<?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>IRCT20220530055023N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-18</date_registration>
      <primary_sponsor>The University of Shiraz</primary_sponsor>
      <public_title>The Effectiveness of Mindfulness Self Compassion Program in Migraine</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindfulness Self Compassion Program Training on Severity of Migraine Headache and Quality of Life in Women With Migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63867</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 30 subjects will be chosen from available candidates using convenience sampling method. Subjects will be split randomly between two groups, control group and intervention group, each group containing 15 persons. For randomizing the splitting process, initially an integer codes between 01 and 30 will be assigned to each person, then we move and stop our finger randomly and blindfolded on a RAND Corporation random number table, we move on that chosen row to find the corresponding random number and consider the last two digits of the random number. If the number is between 01 and 30, a successful random number is generated. The process will continue till 15 random integers in the desired interval is made. 15 selected codes are in the intervention group and the rest are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Migraine. Condition 2: Quality of Life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: consisted of 15 female subjects affected with migraine will have weekly group trainings for 8 sessions and each session for two and a half hours long.Training sessions will be held once a week and will last for a total of 2 months. They will continue their medication as prescribed by their physician. Each session has a main topic and a target which will be exercised by discussing more elaborate subtopics and by practicing various trainings. Sessions main topics are: discovering self-compassion, practicing Mindfulness, practicing love-kindness, discovering self-compassionate voice, living deeply, retreating, meeting difficult emotions, exploring challenging relationships, and embracing own life. Examples for the practices are: compassionate listening, forgiveness and embodied listening. During group sessions, the self-compassion basic concepts will be taught to the group by incorporating examples and taking advantage of group training power, and self-compassion will be introduced to the group by using concentration increasing exercises. In the course of sessions, subjects will learn how to be self-compassionate and how to be self-conscious about their feelings and bodily status. Intervention 2: Control group: consisted of 15 female subjects affected with migraine that will not receive any training and continue their medication as prescribed by their physician. They will join pre-test and post-test, before and after intervention respectively.</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:
Data (not including participant personal information) consisted of research protocol, questioner’s raw scores, raw forms, raw consent form and general participation protocols is available for fellow researchers via email application, 6 months after first paper publication.

When:
6 months after the publication of the article

To whom:
Mental health researchers and physical health researchers

Conditions:
Applications: Phycology, chronic headaches, migraine researches

Where to obtain:
Send an email to the  researchers

How to obtain:
Requests for data will be considered by researchers and in case of being applicable to a mental or physical health research, data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Kargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Sarvenaz Building, Khakshenasi Street, Eram Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7143713386</zip>
        <telephone>+98 71 3227 5053</telephone>
        <email>kargar9574@gmail.com</email>
        <affiliation>The University of Shiraz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Changiz Rahimi Taghanaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology and Educational Sciences, Eram University Campus, Eram Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194684334</zip>
        <telephone>+98 71 3613 4662</telephone>
        <email>crahimi2016@hotamail.com</email>
        <affiliation>The University of Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having migraine for at least one year
Must be in 20 to 50 years old range
Educational requirement: must have high school diploma
Interested in participating in phycological researches</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from psychiatric problems
Suffering from physical illnesses that prohibits active participating in group therapy sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: consisted of 15 female subjects affected with migraine will have weekly group trainings for 8 sessions and each session for two and a half hours long.Training sessions will be held once a week and will last for a total of 2 months. They will continue their medication as prescribed by their physician. Each session has a main topic and a target which will be exercised by discussing more elaborate subtopics and by practicing various trainings. Sessions main topics are: discovering self-compassion, practicing Mindfulness, practicing love-kindness, discovering self-compassionate voice, living deeply, retreating, meeting difficult emotions, exploring challenging relationships, and embracing own life. Examples for the practices are: compassionate listening, forgiveness and embodied listening. During group sessions, the self-compassion basic concepts will be taught to the group by incorporating examples and taking advantage of group training power, and self-compassion will be introduced to the group by using concentration increasing exercises. In the course of sessions, subjects will learn how to be self-compassionate and how to be self-conscious about their feelings and bodily status.</i_keyword>
      <i_keyword>Control group: consisted of 15 female subjects affected with migraine that will not receive any training and continue their medication as prescribed by their physician. They will join pre-test and post-test, before and after intervention respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>McGill Pain Questionnaire Score. Timepoint: Before intervention and after intervention. Method of measurement: McGill Pain Questionnaire(MPQ).</prim_outcome>
      <prim_outcome>World Health Organization Quality of Life Questionnaire BREF score. Timepoint: Before intervention and after intervention. Method of measurement: World Health Organization Quality of Life Questionnaire BREF(WHOQOL-BREF).</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>The University of Shiraz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-25</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Seventh floor, Central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
