<?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>IRCT20190822044581N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-29</date_registration>
      <primary_sponsor>, Islamic Azad University, Yasuj Branch</primary_sponsor>
      <public_title>The effect of eye movements desensitization and reprocessing on death anxiety, cognitive function and improvement active memory in patients with myocardial infarction in Yasuj city</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eye movements desensitization and reprocessing on death anxiety, cognitive function and improvement active memory in patients with myocardial infarction in Yasuj city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The studied samples were divided into two groups through block random allocation process. Thus, first by multiplying the number of groups studied (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation the number of samples of each block (24 = 1 × 2 × 3 × 4 =! 4) The number of blocks resulting from all states of arrangement of individuals, 24 calculated blocks and blocks involving the possible arrangement of individuals were considered as A and C for the intervention group and B and D for the control group as follows:
12	11	10	9	8	7	6	5	4	3	2	1
BDCA	BDAC	BCDA	BCAD	BADC	BACD	ADCB	ADBC	ACDB	ACBD	ABDC	ABCD
24	23	22	21	20	19	18	17	16	15	14	13
DCBA	DCAB	DBCA	DBAC	DACB	DABC	CDBA	CDAB	CBDA	CBAD	CADB	CABD
Since the number of people in each block was 4 people and the estimated sample size was 60 people, so by matching 20 random numbers generated by the Sample Randomizer software with the number of the above blocks, how to arrange 60 people research simple and assign each number from one to Sixty to one of the specific intervention and control groups and a block random allocation list were compiled.
In order to create sequences and concealment, online software with the following address will be used, and a special randomization code will be generated.
Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 18Jun 2022.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Death anxiety, cognitive function, working memory.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving routine medical care, patients in the experimental group will be treated with ocular desensitization and reprocessing according to the standard 8-step protocol for one to two weeks for 6 one-hour sessions. The treatment will be performed in the cardiac counseling room and in the medical and educational environment of the hospital or in a private place and counseling centers with the consultation and coordination of the group therapy (researcher and cardiologist consultant). Intervention 2: Control group: In the control group patients during this period will receive only routine care such as doctor's visit and medication and nursing interventions related to the disease and no therapeutic intervention will be performed by the researcher. Patients in this group will complete questionnaires of death anxiety, cognitive function and working memory improvement both at the beginning of the intervention and immediately after the intervention.</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 It will be updated after talking to the samples about the publishing process</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ali Reza Maredpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sisakht Road, Islamic Azad University, Yasuj Branch, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591493686</zip>
        <telephone>+98 74 3331 3213</telephone>
        <email>ali.mared@yahoo.com</email>
        <affiliation>Islamic Azad University, Yasuj Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Reza Maredpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sisakht Road, Islamic Azad University, Yasuj Branch, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591493686</zip>
        <telephone>+98 74 3331 3213</telephone>
        <email>ali.mared@yahoo.com</email>
        <affiliation>, Islamic Azad University, Yasuj Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosis of myocardial infarction by a cardiologist,  
stable hemodynamic status of patients
no vision problems
maximum age 60
having a minimum literacy
ability to listen normally
Informed consent to participate in treatment sessions</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of mental disorders requires immediate treatment</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>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving routine medical care, patients in the experimental group will be treated with ocular desensitization and reprocessing according to the standard 8-step protocol for one to two weeks for 6 one-hour sessions. The treatment will be performed in the cardiac counseling room and in the medical and educational environment of the hospital or in a private place and counseling centers with the consultation and coordination of the group therapy (researcher and cardiologist consultant).</i_keyword>
      <i_keyword>Control group: In the control group patients during this period will receive only routine care such as doctor's visit and medication and nursing interventions related to the disease and no therapeutic intervention will be performed by the researcher. Patients in this group will complete questionnaires of death anxiety, cognitive function and working memory improvement both at the beginning of the intervention and immediately after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death anxiety in cardiovascular patients. Timepoint: At the beginning of the intervention and immediately after the end of the intervention. Method of measurement: Templer Death anxiety scale.</prim_outcome>
      <prim_outcome>Cognitive Function. Timepoint: At the beginning of the intervention and immediately after the end of the intervention. Method of measurement: Cognitive Function Questionnaire of Foulestin et al. 1975.</prim_outcome>
      <prim_outcome>Measure working memory. Timepoint: At the beginning of the intervention and immediately after the end of the intervention. Method of measurement: Wechsler working memory test.</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, Yasuj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - Yasouj Branch</contact_name>
        <contact_address>Sisakht Road, Islamic Azad University, Yasuj Branch، Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
