<?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>IRCT20210823052263N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-14</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of desensitization with eye movements and reprocessing on the recovery of patients with COVID-19</public_title>
      <acronym>EMDR</acronym>
      <scientific_title>Evaluation of the effect of desensitization with eye movements and reprocessing on anxiety, hemodynamic parameters and duration of hospitalization in patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For select the determined sample size of the study, a simple randomization method is used, in this way, a list of patients referred to Shahid Jalil Yasouj Hospital who meet the criteria for entering the study was prepared and with the help of a table of numbers The samples are randomly selected so that first a row or column is randomly selected and the direction of movement in the table is from left to right and then the numbers in each row or column equal to the previous one are assigned to one of the intervention or control groups and the number The pair equivalent to the intervention group and the odd number equivalent to the control group will be selected and in this way 45 samples will be selected for the intervention group and 45 samples will be selected for the control group, Blinding description: This study will be double-blind, in such a way that the patients and researchers will be blinded. In this way, the patients and the researcher who measures the desired outcome do not know at first which people are the intervention group and which are the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: The desensitization method with eye movements in the intervention group will be performed individually for each patient in three sessions and one session of 45 to 90 minutes each day. This is an eight-step method that emphasizes the physiological information processing system in the origin and treatment of mental health problems. The steps of this method in order and summary are history, explanation and preparation, investigation, target desensitization, creating positive cognition, processing the body. , creating positive recognition, ending the meeting and re-evaluating previously processed goals. Intervention 2: The control group will receive the drugs prescribed by the doctor for the treatment of COVID-19 according to the standard protocols. However, no psychotherapeutic intervention will be performed on this group during the research.</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:
Part of the data in the excel or spss file

When:
6 months after the publication of the article

To whom:
Academic researchers

Conditions:
Using data for analysis using statistical models

Where to obtain:
Amin Haghoo
Email: amin.haghgoo65@gmail.com

How to obtain:
Official request from the university or research institute

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Haghgoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza Street</address>
        <city>yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7594118438</zip>
        <telephone>+98 74 3333 7001</telephone>
        <email>amin.haghgoo65@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Haghgoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Raza Street</address>
        <city>yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7594118438</zip>
        <telephone>+98 74 3333 7001</telephone>
        <email>amin.haghgoo65@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 65 years old
Patients with COVID-19 who are PCR positive
Has one or more clinical symptoms including fever less than or more than 38, sore throat with or without dry cough, chills, headache, loss of taste and smell, nausea and vomiting, anorexia, diarrhea, body aches, weakness and extreme tiredness Which has no other definite justification, and spo2 = 80-93, shortness of breath, feeling of pain or pressure in the chest
No visual impairment and strabismus
No cognitive impairment such as dementia or Alzheimer's
Has no history of seizures
Has no history of known mental disorder
Not to be addicted to drugs
Patients' anxiety level should be moderate to high according to Hamilton Anxiety Questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient did not cooperate with the therapist
The patient has entered a severe phase due to pulmonary involvement and needs a niv mask or intubation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U08.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The desensitization method with eye movements in the intervention group will be performed individually for each patient in three sessions and one session of 45 to 90 minutes each day. This is an eight-step method that emphasizes the physiological information processing system in the origin and treatment of mental health problems. The steps of this method in order and summary are history, explanation and preparation, investigation, target desensitization, creating positive cognition, processing the body. , creating positive recognition, ending the meeting and re-evaluating previously processed goals.</i_keyword>
      <i_keyword>The control group will receive the drugs prescribed by the doctor for the treatment of COVID-19 according to the standard protocols. However, no psychotherapeutic intervention will be performed on this group during the research</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Hamilton questionnaire. Timepoint: Before intervention and after intervention. Method of measurement: Hamilton anxiety questionnaire.</prim_outcome>
      <prim_outcome>Hemodynamic status (blood pressure, respiration, oxygen saturation level) with patient monitoring. Timepoint: Before intervention and after intervention. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: Before intervention and after intervention. Method of measurement: Date of admission and discharge included in the file.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep Quality Scale. Timepoint: At the beginning of the study and one and three months after the intervention. Method of measurement: Pittsburgh Sleep Quality 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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-01</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Shahid Motahari Boulevard, No. 105 Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
