<?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>IRCT20190107042272N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-27</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effects of mobile waves on cognitive and executive functions of the brain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of mobile waves on cognitive and executive functions of the brain in healthy female students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36752</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Education/Guidance, Randomization description: Participants are dividing into two groups by simple randomization method and using statistical software. The first group is exposed to mobile waves in the first session and the second group exposure is in the second session, Blinding description: Participants are unaware of in which session they are being exposed to mobile waves.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effects of mobile waves on cognitive and executive functions of the brain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: At the first session (intervention), people sit on a chair and the cell phone is placed on the head with their left ear. The call is made from the outside of the scope of the call by using the headset.To eliminate the effect of noise on the measured values, the silencer used and voice also plays in both sessions. It should be noted that, the participant is unaware of the call service. After the call, the person is trained to do the tests. After about 5 to 7 minutes, the cognitive tests are performed by the participant, respectively, and the results are stored. During the second session (control), all Interventions are seemed to be performed, but exposure to mobile waves is not taking place. Intervention 2: Second intervention group: In the first session (control), all interventions are apparently performed, but exposure to mobile waves is not performed. At the second session (exposure), after the visit, people sit on a chair and the mobile phone is placed on the head with their left ear. To eliminate the effect of noise on the measured values, the silencer is used and voice also plays in this session. After the call, the person is trained to do the tests. After about 5 to 7 minutes, the cognitive tests are performed by the participant, respectively, and the results are stored.</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 No more information exists.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Heiydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar province Building, Alley 3,Eghlimi Ave., 22 Bahman Blvd., Pardisan Town</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3749183449</zip>
        <telephone>+98 21 6680 7822</telephone>
        <email>fatemeh.heiydari@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Heiydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar province Building, Alley 3,Eghlimi Ave., 22 Bahman Blvd., Pardisan Town</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3749183449</zip>
        <telephone>+98 21 6680 7822</telephone>
        <email>fatemeh.heiydari@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who are right-handed.
People living in dormitories who have the same nutrition.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Anxiety test score of Beck anxiety inventory more than 15.
Depression test score from Beck Depression Inventory more than 17.</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>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: At the first session (intervention), people sit on a chair and the cell phone is placed on the head with their left ear. The call is made from the outside of the scope of the call by using the headset.To eliminate the effect of noise on the measured values, the silencer used and voice also plays in both sessions. It should be noted that, the participant is unaware of the call service. After the call, the person is trained to do the tests. After about 5 to 7 minutes, the cognitive tests are performed by the participant, respectively, and the results are stored. During the second session (control), all Interventions are seemed to be performed, but exposure to mobile waves is not taking place.</i_keyword>
      <i_keyword>Second intervention group: In the first session (control), all interventions are apparently performed, but exposure to mobile waves is not performed. At the second session (exposure), after the visit, people sit on a chair and the mobile phone is placed on the head with their left ear. To eliminate the effect of noise on the measured values, the silencer is used and voice also plays in this session. After the call, the person is trained to do the tests. After about 5 to 7 minutes, the cognitive tests are performed by the participant, respectively, and the results are stored.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Minimum of Reaction Time. Timepoint: After 5 to 7 minutes from the arrival of the person to the test site in two sessions without exposed and exposed to mobile waves. Method of measurement: Reaction Time Test.</prim_outcome>
      <prim_outcome>Average reaction time. Timepoint: After 5 to 7 minutes from the arrival of the person to the test site in two sessions without exposed and exposed to mobile waves. Method of measurement: Reaction Time Test.</prim_outcome>
      <prim_outcome>Average response time. Timepoint: Immediately after doing the Reaction Time test in two sessions without exposed and exposed to mobile waves. Method of measurement: Stroop Test.</prim_outcome>
      <prim_outcome>Number of errors. Timepoint: Immediately after doing the Reaction Time test in two sessions without exposed and exposed to mobile waves. Method of measurement: Stroop Test.</prim_outcome>
      <prim_outcome>Average response time. Timepoint: Immediately after doing the Stroop test in two sessions without exposed and exposed to mobile waves. Method of measurement: Stroop effect test.</prim_outcome>
      <prim_outcome>Number of errors. Timepoint: Immediately after doing the Stroop test in two sessions without exposed and exposed to mobile waves. Method of measurement: Stroop effect test.</prim_outcome>
      <prim_outcome>Average response time. Timepoint: Immediately after doing the Wisconsin Card Sorting test in two sessions without exposed and exposed to mobile waves. Method of measurement: Time perception test.</prim_outcome>
      <prim_outcome>Minimum of response time. Timepoint: Immediately after doing the Wisconsin Card Sorting test in two sessions without exposed and exposed to mobile waves. Method of measurement: Time perception test.</prim_outcome>
      <prim_outcome>Number of Correct responses. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Errors. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Perseverative response. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Perseverative errors. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Non-Perseverative errors. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Unique Errors. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number trials to complete the first pattern. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of Failure to maintain set. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting test.</prim_outcome>
      <prim_outcome>Number of conceptual level responses. Timepoint: Immediately after doing the Stroop Effect test in two sessions without exposed and exposed to mobile waves. Method of measurement: Wisconsin card sorting 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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-01</approval_date>
        <contact_name>Ethics Committee in Biomedical Research of Qom University of Medical Sciences</contact_name>
        <contact_address>No. 83, Alley No. 4, Alley No. 1/1, Safashahr Ave Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
