheduled according to the need for attendance, in which at least two training sessions are held during these three days of intervention. Intervention 2: Control group: control group will receive the usual care, so that at the beginning of the patient's stay, a welcome pamphlet is given to the family, which includes information on the rules and environment of the ward, telephone number and hours of the visit.Information is also given to the patient's family upon request from the family regarding the patient's condition.At the discharge time, information is provided to the patient about the diet, medications and physical activity, along with educational pamphlets.Routine training in hospitals is general and does not need to be performed based on the needs of the patient's family.There is no advice on the types of treatments and only information about the ACS disease care and cardiac care unit is provided to all patients in the form of a pre-prepared training pamphlet.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Faroujizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,  Ebne Sina Street, University Blvd Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>faroujizadehf951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fateme faroujizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,  Ebne Sina Street, University Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>faroujizadehf951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Including criteria for patient:Diagnosis of acute coronary heart disease by clinical signs, ECG and enzyme tests approved by the cardiologist
Including criteria for patient family:First-class members of the family of patients admitted to the cardiac care unit according to the patient's choice
Primary education
Fluency in Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of hospitalization in ccu ward
Having health care jobs
Having a visual and audio problem
Take care of another person at the same time
Having a history of illness and mental disorders based on the patient's history and self-declaration</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The educational and supportive program will be implemented, which will include the educational, support and counseling needs of the patient's family in this program.The intervention will be implemented from the patient's Hospitalization day in the CCU ward and will continue for up to 3 days in the cardiology ward.The supportive program includes information support and emotional support.In this way, in the emotional support from the time of admission, the researcher will be with family members and while performing psychological support from them, she describes the patient's condition and listens to their words and she Reassures them about the patient's care and answer questions, concerns and express their feelings and It also considers a scheduled visit to the patient's family; this is the case during the period of admission to the cardiac care unit, after the patient is in a stable position, the patient's companion can meet his patient once a day.Meetings will be scheduled  according to need of companion and patient.The family will be taught to control their feelings and use promising and hopeful words to calm the patient.In support of information the patient family will be informed about the patient's condition and vital signs daily and during this time the researcher will answer the patient's family questions and concerns.In the training program, the CCU ward, equipment, patient connections, the nature of the disease and the treatment process will be explained.These trainings will be face-to-face and educational pamphlets will be given to the family.When treatment is required, a description of the treatment options will be provided about the benefits and complications of each treatment.These trainings take place in a room and in a quiet environment for 40 minutes in coordination with the head nurse to determine the training room.Finally, on the third day of hospitalization in the cardiology ward, post-discharge care, such as proper diet, proper physical activity, and regular use of medications, will be trained for a maximum of 45 minutes plus pamphlets.The number of training sessions during the hospital stay is scheduled according to the need for attendance, in which at least two training sessions are held during these three days of intervention.</i_keyword>
      <i_keyword>Control group: control group will receive the usual care, so that at the beginning of the patient's stay, a welcome pamphlet is given to the family, which includes information on the rules and environment of the ward, telephone number and hours of the visit.Information is also given to the patient's family upon request from the family regarding the patient's condition.At the discharge time, information is provided to the patient about the diet, medications and physical activity, along with educational pamphlets.Routine training in hospitals is general and does not need to be performed based on the needs of the patient's family.There is no advice on the types of treatments and only information about the ACS disease care and cardiac care unit is provided to all patients in the form of a pre-prepared training pamphlet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: At the time of admission and 72 hours after admission. Method of measurement: Depression, Anxiety and stress Scales( DASS).</prim_outcome>
      <prim_outcome>The amount of anxiety. Timepoint: At the time of admission and 72 hours after admission. Method of measurement: Depression, Anxiety and stress Scales( DASS).</prim_outcome>
      <prim_outcome>Satisfaction of family members of hospitalized patients. Timepoint: 72 hours after admission. Method of measurement: Family Satisfaction in the Intensive Care Unit FS-ICU (34).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-07</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Opposite University Street 18-University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
