<?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>IRCT20240626062258N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-29</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-management program based on social-cognitive theory on anxiety and sleep quality of cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the self-management program based on Social cognitive theory on the anxiety and sleep quality of acute coronary syndrome in patients hospitalized in the coronary care unit of Hajar Hospital of Shahrekord</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79435</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The research samples will be easily selected from patients with acute coronary syndrome who are eligible to enter the study and give informed consent to participate in the study. Then, the samples will be placed in two groups of 36 people, test and control, by random block method in the form of blocks of four (2 test persons and 2 control persons) and 18 blocks that are chosen randomly, Blinding description: None of the participants know whether they are in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Coronary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Within one or two days after the patient is admitted to the cardiac intensive care unit and his condition stabilizes, the researcher will guide the patient and his companions on how to access the virtual group and how to participate in the training program and provide practical explanations for 15 to 30 minutes. He will be present at the bedside of patients. Then, according to his access to the Ita social network, he will be a member in the virtual group. After obtaining the desired sample and his membership in the above-mentioned virtual groups, the link to the questionnaire will be designed and the necessary explanations about its completion will be sent on the platform of the virtual space. . Due to the anticipated lack of immediate access to the Internet for the participants, 3 days will be considered from the time of sending the questionnaires to complete and send them, and if they do not receive the message, they will be informed of this through a phone call. Also, in the created virtual groups, questions and answers will be open for group members. The intervention for the test group will be based on Bandura's social-cognitive theory. This intervention, which includes a self-management training program in three areas of cognitive, environmental and behavioral, was mentioned during 6 30-minute sessions virtually and via mobile phone in the form of a virtual group on the social network Ita, and after the patient became stable for The group test will be done. In general, the above-mentioned 6 intervention sessions will include two training sessions focused on individual characteristics, two sessions focused on behavioral training, and two sessions focused on the adjustment of environmental factors. At the end of the sixth session, the researcher will also use research questionnaires (Beck Anxiety Questionnaire and Pittsburgh Quality Questionnaire). will be uploaded in the virtual group and will be made available again to the people of the intervention group to complete it. In this stage, as in the first stage, the participants will be given 3 days from the time of sending the questionnaires to complete and send them, and all measures for Face-to-face and virtual response is also established as in the first stage. In the continuation of the research program, a follow-up program will be carried out, based on which, once a week for eight weeks, a telephone call will be made with the patients of the test group or their companions. The content of the phone call will be to strengthen education and verbal encouragement and ask questions about the patient's condition and answer the patients' questions and doubts. After completing the phone follow-up sessions and providing appropriate guidance and training, the anxiety and sleep quality questionnaire will be administered again in virtual groups. The loading will be completed by the patient or his companions, obviously, according to the previous two stages, a period of 3 days will be allocated to the participants to answer the questionnaires, and the researcher will be available to answer in person. Intervention 2: Control group: The control group will only participate in the pre-test, post-test and follow-up stages, thus the patients in the control group will not receive the same intervention as what is considered for the test group, and they will only receive routine care provided by They receive what the hospital offers them.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhaneh Eskandarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8، Block 4، Alley 2،Golbahar Street، Baharestan Street</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815969890</zip>
        <telephone>+98 913 483 7084</telephone>
        <email>R.eskandarian72@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirmohammad Davoodvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery، Rahmatieh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>881596980</zip>
        <telephone>+98 913 483 7084</telephone>
        <email>Shdavodvand@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definite diagnosis of acute coronary syndrome based on the opinion of a specialist doctor or a history of hospitalization in a special department following acute coronary syndrome
Obtain a minimum score of 8 from Beck's anxiety questionnaire
Age over 18 years
Willingness and written informed consent to participate in the study
Able to read and write
She/he has not participated in other research projects in this field
Implementation of a self-management program based on cognitive-social theory after the patient's discharge from the cardiac intensive care unit, stabilization of the patient's condition and stabilization of hemodynamic symptoms.
Access to the Internet and social network by the patient or her companion and the ability to work with the program</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incomplete completion of questionnaires
Membership in the health team
Urgent clinical conditions of patients and occurrence of acute complications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Within one or two days after the patient is admitted to the cardiac intensive care unit and his condition stabilizes, the researcher will guide the patient and his companions on how to access the virtual group and how to participate in the training program and provide practical explanations for 15 to 30 minutes. He will be present at the bedside of patients. Then, according to his access to the Ita social network, he will be a member in the virtual group. After obtaining the desired sample and his membership in the above-mentioned virtual groups, the link to the questionnaire will be designed and the necessary explanations about its completion will be sent on the platform of the virtual space. . Due to the anticipated lack of immediate access to the Internet for the participants, 3 days will be considered from the time of sending the questionnaires to complete and send them, and if they do not receive the message, they will be informed of this through a phone call. Also, in the created virtual groups, questions and answers will be open for group members. The intervention for the test group will be based on Bandura's social-cognitive theory. This intervention, which includes a self-management training program in three areas of cognitive, environmental and behavioral, was mentioned during 6 30-minute sessions virtually and via mobile phone in the form of a virtual group on the social network Ita, and after the patient became stable for The group test will be done. In general, the above-mentioned 6 intervention sessions will include two training sessions focused on individual characteristics, two sessions focused on behavioral training, and two sessions focused on the adjustment of environmental factors. At the end of the sixth session, the researcher will also use research questionnaires (Beck Anxiety Questionnaire and Pittsburgh Quality Questionnaire). will be uploaded in the virtual group and will be made available again to the people of the intervention group to complete it. In this stage, as in the first stage, the participants will be given 3 days from the time of sending the questionnaires to complete and send them, and all measures for Face-to-face and virtual response is also established as in the first stage. In the continuation of the research program, a follow-up program will be carried out, based on which, once a week for eight weeks, a telephone call will be made with the patients of the test group or their companions. The content of the phone call will be to strengthen education and verbal encouragement and ask questions about the patient's condition and answer the patients' questions and doubts. After completing the phone follow-up sessions and providing appropriate guidance and training, the anxiety and sleep quality questionnaire will be administered again in virtual groups. The loading will be completed by the patient or his companions, obviously, according to the previous two stages, a period of 3 days will be allocated to the participants to answer the questionnaires, and the researcher will be available to answer in person.</i_keyword>
      <i_keyword>Control group: The control group will only participate in the pre-test, post-test and follow-up stages, thus the patients in the control group will not receive the same intervention as what is considered for the test group, and they will only receive routine care provided by They receive what the hospital offers them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Beck's questionnaire. Timepoint: Before starting the study, immediately after the training and eight weeks after the training. Method of measurement: Beck index questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score in the Pittsburgh Questionnaire. Timepoint: Before starting the study, immediately after the training and eight weeks after the training. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-07</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Baharestan Street, Gallaher Street, Alley 2, No. 4, Unit 8 Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
