<?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>IRCT20171006036596N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-11</date_registration>
      <primary_sponsor>The University of Semnan</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Neurofeedback and Mindfulness in Improving Executive Functions among Students</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Neurofeedback and Mindfulness Training in Improving Executive Functions (Attention, Inhibition Response, Working Memory, Planning, and Cognitive Flexibility) among Athletic Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Regarding the entry criteria, simple random method will be used for sampling. The researcher will go to physical education students, and the students will be registered. According to the entry criteria, the eligible individuals will stay and we prepare a list of them. Then, 60 people will be selected randomly and will be assigned to three 20-member groups and, eventually, we allocate the assignments. The randomization unit is of an individual type. Using the random number table, we take out and select the numbers. Due to the limited statistical population, simple random sampling is used. The assignment of numbers to participants is possible only by the researcher, and the other individuals are not aware of these numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal people.</hc_freetext>
      <i_freetext>Intervention 1: Neurofeedback. Participants in the neurofeedback group will undergo sixteen 45-minute sessions of neurofeedback training (beta / theta and theta / SMR protocols) during 8 weeks. Procamp 2 neurofeedback device and BioGraph Infiniti Software will be used in this stage. This device has been made by Thought Technology Company of Canada. Intervention 2: Mindfulness. Participants in the Mindfulness group will receive eight 45-minute sessions of mindfulness training during eight weeks. Intervention 3: Control group. The control group will not receive any training.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Kermani Mamazandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology, Semnan University, Mahdishahr, Semnan</address>
        <city>Mahdishahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111156</zip>
        <telephone>+98 23 3362 3300</telephone>
        <email>z.kermani@semnan.ac.ir</email>
        <affiliation>The University of Semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Kermani Mamazandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology &amp; Educational Sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.</address>
        <city>Mahdishahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111156</zip>
        <telephone>+98 23336233300</telephone>
        <email>z.kermani@semnan.ac.ir</email>
        <affiliation>The University of semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Physical and Mental Health (Not Taking Psychiatric Drugs)
The age range of participants is between 18 and 25 years old
They should be Physical Education students at Bachelor's program (at least second-semester students and at most eighth-semester students).
None of the participants should be familiar with neurofeedback training and mindfulness training.
Having at least the necessary verbal skills and willingness to attend training sessions
Participants should be involved at least in one sport field
No use of any psychotherapy and counseling services at the time of conducting the research or before it
Be a boy student</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Inappropriate physical status (having a medical record), taking psychiatric drugs
Not being fully prepared and satisfied preparation to attend the training sessions
Participants who have undergone surgery in the cranium area or have had a problem with their nervous system. (People with certain diseases in the head area)</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Neurofeedback. Participants in the neurofeedback group will undergo sixteen 45-minute sessions of neurofeedback training (beta / theta and theta / SMR protocols) during 8 weeks. Procamp 2 neurofeedback device and BioGraph Infiniti Software will be used in this stage. This device has been made by Thought Technology Company of Canada.</i_keyword>
      <i_keyword>Mindfulness. Participants in the Mindfulness group will receive eight 45-minute sessions of mindfulness training during eight weeks.</i_keyword>
      <i_keyword>Control group. The control group will not receive any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Planning. Timepoint: Before intervention - after intervention and one month following the end of the last intervention sessions. Method of measurement: Tower of London  software.</prim_outcome>
      <prim_outcome>Attention and Response Inhibition. Timepoint: Before intervention - after intervention and one month following the end of the last intervention sessions. Method of measurement: Complex Stroop software.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before intervention - after intervention and one month following the end of the last intervention sessions. Method of measurement: N-back working memory software.</prim_outcome>
      <prim_outcome>Cognitive Flexibility. Timepoint: Before intervention - after intervention and one month following the end of the last intervention sessions. Method of measurement: Wisconsin Software.</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>The University of Semnan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-17</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan, Basij Boulevard, Central Administration of Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
