<?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>IRCT20250624066248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Mindfulness-based stress reduction treatment for women with migraine headaches.</public_title>
      <acronym></acronym>
      <scientific_title>A Study the effectiveness of mindfulness-based stress reduction treatment on anxiety sensitivity, rumination, cognitive avoidance and emotional resilience in women with neurogenic migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, participant allocation to study groups was performed using block randomization. The block size was set at block size, 4 participants. To ensure a balanced distribution of participants based on [key characteristic, e.g., migraine severity], stratified randomization was also employed. The unit of randomization was individual. The allocation sequence was generated using statistical software SPSS , and the allocation process was concealed via [concealment method.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Nervous migraine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness-Based Stress Reduction Therapy: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. In this design, the subjects were measured before the implementation of the independent variable (pre-test), then the experimental intervention or independent variable was applied. After that, the subjects were measured again. Finally, after one month of the post-test, both groups were measured again to examine the continuity of the effects of the interventions on the experimental group. In the present study, mindfulness-based stress reduction training sessions were implemented based on the Kabat-Zinn protocol (2013) and were implemented over an 8-week period with 90-minute sessions per week for the experimental group. Intervention 2: Control group: The control group did not receive any intervention during the study. However, to avoid factors that threatened the internal validity of the study, such as compensatory competition by the control group or demoralization, they were assured that they would receive mindfulness-based stress reduction therapy at the next visit (after data collection).</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 Due to the lack of writing the article, which is one of the main conditions for publishing the data, and the extremely busy schedule, the exact time for publishing the data is not yet known. If it is known, action will be taken as soon as possible.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Meli rah</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6374135479</zip>
        <telephone>+98 61 5262 2200</telephone>
        <email>akramhosseiny67@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sasan Bavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz - Pasdaran Boulevard - Airport Road - Islamic Azad University, Khuzestan Science and Research Branch</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۷۷۸۹۳۸۵۵</zip>
        <telephone>+98 916 607 5133</telephone>
        <email>sasanbavi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of women with migraines: 20 to 50 years
History of headaches for at least the past 6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Concurrent participation in other psychological treatments
Having illnesses such as substance abuse and psychotic disorder
Unwillingness to participate in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness-Based Stress Reduction Therapy: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. In this design, the subjects were measured before the implementation of the independent variable (pre-test), then the experimental intervention or independent variable was applied. After that, the subjects were measured again. Finally, after one month of the post-test, both groups were measured again to examine the continuity of the effects of the interventions on the experimental group. In the present study, mindfulness-based stress reduction training sessions were implemented based on the Kabat-Zinn protocol (2013) and were implemented over an 8-week period with 90-minute sessions per week for the experimental group.</i_keyword>
      <i_keyword>Control group: The control group did not receive any intervention during the study. However, to avoid factors that threatened the internal validity of the study, such as compensatory competition by the control group or demoralization, they were assured that they would receive mindfulness-based stress reduction therapy at the next visit (after data collection).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mindfulness-based stress reduction in women with migraine. Timepoint: 30. Method of measurement: Kabat-Zinn Method (2013).</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>2025-01-15</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz Branch</contact_name>
        <contact_address>Golestan-Islamic Azad University of Ahvaz AHVAZ Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
