<?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>IRCT20201205049610N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of cognitive-behavioral stress management on Covid 19 patients</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive-behavioral stress management using the remote care system (application) of Covid 19 patients on the severity and duration of symptoms of this disease, psychological symptoms, psychosocial adaptation, cognitive status and changes in the level of ferritin and CRP and Spo2 in the blood of Covid 19 patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52881</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample people are selected by simple individual randomization by roll of a dice (numbers 1, 2 and 3 in the experimental group and numbers 4, 5 and 6 in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: training cognitive and behavioral techniques for stress management using the covid 19 Remote Care System (application) that is given to these patients online. Intervention 2: Control group: for the control group, only routine medical and nursing care and recommendations and nutrition training is taught.</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:
All individual data of study participants will be shared after Unidentifiable Persons

When:
Access permission, three months after printing the results

To whom:
Researchers working in academic and scientific institutions, health care workers

Conditions:
Use to conduct similar research or to discover relationships and correlations or to conduct structural equation research and path analysis

Where to obtain:
Communicate with Mr. Hossein Hosseini Naveh at E.mail: mn.h.h.naveh@gmail.com

How to obtain:
Documents will be sent to their email by providing evidence of their Necessity need for data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Hosseini naveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.46; Unit 3; Mohammad Complex; Alley 5 (Salman); Stadium St; East Baharestan St; Kaveh St; Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8196773393</zip>
        <telephone>+98 31 3432 2616</telephone>
        <email>mn.h.h.naveh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Hosseini naveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.46; Unit 3; Mohammad Complex; Alley 5 (Salman); Stadium St; East Baharestan St; Kaveh St; Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8196773393</zip>
        <telephone>+98 31 3432 2616</telephone>
        <email>mn.h.h.naveh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Covid 19 patients who have not been spend more than 5 days after the onset of their first symptoms and have been discharged from the hospital to continue quarantine at home.
Having a smartphone
Being literate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are too old or illiterate that to find information from them is difficult</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: training cognitive and behavioral techniques for stress management using the covid 19 Remote Care System (application) that is given to these patients online</i_keyword>
      <i_keyword>Control group: for the control group, only routine medical and nursing care and recommendations and nutrition training is taught</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity and duration of Covid 19 disease symptoms. Timepoint: Daily monitoring of symptoms of covid 19 disease, from the first day of entry into the study to 21 days. Method of measurement: Evaluation of symptom severity by daily fever measurement and body pain scoring with McGill Pain Questionnaire and weakness scoring with Energy / Fatigue subscale from Quality of Life Questionnaire. duration of covid 19 disease symptoms by daily symptom monitoring and number of days recorded that each of the subjects experiences symptoms.</prim_outcome>
      <prim_outcome>Score of psychological symptoms (depression, anxiety and stress) in the 21-question questionnaire of depression, anxiety and stress Laweibond and Laweibond 1995. Timepoint: Perform pre-test before the intervention and post-test after the intervention. Method of measurement: Measurement of this variable using 21-question questionnaire of depression, anxiety and stress Laweibond and Laweibond 1995.</prim_outcome>
      <prim_outcome>Psychosocial adaptation. Timepoint: Perform pre-test before the intervention and post-test after the intervention. Method of measurement: Measurement of this variable using the 160-question  Bell  Psychosocial Adjustment Questionnaire 1961.</prim_outcome>
      <prim_outcome>Cognitive status. Timepoint: Perform pre-test before the intervention and post-test after the intervention. Method of measurement: Measurement of this variable using the standard questionnaire of  Mini-Mental State Examination of Folstein et al. 1975.</prim_outcome>
      <prim_outcome>Changes in ferritin and C-reactive protein blood levels and saturation of peripheral oxygen of covid 19 patients. Timepoint: Perform pre-test before the intervention and post-test after the intervention. Method of measurement: Perform a blood test to check the serum level of ferritin and C-reactive protein in the blood and check the percentage of saturation of peripheral oxygen in the blood using a pulse oximeter in two stages, before and after the intervention.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-29</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Najafaba Branch</contact_name>
        <contact_address>Islamic Azad University Blvd, Najafabad Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
