<?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>IRCT20250517065776N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-31</date_registration>
      <primary_sponsor>Persian Gulf University, Bushehr</primary_sponsor>
      <public_title>Mindfulness training based on virtual reality and comparing its effectiveness with mindfulness therapy on attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Mindfulness training based on virtual reality and comparing its effectiveness with mindfulness therapy on the main symptoms, emotional dysregulation and executive functions of male adolescents with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A cluster (a high school) was randomly selected from among the high schools in Karaj. Then, all the students of this high school were considered as a cluster and the SNAP questionnaire was distributed among the students. Students whose average SNAP questionnaire scores were higher than the total average plus one standard deviation were selected as research subjects. These subjects included 65 people. Then, these subjects were randomly assigned to three groups in such a way that each person was assigned an identification code. Then, using random number generation software and the block randomization method, the subjects were divided into three groups: the first experimental group including mindfulness with virtual reality (25 people), the second experiment including traditional mindfulness (25 people), and the control group (15 people). The randomization process was carried out by an independent researcher, and the group assignment will remain secret until the intervention begins to prevent bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention deficit hyperactivity disorder (ADHD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group will receive 8 sessions of mindfulness training using virtual reality, one session per week. In this study, mindfulness exercises will be designed based on the book Mindfulness Prescription for Adults (Attention Deficit Hyperactivity Disorder) and in the virtual reality space. This book consists of 8 steps, and each step includes exercises that aim to improve the problems of people with attention deficit/hyperactivity disorder. Intervention 2: Intervention group: Second intervention: They will receive 8 mindfulness training sessions, one session per week. In this study, mindfulness exercises are based on the book Mindfulness Prescription for Adults (Attention Deficit Hyperactivity Disorder). This book consists of 8 steps, and each step includes exercises that aim to improve the problems of people with attention deficit/hyperactivity disorder. Intervention 3: Control group: They do not receive any 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>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 available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Parsapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.10,maziyar shargi Ave .,baharestan blvd., jahanshahr., karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143833738</zip>
        <telephone>+98 933 738 7640</telephone>
        <email>f.parsapour@mehr.pgu.ac.ir</email>
        <affiliation>Khalije fars university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yusef Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.10,maziyar shargi Ave .,baharestan blvd., jahanshahr., karaj</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516913817</zip>
        <telephone>+98 917 310 6743</telephone>
        <email>ydehghani@pgu.ac.ir</email>
        <affiliation>Khalije fars university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of attention deficit hyperactivity disorder symptoms since childhood
Having normal vision and no serious vision problems
Age between 13 and 18 years old
Absence of neurological disorders such as epilepsy or brain injuries
Parental consent for their child to participate in the study
Failure to receive concurrent treatment (medication and other psychological treatment)</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Inability to use a virtual reality headset</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention deficit: disorder with hyperactivity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group will receive 8 sessions of mindfulness training using virtual reality, one session per week. In this study, mindfulness exercises will be designed based on the book Mindfulness Prescription for Adults (Attention Deficit Hyperactivity Disorder) and in the virtual reality space. This book consists of 8 steps, and each step includes exercises that aim to improve the problems of people with attention deficit/hyperactivity disorder.</i_keyword>
      <i_keyword>Intervention group: Second intervention: They will receive 8 mindfulness training sessions, one session per week. In this study, mindfulness exercises are based on the book Mindfulness Prescription for Adults (Attention Deficit Hyperactivity Disorder). This book consists of 8 steps, and each step includes exercises that aim to improve the problems of people with attention deficit/hyperactivity disorder.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attention Deficit and Hyperactivity-Impulsivity. Timepoint: Pre-test - post-test - after two months. Method of measurement: SNAP questionnaire.</prim_outcome>
      <prim_outcome>Emotion dysregulation. Timepoint: Pre-test - Post-test - After two months. Method of measurement: Gratz and Romer's Difficulty in Emotion Regulation Scale Questionnaire.</prim_outcome>
      <prim_outcome>Executive function. Timepoint: Pre-test - post-test - after two months. Method of measurement: Executive Functions Questionnaire Brief.</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>Persian Gulf University, Bushehr</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-27</approval_date>
        <contact_name>Ethics committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr University of Medical Sciences and Health Services, opposite the Friday prayer place, Moallem Street, Bushehr. Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
