<?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>IRCT20211218053447N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Neurofeedback on Footballists.</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Neurofeedback Training on Competitive Aggressiveness, Emotion Regulation Difficulties and Sport Function in Football Athletes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: At first, Football Athletes are selected according to the inclusion criteria. And then according to the random sequence obtained through Random allocation software, In the same way, Football Athletes will be randomly divided into experimental and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Football Athletes. Condition 2: Competitive Aggressiveness. Condition 3: Emotion Regulation Difficulties. Condition 4: Sport Function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Football Athletes who receive Neurofeedback Training. In relation to therapeutic intervention and data collection, neurofeedback device treatment protocols and tools such as Questionnaires will be used. Each Athletes undergoes neurotherapy for 30 minutes 3 times a week for 2 months in each session. Neurofeedback intervention is performed with monopolar protocol. At the point "FCz" of the head, Theta(4 to 8 Hz) will decrease, Low Beta(16 to 21 Hz) will increase, and High Beta(20 to 32 Hz) will decrease. All Athletes complete the questionnaires before and after the intervention. The questionnaires used in this research are as follows: 1)Competitive Aggression and Anger Scale Test 2)Difficulties in Emotion Regulation Scale Test 3)Sport Performance Scale Test 4)Sports Success Scale Test. Intervention 2: Control group: Football Athletes who do not receive Neurofeedback Training. In relation to data collection, tools such as Questionnaires will be used. Pre-test and post-test are taken from all athletes without therapeutic intervention. The questionnaires used in this research are as follows: 1)Competitive Aggression and Anger Scale Test 2)Difficulties in Emotion Regulation Scale Test 3)Sport Performance Scale Test 4)Sports Success Scale Test.</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:
All data obtained from the results of questionnaires, diagnostic interviews and improving the performance of clients will be published.

When:
Access period starts from September 2022

To whom:
Data and other documents are available to all researchers in the field of research.

Conditions:
If other people request to receive data and documents, send a message to my personal email.

Where to obtain:
Navid Agand is responsible by calling +989115078797 and emailing navid.a0152@gmail.com

How to obtain:
Applicants should call +989115078797 to receive the required documents or data or send an email to navid.a0152@gmail.com  . Documents will be provided to them within 72 hours to a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Agand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Ayatollah Vahid street, Riyahini alley</address>
        <city>Astaneh Ashrafiyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4441953533</zip>
        <telephone>+98 13 4212 0152</telephone>
        <email>navid.a0152@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Agand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Ayatollah Vahid street, Riyahini alley</address>
        <city>Astaneh Ashrafiyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4441953533</zip>
        <telephone>+98 13 4212 0152</telephone>
        <email>navid.a0152@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a registration card in a football club
Being a boy
At least 3 months of continuous training in the club
Being young (age 16-21)</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>21 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having psychological disorders.
Athletes in the youth age range(over 21).
Activities in sports clubs outside the study city.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Football Athletes who receive Neurofeedback Training. In relation to therapeutic intervention and data collection, neurofeedback device treatment protocols and tools such as Questionnaires will be used. Each Athletes undergoes neurotherapy for 30 minutes 3 times a week for 2 months in each session. Neurofeedback intervention is performed with monopolar protocol. At the point "FCz" of the head, Theta(4 to 8 Hz) will decrease, Low Beta(16 to 21 Hz) will increase, and High Beta(20 to 32 Hz) will decrease. All Athletes complete the questionnaires before and after the intervention. The questionnaires used in this research are as follows: 1)Competitive Aggression and Anger Scale Test 2)Difficulties in Emotion Regulation Scale Test 3)Sport Performance Scale Test 4)Sports Success Scale Test</i_keyword>
      <i_keyword>Control group: Football Athletes who do not receive Neurofeedback Training. In relation to data collection, tools such as Questionnaires will be used. Pre-test and post-test are taken from all athletes without therapeutic intervention. The questionnaires used in this research are as follows: 1)Competitive Aggression and Anger Scale Test 2)Difficulties in Emotion Regulation Scale Test 3)Sport Performance Scale Test 4)Sports Success Scale Test</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Competitive Aggression Score in Athletes Competitive Aggression and Anger Scale Test. Timepoint: Measurement of Competitive Aggression at the beginning of the study and 15 sessions after starting Neurotherapy(Neurofeedback training). Method of measurement: Athletes Competitive Aggression and Anger Scale Test(Maxwell &amp; Moores).</prim_outcome>
      <prim_outcome>Difficulties in Emotion  Regulation Score in Difficulties in Emotion  Regulation Scale Test (Gratz &amp; Roemer). Timepoint: Measurement of Difficulties in Emotion  Regulation at the beginning of the study and 15 sessions after starting Neurotherapy(Neurofeedback training). Method of measurement: Difficulties in Emotion  Regulation Scale Test (Gratz &amp; Roemer).</prim_outcome>
      <prim_outcome>Sport Performance Score in Sport Performance Scale Test(Charbonneau) and in Sports Success Scale Test(Moosavi&amp;Vaez). Timepoint: Measurement of Sport Performance at the beginning of the study and 15 sessions after starting Neurotherapy(Neurofeedback training). Method of measurement: Sport Performance Scale Test(Charbonneau) and  Sports Success Scale Test(Moosavi&amp;Vaez).</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>Lahijan Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-15</approval_date>
        <contact_name>Ethics Committee of Lahijan Branch of Azad University</contact_name>
        <contact_address>No. 24, Ayatollah Vahid street, Riyahini alley Astaneh Ashrafiyeh Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
