<?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>IRCT20260508069294N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Mindfulness on Competitive Anxiety and Physiological Indices</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindfulness Training on Competitive Anxiety and Related Physiological Indices in Martial Arts Athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92662</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants (30 Ninjutsu athletes) will be allocated to either the intervention (n=15) or control group (n=15) in a 1:1 ratio using a permuted block randomization method with block sizes of 4 and 6. The random allocation sequence will be generated using the online Research Randomizer tool (www.randomizer.org). To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) will be utilized; group allocation cards will be placed inside the envelopes and opened by an individual independent of the research team only after obtaining written informed consent and completing baseline assessments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Competitive anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive an 8-week Mindfulness-Based Stress Reduction program consisting of weekly 90-minute group sessions along with 45 minutes of daily home practice. The session contents are as follows: Session 1: Introduction to MBSR, ground rules, mindful eating, body scan, and awareness of daily activities; Session 2: Homework review, body scan, mindful breathing, and pleasant events calendar; Session 3: Review of practices, mindful stretching and movement, gentle mindful yoga, exploring boundaries of discomfort/pain, mindful walking, and breath awareness; Session 4: Sitting meditation (body, breath, and sounds), walking meditation, and unpleasant events calendar; Session 5: Sitting meditation with open awareness (working with difficulties), mindful yoga, reactive pattern awareness, and coping breathing space; Session 6: Day of silent practice, integrating body scan, yoga, meditation on thoughts, and developing an early warning system; Session 7: Sustained mindfulness practice, advanced sitting meditation, mindfulness in relationships, daily life integration, and 3-minute breathing space; Session 8: Review of learned skills, developing a personalized daily maintenance plan, and program termination. Intervention 2: Control group: Participants in the control group will not receive any psychological intervention or mindfulness training during the study period and will only continue their routine athletic 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 additional information is available. The final decision regarding data sharing will be made after study completion in accordance with ethical guidelines.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parham Kazemkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Corner of East Yas 1 Alley, Salomeh (Salomahalleh), Valiasr St., Hasansara</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4484118973</zip>
        <telephone>+98 13 4261 5566</telephone>
        <email>senseiparhamkazemkhah@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parham Kazemkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Corner of East Yas 1 Alley, Salomeh (Salomahalleh), Valiasr St., Hasansara</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4484118973</zip>
        <telephone>+98 13 4261 5566</telephone>
        <email>senseiparhamkazemkhah@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at Least one Year of Professional Training Experience in Ninjutsu Martial Arts
Completion of The Martens Competitive State Anxiety Inventory-Revised(CSAl-2R) and Baseline Physiological Assessments at the Pre-test Stage</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Prior Participation in Mindfulness Training Workshops or Courses
History of Hospitalization Due to Severe Psychiatric Disorders</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: Participants in the intervention group will receive an 8-week Mindfulness-Based Stress Reduction program consisting of weekly 90-minute group sessions along with 45 minutes of daily home practice. The session contents are as follows: Session 1: Introduction to MBSR, ground rules, mindful eating, body scan, and awareness of daily activities; Session 2: Homework review, body scan, mindful breathing, and pleasant events calendar; Session 3: Review of practices, mindful stretching and movement, gentle mindful yoga, exploring boundaries of discomfort/pain, mindful walking, and breath awareness; Session 4: Sitting meditation (body, breath, and sounds), walking meditation, and unpleasant events calendar; Session 5: Sitting meditation with open awareness (working with difficulties), mindful yoga, reactive pattern awareness, and coping breathing space; Session 6: Day of silent practice, integrating body scan, yoga, meditation on thoughts, and developing an early warning system; Session 7: Sustained mindfulness practice, advanced sitting meditation, mindfulness in relationships, daily life integration, and 3-minute breathing space; Session 8: Review of learned skills, developing a personalized daily maintenance plan, and program termination.</i_keyword>
      <i_keyword>Control group: Participants in the control group will not receive any psychological intervention or mindfulness training during the study period and will only continue their routine athletic training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Competitive anxiety score measured using the Revised Competitive State Anxiety Inventory-2 (CSAI-2R). Timepoint: At baseline (prior to the intervention) and immediately after the 8-week intervention. Method of measurement: Competitive anxiety will be assessed using the Revised Competitive State Anxiety Inventory-2 (CSAI-2R), a validated self-report questionnaire consisting of 17 items that measure cognitive anxiety, somatic anxiety, and self-confidence.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum cortisol level will be measured in micrograms per deciliter (µg/dL). Timepoint: At baseline (prior to the intervention) and immediately after the completion of the 8-week intervention. Method of measurement: Serum cortisol will be measured via 5 mL venous blood sampling analyzed using the ELISA method, conducted between 08:00 and 10:00 AM to control for diurnal variation.</sec_outcome>
      <sec_outcome>Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg). Timepoint: At baseline (prior to the intervention) and immediately after the completion of the 8-week intervention. Method of measurement: Systolic and diastolic blood pressure will be measured using a calibrated digital blood pressure monitor (GLAMOR TD-3128) in a seated position following a 5-minute rest, with consistent conditions at each assessment.</sec_outcome>
      <sec_outcome>Heart rate measured in beats per minute (bpm). Timepoint: At baseline (prior to the intervention) and at the end of the 8th week (following the completion of the intervention). Method of measurement: Heart rate will be measured using a calibrated digital blood pressure monitor (GLAMOR TD-3128) in a seated position following a 5-minute rest, with consistent conditions at each assessment.</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>2026-07-15</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Tonekabon Branch</contact_name>
        <contact_address>Islamic Azad University, Tonekabon Branch, Valiabad, 3rd km of Chalous Road, Tonekabon, Mazandaran Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
