<?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>IRCT20200802048268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  self -care program on quality of life in patients with unstable ungina</public_title>
      <acronym></acronym>
      <scientific_title>Effect of appling of self -care program on  quality of life in patients with unstable ungina</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50046</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling was performed by non-probability sequential method. Samples were allocated to two groups of intervention and control by block random allocation method. For this purpose, 6 predetermined blocks based on possible arrangements in two modes in blocks were used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Unstable Angina.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 90 patients, will be divided randomly into two intervention and control groups, randomly. After getting written consent, they will complete demographic and Seattle Angina questionnaire will be completed. Then, self-care program education will be carried out based on Orem theory for intervention group and the control group will receive usual nursing cares. After one months, questionnaire of quality of life will be completed for both group and the results will be evaluated statistically. After the intervention,   Self-care program based on Orem's self-care model that includes a selection of information, attitudes and practices that  Based on the needs of Unstable Angina  patients in 4 to 6 sessions of 45 minutes taught them.Seattle Questionnaire is a special questionnaire whose validity and reliability in Iran by Taheri Kharameh et al. In 2012 with 85% -59% and the reliability coefficient of retest (ICC) in two times and two weeks apart in all dimensions was 90% This questionnaire includes 19 questions that measure five dimensions of coronary heart disease. 9 questions of physical function, 1 question of angina stability, 2 questions of recurrence of pain, 4 questions of satisfaction with treatment, 3 questions of understanding quality of life by summing the scores of questions and converting to 0 scale. 100 is calculated. 0 will be the worst and 100 will be the best. Intervention 2: Control group: control group will receive usual nursing cares.</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 The research findings are completely limited in study and are likely to be met with a lower percentage of satisfaction in the current society.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahram molavi nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 1373 8331</telephone>
        <email>shahram.molavi@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab ghaemnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 0613 33217444</telephone>
        <email>zeinabg385@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Include criteria: The diagnosis of unstable angina according to consulting doctor; The lack of a history of mental illness and physical disabilities based on patient records; The lack of a history of heart  surgery in the last 6 months based on patient records; Residence in the city of ahvaz ; Lack of cognitive, hearing, and vision impairment; Lack of education in the department of medicine; Lack of formal training in unstable ungina  patients; Having the ability and willingness to participate in the study; Ability to make phone calls</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclude criteria: Lack of access with the patient by telephone and his family during the study (several times in a few days) ; Patient's unwillingness to continue participation in the study; Death due to illness or the occurrence of any event and the deterioration of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unstable angina</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 90 patients, will be divided randomly into two intervention and control groups, randomly. After getting written consent, they will complete demographic and Seattle Angina questionnaire will be completed. Then, self-care program education will be carried out based on Orem theory for intervention group and the control group will receive usual nursing cares. After one months, questionnaire of quality of life will be completed for both group and the results will be evaluated statistically. After the intervention,   Self-care program based on Orem's self-care model that includes a selection of information, attitudes and practices that  Based on the needs of Unstable Angina  patients in 4 to 6 sessions of 45 minutes taught them.Seattle Questionnaire is a special questionnaire whose validity and reliability in Iran by Taheri Kharameh et al. In 2012 with 85% -59% and the reliability coefficient of retest (ICC) in two times and two weeks apart in all dimensions was 90% This questionnaire includes 19 questions that measure five dimensions of coronary heart disease. 9 questions of physical function, 1 question of angina stability, 2 questions of recurrence of pain, 4 questions of satisfaction with treatment, 3 questions of understanding quality of life by summing the scores of questions and converting to 0 scale. 100 is calculated. 0 will be the worst and 100 will be the best.</i_keyword>
      <i_keyword>Control group: control group will receive usual nursing cares.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care training program. Timepoint: before intervention and 2 months after intervention. Method of measurement: Seattle Angina Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical function. Timepoint: before intervention and 1 months after intervention. Method of measurement: Seattle Angina questionnaire.</sec_outcome>
      <sec_outcome>Stable angina. Timepoint: before intervention and 1 months after intervention. Method of measurement: Seattle Angina Questionnaire.</sec_outcome>
      <sec_outcome>Repeat pain. Timepoint: before intervention and 1 months after intervention. Method of measurement: Seattle Angina Questionnaire.</sec_outcome>
      <sec_outcome>Satisfaction with treatment. Timepoint: before intervention and 1 months after intervention. Method of measurement: Seattle Angina Questionnaire.</sec_outcome>
      <sec_outcome>Perception of pain. Timepoint: before intervention and 1 months after intervention. Method of measurement: Seattle Angina Questionnaire.</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>Ahvaz Jundishapur University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-04</approval_date>
        <contact_name>Ethics committee of Ahvaz university of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
