<?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>IRCT20161213031398N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-21</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of cognitive readiness</public_title>
      <acronym></acronym>
      <scientific_title>Development and evaluation of the effectiveness of cognitive readiness on stress reactivity, physiological health parameters, optimal decision making and brain wave patterns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: People volunteering to participate in the research are randomly assigned to two experimental and control groups. In this regard, a number is assigned to all the people and the people of two groups are determined by drawing lots. In this way, in simple randomization with this method, the numbers related to all sample people are first written on sheets and then placed inside the container; Then, half of the cards are drawn from the container. The removed cards are placed in the experimental group and the remaining cards are placed in the control group. Then, if the two groups were equal in terms of demographic characteristics, the assignment ends, and if not, the above process is repeated until the equality of the two groups is achieved, Blinding description: The participants are fully aware of the research objectives in their group, but they do not know which group they are in (experimental or control) and they are kept unaware of the research objectives in the other group. Also, A and B codes are sent to the analyst for intervention and control groups so that he does not know about the type of groups. Blinding of the outcome assessor will be ensured by his lack of knowledge about the allocation group of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: cognitive readiness training during 72 sessions with the headings of cognitive readiness (definition and explanation of cognitive readiness, necessity, goals and expectations, definition of skills, knowledge and insight as the main factors of cognitive readiness), situational awareness (teaching concepts related to three levels of awareness situational awareness, statement of theories of situational awareness, investigation of factors enhancing situational awareness, investigation of factors hindering situational awareness, practical exercises of situational awareness, exercise of assessing situational awareness, exercise of mindfulness with situational awareness). Metacognitive skills (step-by-step training of concepts related to metacognition. Training of cognitive strategies such as summarizing topics, taking notes and practicing retelling of content. Training of planning strategies. Training of monitoring control strategy, techniques for controlling the effectiveness of activities, searching for reasons, questioning oneself for control. self, training to adjust reaction time to social actions, training strategy including adjustment, modification or change of cognitive and emotional strategy). Problem solving skills (teaching theoretical basics based on the seven-step method). Creative thinking (teaching theoretical concepts, examining the stages of creative thinking, examining the characteristics of creative people, brainstorming technique, lotus blossom technique). Intervention 2: Control group: Without effective 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 Due to the military example, I do not intend to detail the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Isaac Rahimian Boogar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111556</zip>
        <telephone>+98 23 3362 3300</telephone>
        <email>i_rahimian@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Isaac Rahimian Boogar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdishahr Faculty of Psychology and Educational Sciences, Darband, Mahdishahr, Semnan,</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111556</zip>
        <telephone>+98 23 3362 3300</telephone>
        <email>i_rahimian@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious consent to participate in research
Age between 30 to 40 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having mental and physical disorders
High blood pressure and high blood fats
Sight and hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: cognitive readiness training during 72 sessions with the headings of cognitive readiness (definition and explanation of cognitive readiness, necessity, goals and expectations, definition of skills, knowledge and insight as the main factors of cognitive readiness), situational awareness (teaching concepts related to three levels of awareness situational awareness, statement of theories of situational awareness, investigation of factors enhancing situational awareness, investigation of factors hindering situational awareness, practical exercises of situational awareness, exercise of assessing situational awareness, exercise of mindfulness with situational awareness). Metacognitive skills (step-by-step training of concepts related to metacognition. Training of cognitive strategies such as summarizing topics, taking notes and practicing retelling of content. Training of planning strategies. Training of monitoring control strategy, techniques for controlling the effectiveness of activities, searching for reasons, questioning oneself for control. self, training to adjust reaction time to social actions, training strategy including adjustment, modification or change of cognitive and emotional strategy). Problem solving skills (teaching theoretical basics based on the seven-step method). Creative thinking (teaching theoretical concepts, examining the stages of creative thinking, examining the characteristics of creative people, brainstorming technique, lotus blossom technique)</i_keyword>
      <i_keyword>Control group: Without effective intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress reactivity. Timepoint: 1 and 50 days, pre-test and post-test. Method of measurement: stress reactivity questionnaire.</prim_outcome>
      <prim_outcome>Physiological health indicators include body mass index (BMI), body fat index (BF), blood serum cholesterol (BSC) and systolic and diastolic blood pressure. Timepoint: 1 and 50 days, pre-test and post-test. Method of measurement: Calculating the ratio of weight to the square of height, the ratio of height and waist circumference per meter, taking 100 cc of blood, digital blood pressure monitor.</prim_outcome>
      <prim_outcome>Optimal decision making using strategic management simulation. Timepoint: 1 and 50 days, pre-test and post-test. Method of measurement: Using a computer simulator for 50 minutes and recording scores from reactions and decisions.</prim_outcome>
      <prim_outcome>Recording of brain waves from the QEEG recording device. Timepoint: 1 and 50 days, pre-test and post-test. Method of measurement: Recording of four waves of delta, theta, alpha, and beta in 19 regions of the brain.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-28</approval_date>
        <contact_name>Research Ethics Committees of Semnan University Of Medical Sciences and Health Services</contact_name>
        <contact_address>Semnan Province, Semnan City, Basij Boulevard, University of Medical Sciences and Healthcare Services Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
