<?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>IRCT20130616013690N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of professional support intervention through social network on patients with implantable cardiac defibrillator</public_title>
      <acronym></acronym>
      <scientific_title>The effect of professional support intervention through social network on fatigue, shock anxiety and acceptance of implantable cardiac defibrillator</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60738</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, 72 patients who have record in the pacemaker and ICD clinics of Shahid Faghihi and Kosar hospitals in Shiraz will be selected using a random number table. Then, random allocation software will be used to create 18 blocks of size 4. Then based on the list generated by this software (BABA, ABBA, BAAB, BABA, AABB, ...), individuals are assigned into the intervention (B) and control (A) groups, Blinding description: In order to provide blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Implantable cardiac defibrillator.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Professional support intervention is done daily for patients through social network WhatsApp for 4 weeks. Contents are prepared in the form of text, audio and videos (MP4) prepared with Camtasia software. The patients communicate in the WhatsApp group for two hours daily and at a specific time. At the same time, they communicate with the researcher in her privet page via WhatsApp in the form of text and audio. The intervention focus on provide content about the functioning of the cardiovascular system, how the cardiac defibrillator works and its impact on life and self-care, the emotional effects of having a defibrillator (worry about body image, and negative emotions), impact of this device on communications and roles, how emotional reactions affect on coping, spiritual and social strategies for coping to the device, and living with cardiac defibrillator. Moreover, Contents are also prepared on social support, support exchanges and people on the individual's social network, and the types of social support appropriate to their illness. Intervention 2: Control group: This group typically receives medical care and will not receive any of the interventions that individuals in the intervention group receive.</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:
Primary outcomes would be shared.

When:
Starting 6 months after publication article

To whom:
People and researchers working in academic institutions

Conditions:
Data are provided for information only.

Where to obtain:
Data is available via email rambodma@yahoo.com.

How to obtain:
Data is available via email rambodma@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936–13119</zip>
        <telephone>+98 71 3677 4254</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 18 years old or above
Having implantable cardiac defibrillator
Ability to speak Persian
Access to the Internet and social networks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are a known case of mental health disorders such as depression, anxiety, and psychosis.
Patients had an emotional crisis such as the death of loved ones and getting a divorce past 6 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.810</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of automatic (implantable) cardiac defibrillator</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Professional support intervention is done daily for patients through social network WhatsApp for 4 weeks. Contents are prepared in the form of text, audio and videos (MP4) prepared with Camtasia software. The patients communicate in the WhatsApp group for two hours daily and at a specific time. At the same time, they communicate with the researcher in her privet page via WhatsApp in the form of text and audio. The intervention focus on provide content about the functioning of the cardiovascular system, how the cardiac defibrillator works and its impact on life and self-care, the emotional effects of having a defibrillator (worry about body image, and negative emotions), impact of this device on communications and roles, how emotional reactions affect on coping, spiritual and social strategies for coping to the device, and living with cardiac defibrillator. Moreover, Contents are also prepared on social support, support exchanges and people on the individual's social network, and the types of social support appropriate to their illness.</i_keyword>
      <i_keyword>Control group: This group typically receives medical care and will not receive any of the interventions that individuals in the intervention group receive.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before and 4 weeks after the intervention. Method of measurement: Multidimensional Fatigue Inventory.</prim_outcome>
      <prim_outcome>Shock anxiety. Timepoint: Before and 4 weeks after the intervention. Method of measurement: Florida Shock Anxiety Scale.</prim_outcome>
      <prim_outcome>Acceptance of implantable cardiac defibrillator. Timepoint: Before and 4 weeks after the intervention. Method of measurement: Florida Patient Acceptance Survey.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-22</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery, Management and Medical Information Sc</contact_name>
        <contact_address>Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
