<?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>IRCT20210303050566N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>intervention based on Patient Expectation under Coronary Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Intervention Based on Patient Expectations on Coronary Surgery Outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will initially be according to available sampling. This means that patients who meet the inclusion criteria will be included in the study. Patients are then divided into two groups of control and intervention based on random allocation of four blocks. For this purpose, four blocks are selected, so that the intervention group will have the letter A and the control group will have the letter B; The six possible states are written on separate cards and each card will be assigned a number from one to six, then the numbers will be written on paper and removed randomly. Until the expected number of samples is completed. In this study, the online randomization service (http // www.sealedenvelope.com / simple-randomiser / v1 / lists) will be used to block block randomization.Concealment of random allocation will be done using packets in the package. In this way, one of the letters is placed inside each envelope in the specified order, after which the envelope lid will be closed and will be given to the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dementia/ Alzheimer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Between one to week before surgery with patient in this research were contacted using telephone interview questionnaires Patient expectations will be completed by the researcher.Expectation questionnaire The patient will be analyzed and the necessary points to perform the intervention (intervention will be determined based on expectation and optimization of these expectation .After determining the points for intervention, before hospital admission at least tow sessions will be held with patients.It is noteworthy that to perform interventions was coordinated with a cardiologist and a psychiatrist Ahvaz Golestan Hospital then will be scheduled. In the expectations_based intervention outcomes The researcher provides information about surgery and benefits of surgery (The purpose is give information only is not patient education ).The aims of these information to cultivate realistic expectation of treatment and will not be very optimistic . then asked each patient to state their individual expectation of treatment as well as their activity plan after surgery.An example of this activity plan could be this which of the following activities can be used during the recovery process enjoy. And even asked about these activities have illustration and imagination. For positive impact on expectations individual control , to patient about possible symptoms after surgery they have information given. For example , gag reflexes due to the respiratory tract. Researcher and patient share ideas and they will develop programs for adapt to these symptoms. Also talk to patient about what change in health behaviors to help them accelerate recovery . Thus, the expectations of patient individual control are also will be strengthened . After discharge from hospital also during phone call to patient or through WhatsApp the content of specific intervention will be reminded . Intervention 2: Control group: The control group will receive only ordinary ward intervention, which includes explanations of nurse and doctors about heart surgery and care after discharge of hospital.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is NO</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Norouzilarki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4325</telephone>
        <email>katinorouzi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Sayadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4322</telephone>
        <email>l-sayadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years old
Coronary artery surgery for the first time
Fluency in Persian
Elective surgery
Satisfaction to participate in the study
No serious underlying disease and mental illness ( respiratory and renal failure and dialysis)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Member of treatment staff
Family members is a meddical staff</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer's 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: Between one to week before surgery with patient in this research were contacted using telephone interview questionnaires Patient expectations will be completed by the researcher.Expectation questionnaire The patient will be analyzed and the necessary points to perform the intervention (intervention will be determined based on expectation and optimization of these expectation .After determining the points for intervention, before hospital admission at least tow sessions will be held with patients.It is noteworthy that to perform interventions was coordinated with a cardiologist and a psychiatrist Ahvaz Golestan Hospital then will be scheduled. In the expectations_based intervention outcomes The researcher provides information about surgery and benefits of surgery (The purpose is give information only is not patient education ).The aims of these information to cultivate realistic expectation of treatment and will not be very optimistic . then asked each patient to state their individual expectation of treatment as well as their activity plan after surgery.An example of this activity plan could be this which of the following activities can be used during the recovery process enjoy. And even asked about these activities have illustration and imagination. For positive impact on expectations individual control , to patient about possible symptoms after surgery they have information given. For example , gag reflexes due to the respiratory tract. Researcher and patient share ideas and they will develop programs for adapt to these symptoms. Also talk to patient about what change in health behaviors to help them accelerate recovery . Thus, the expectations of patient individual control are also will be strengthened . After discharge from hospital also during phone call to patient or through WhatsApp the content of specific intervention will be reminded .</i_keyword>
      <i_keyword>Control group: The control group will receive only ordinary ward intervention, which includes explanations of nurse and doctors about heart surgery and care after discharge of hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients Expectation. Timepoint: Before intervention, 1 and 3 months after coronary surgery. Method of measurement: Patient expectation questionnaire.</prim_outcome>
      <prim_outcome>Cardiac Anxiety. Timepoint: Before intervention, 1 and 3 months after coronary surgery. Method of measurement: Cardiac Anxiety Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Disability. Timepoint: Before intervention, 1 and 3 months after coronary surgery. Method of measurement: The Pain Disability Questionnaire.</sec_outcome>
      <sec_outcome>Length of Hospital Stay. Timepoint: After Discharge from hospital. Method of measurement: Based on day.</sec_outcome>
      <sec_outcome>Readmission. Timepoint: until 3 month after surgery. Method of measurement: Noted number of readmission during 3 month after surgery.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-20</approval_date>
        <contact_name>Institutional research ethics committee of Nursing, Midwifery &amp; Rehabilitation school</contact_name>
        <contact_address>School of Nursing and Midwifery,Tehran University of Medical Sciences, Nosrat street. Tohid sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
