<?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>IRCT20210202050219N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-08</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education on stress and anxiety of COVID-19 patients' caregivers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-centered education on stress and anxiety of COVID-19 patients' caregivers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54110</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this way, patients who are admitted on even days of the week will be assigned to the experimental group and patients who are admitted on odd days of the week will be assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the family-centered training program will be implemented individually for caregivers of patients with COVID-19. The family-centered training program begins at the beginning of the patient's hospitalization. The researcher will stay with the family and answer their questions, concerns and feelings. On the first and second days of hospitalization, caregivers will be taught about the nature of COVID-19 disease, common symptoms, treatment, and ways of transmitting the disease, especially prevention methods when dealing with a patient. Third and fourth days in connection with post-discharge care, which includes patient care during quarantine, proper use of personal protection for the patient and family members, how to disinfect the environment, patient clothes and dishes, and proper diet for the patient and family members , Danger signs and the patient's return to the hospital, the caregivers are trained and the educational pamphlet prepared in this field is delivered to the patients. Intervention 2: Control group: it will be treated according to routine and the educational intervention mentioned in the research will not be performed.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Jamal tayarani Darbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences,Imam Khomeini St,Khorasan Razavi, Gonabad,</address>
        <city>gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3513</telephone>
        <email>sdh@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Jamal tayarani Darbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences,Imam Khomeini St.,Khorasan Razavi, Gonabad,</address>
        <city>gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 3623 8747</telephone>
        <email>black.kourosh@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A primary family member and primary caregiver of patients admitted to the infectious diseases ward
No history of illness and mental disorders based on the patient's history and self-declaration
Education at least the end of elementary school
Lack of health jobs
Not taking care of another person at the same time
Have no hearing (full sitting despite the use of assistive devices) and visual (inability to read the newspaper at a distance of 30 cm with or without glasses) problems
Being in the age range of 18 to 70 years old
No family history of death due to COVID-19</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation
Change of person accompanying the patient (main caregiver)
Infection (main caregiver) of COVID-19 disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.0</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the family-centered training program will be implemented individually for caregivers of patients with COVID-19. The family-centered training program begins at the beginning of the patient's hospitalization. The researcher will stay with the family and answer their questions, concerns and feelings. On the first and second days of hospitalization, caregivers will be taught about the nature of COVID-19 disease, common symptoms, treatment, and ways of transmitting the disease, especially prevention methods when dealing with a patient. Third and fourth days in connection with post-discharge care, which includes patient care during quarantine, proper use of personal protection for the patient and family members, how to disinfect the environment, patient clothes and dishes, and proper diet for the patient and family members , Danger signs and the patient's return to the hospital, the caregivers are trained and the educational pamphlet prepared in this field is delivered to the patients.</i_keyword>
      <i_keyword>Control group: it will be treated according to routine and the educational intervention mentioned in the research will not be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in the DASS questionnaire. Timepoint: Measurement of stress score at the beginning of the study (before the intervention) and day 4 after the intervention. Method of measurement: DASS questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score in the DASS questionnaire. Timepoint: Measurement of anxiety score at the beginning of the study (before the intervention) and day 4 after the intervention. Method of measurement: DASS 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-09</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Medical University of Gonabad, Imam Khomeini Avenue Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
