<?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>IRCT20260825070799N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of mindfulness exercises on improving anxiety behaviors and social adaptation</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of mindfulness exercises on improving anxiety behaviors and social adjustment in students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, simple randomization method is used to assign participants to two experimental and control groups. The randomization unit in this study is female high school students in Baghmalek city who are eligible to enter the study. First, a complete list of volunteers who have been selected based on the study entry criteria is prepared. Then, each participant is assigned a unique numerical identification code. These codes are entered into the Random Number Generator software and a random number is generated for each individual. After generating these numbers, the participants are sorted in ascending order based on the value of the random number. Then, the individuals are assigned to two groups; sequentially, the first 15 people on the list are assigned to the experimental group and the next 15 people to the control group. With this method, the order of entry into the study and the researcher's knowledge of the participants will not play any role in determining the group. To ensure allocation concealment, the person responsible for entering data and performing the randomization process in the software will be independent of the intervention administrators and study evaluators and will not have access to information about the session implementation process or changes in the allocation of individuals. Participant identification codes will also be kept confidential and separate from their other personal information. Therefore, it will not be possible to predict the assigned group for each participant before the randomization process, Blinding description: In order to control bias and improve the internal validity of the study, this study was designed with a double-blind protocol; in this way, the intervention implementers, outcome assessor, and data analyst will be kept unaware of the allocation of female students in the first high school of Baghmalek County to the experimental and control groups. In this process, the outcome assessor will collect data in all stages of pre-test, post-test, and follow-up, without knowing the assigned group of the participants, in order to prevent bias in the measurement; also, all raw data will be provided to the statistical analyst with anonymous codes (such as groups 1 and 2), and the true nature of the groups will not be revealed until the end of the data analysis process. All allocation steps will be carried out by an independent person from the research team, and the decoding of the allocation codes will be done only after the final completion of the statistical analyses.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and social problems of students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The AI-based mindfulness training intervention sessions will be based on the treatment protocol designed by Foroughi (1403). The intervention sessions will be conducted in 8 90-minute sessions (one session per week) in a group setting for the experimental group. AI-based mindfulness training is an approach that aims to reduce anxiety-related behaviors and promote social adaptation through intelligent monitoring and interactive exercises, helping students manage their emotions and interpersonal challenges by replacing reactive and automatic patterns with conscious and adaptive responses. This approach has main educational axes that lead to improved emotion regulation and improved communication skills; These axes include: familiarization with the smart system and conscious breathing practice appropriate to the level of anxiety, training in the body scan technique with dynamic feedback, identifying and naming emotions by drawing a weekly emotional pattern, training in conversation skills and conscious listening through interaction with the smart bot, cognitive restructuring and managing negative thoughts with the perspective of a neutral observer, cultivating self-kindness through personalized messages, implementing conscious stopping techniques in real stressful situations with smart reminders, and finally, consolidation, summarizing progress, and presenting a plan. Intervention 2: Control group: hey do not receive any intervention or treatment.</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 Participant data is completely confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roqayeh Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Ayatollah Khamenei Street, Dorahi Eslamabad Village</address>
        <city>Baghmalek</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6395434012</zip>
        <telephone>+98 916 647 3901</telephone>
        <email>Parsakarimimpk@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roqayeh Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Ayatollah Khamenei Street, Dorahi Eslamabad Village</address>
        <city>Baghmalek</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6395434012</zip>
        <telephone>+98 916 647 3901</telephone>
        <email>Parsakarimimpk@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be between at least 12 and at most 15 years old.
Be students of the first secondary education level in Izeh County.
Have informed consent to participate in the research.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a physical illness that causes a disruption in the treatment process.
Consumption of psychiatric medications.</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The AI-based mindfulness training intervention sessions will be based on the treatment protocol designed by Foroughi (1403). The intervention sessions will be conducted in 8 90-minute sessions (one session per week) in a group setting for the experimental group. AI-based mindfulness training is an approach that aims to reduce anxiety-related behaviors and promote social adaptation through intelligent monitoring and interactive exercises, helping students manage their emotions and interpersonal challenges by replacing reactive and automatic patterns with conscious and adaptive responses. This approach has main educational axes that lead to improved emotion regulation and improved communication skills; These axes include: familiarization with the smart system and conscious breathing practice appropriate to the level of anxiety, training in the body scan technique with dynamic feedback, identifying and naming emotions by drawing a weekly emotional pattern, training in conversation skills and conscious listening through interaction with the smart bot, cognitive restructuring and managing negative thoughts with the perspective of a neutral observer, cultivating self-kindness through personalized messages, implementing conscious stopping techniques in real stressful situations with smart reminders, and finally, consolidation, summarizing progress, and presenting a plan.</i_keyword>
      <i_keyword>Control group: hey do not receive any intervention or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxious behaviors. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Ligerka and Stone's Anxiety Behavior Questionnaire (1993).</prim_outcome>
      <prim_outcome>Social adaptation. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Sinha and Singh's Social Adaptation Scale (1993).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-21</approval_date>
        <contact_name>Behbahan Islamic Azad University Ethics Committee</contact_name>
        <contact_address>Shahid Bayani St., Amir Kabir Blvd. Behbahan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
