<?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>IRCT20231224060510N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-15</date_registration>
      <primary_sponsor>The Khomein Faculty of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the impact of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the impact of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done based on the table of random numbers. In this way, in the beginning, all the research units were numbered, then the RandBetween function was used by Excel software, and between the numbers 1 and 75 random numbers were obtained, and then the first 25 random numbers in the first study group, the second 25 random numbers. In the second study group and 25 random numbers in the third are placed in the control group, Blinding description: The research units are unaware of the type of intervention in other groups.
The data analyst also has access to the raw data.</study_design>
      <phase>3</phase>
      <hc_freetext>Myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Nursing care for 2 months based on the specific situational model. In this group, after completing the quality of life questionnaire, first a preliminary meeting is held and educational materials are presented and a notebook containing the information needed by the patient is given to him in simple language. There is also a table in this notebook where weekly information such as blood pressure, weight and edema are recorded. At the end of 2 months, the quality of life questionnaire is completed again. Intervention 2: Nursing care for 2 months based on Orem's nursing care model. In this group, after completing the quality of life questionnaire, 3 sessions will be held in the cardiac special care unit. 24 hours after admission, 72 hours after admission and before discharge from the ward. In the first session, introduction and communication with the patient is done and a special educational pamphlet is presented to them. In the second session, training is given on the disease, symptoms and treatment, and in the third session, summary and discharge training is given. The condition of the patient is followed up every week for 2 months and the necessary training is given. After 2 months, the quality of life questionnaire will be completed again. Intervention 3: The patients of the control group are under the usual care of the department. Actions include daily visits, giving prescribed medicines based on the physician's order, vital signs control, cardiac rhythm control, regular education about drugs, diet, exercise, follow-up of tests and referrals.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Research results

When:
The end of the research

To whom:
- Researchers working in academic institutions
- Employees in the nursing profession

Conditions:
All actions that are not contrary to ethics in research can be done

Where to obtain:
The request should be sent to hamid52us@yahoo.com.

How to obtain:
The request should be sent to hamid52us@yahoo.com.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Quds Blvd, Khomein, Iran</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881858573</zip>
        <telephone>+98 86 4622 1536</telephone>
        <email>hamid52us@yahoo.com</email>
        <affiliation>The Khomein Faculty of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Quds Blvd, khomein, Iran</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38818558573</zip>
        <telephone>+98 86 4622 1536</telephone>
        <email>hamid52us@yahoo.com</email>
        <affiliation>The Khomein Faculty of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a heart attack according to the physician's diagnosis and entered in the patient's file
Not sufferer from cancer
No mental disorders
Consent to participate in the research by filling out Informed consent form
A resident of Khomein city</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of hospitalization in cardiac care unit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Nursing care for 2 months based on the specific situational model. In this group, after completing the quality of life questionnaire, first a preliminary meeting is held and educational materials are presented and a notebook containing the information needed by the patient is given to him in simple language. There is also a table in this notebook where weekly information such as blood pressure, weight and edema are recorded. At the end of 2 months, the quality of life questionnaire is completed again.</i_keyword>
      <i_keyword>Nursing care for 2 months based on Orem's nursing care model. In this group, after completing the quality of life questionnaire, 3 sessions will be held in the cardiac special care unit. 24 hours after admission, 72 hours after admission and before discharge from the ward. In the first session, introduction and communication with the patient is done and a special educational pamphlet is presented to them. In the second session, training is given on the disease, symptoms and treatment, and in the third session, summary and discharge training is given. The condition of the patient is followed up every week for 2 months and the necessary training is given. After 2 months, the quality of life questionnaire will be completed again.</i_keyword>
      <i_keyword>The patients of the control group are under the usual care of the department. Actions include daily visits, giving prescribed medicines based on the physician's order, vital signs control, cardiac rhythm control, regular education about drugs, diet, exercise, follow-up of tests and referrals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Quality of life is measured at the beginning of the intervention and 2 months after the intervention. Method of measurement: Quality of life questionnaire SF-36.</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>The Khomein Faculty of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-12</approval_date>
        <contact_name>Ethics committee of Khomein Faculty of Medical Sciences</contact_name>
        <contact_address>Khomein Faculty of Medical Sciences, Quds Blvd. Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
