<?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>IRCT20221218056852N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-19</date_registration>
      <primary_sponsor>Nasser Khosrow Saveh non-profit higher education institute</primary_sponsor>
      <public_title>The  effectiveness of cognitive therapy based on mindfulnessamong  on women with migraine.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive therapy based on mindfulness on the cognitive regulation of emotions, severity of migraine psychosomatic symptoms and stress coping styles among women with migraine.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The method of this research is semi-experimental (pre-test - post-test with control group).                                                                                                 period. Research design                                                                                           experiment 16   pre-test                   X                       post-test                                                                                           Control        16   pre-test                    -                       post-test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Cognitive therapy sessions based on mindfulness were conducted for 8 sessions of 45 minutes. The first session: introduction of the participants and a brief description of the 8 sessions of the raisin eating technique, followed by body scan meditation for 30 minutes. Homework: presence in the moment and expansion. Giving the raisin eating technique to other activities, doing body scan meditation and discussing it. The second session: Homework review, the difference between thoughts and feelings. Do meditation. Task: Mindfulness of a pleasant event, doing sitting meditation and body scan, exercise of seeing and hearing, sitting meditation, third session: discussing homework, doing one of the exercises of mindful movements. Homework: sitting meditation, body scan, exercise 3 One minute breathing space. Fourth session: sitting meditation with attention to breathing, discussion about stress responses and a person's reaction to difficult situations.Practicing mindful walking. Assignments: sitting meditation, body scan or one of the body movements of the conscious mind and 3-minute breathing space practice (in an unpleasant event). Sitting meditation. Fifth session: presenting and performing the movements of the conscious mind. Assignments: sitting meditation, breathing space Three minutes in an unpleasant event and mindfulness of a new daily activity. Three-minute breathing space exercise. Sixth session: Discussion about homework. Presenting an exercise with the title of creating, thinking, separate views. Accepting feelings as feelings. Assignments: Choose a combination of meditations of personal preference plus practice a three-minute breathing space on an unpleasant event and mindfulness of a new daily activity. Seventh session: four-dimensional meditation. Practice session: What is the best way to take care of myself?Teaching acceptance without judgment. Assignments: meditation, three-minute breathing exercise in an unpleasant event, mindfulness of a new daily activity. Eighth session: body scan. Three-minute breathing space exercise. Discussing the methods of dealing with the obstacles of doing meditation. Asking questions about the entire session. Intervention 2: Control group: 32 people who referred to the office of neurologists were voluntarily and available, whose migraine questionnaire score was above 25, and two questionnaires on cognitive regulation of emotion and coping styles were also implemented on them, then they were randomly divided into two groups of 16 people, and no intervention It was not done on the control group, and then a post-test was taken with the experimental group.</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:
In this research, the data was analyzed at two descriptive and inferential levels. So that in the descriptive part, the frequency, percentage, mean and standard deviation of the findings were displayed, and in the inferential level, the Kolmograf-Smirnov test was first used to check the normality of the research variables, then the research hypotheses. It was analyzed using the statistical method of multivariate analysis of covariance and univariate covariance analysis in the text of multivariate covariance analysis and SPSS version 23 software.

When:
Unlimited time

To whom:
Organizations and licensed professionals

Conditions:
According to the needs of the applicant

Where to obtain:
Ameneh Shahverdi

How to obtain:
Written request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ameneh Shahverdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 41, Pakmehr Alley, 34, Tayyab St., Imam Hossein Square</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6818884489</zip>
        <telephone>+98 66 3340 9327</telephone>
        <email>montazere74@gmail.com</email>
        <affiliation>Nasser Khosrow Saveh Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mabod Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nur Ali Beyk</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3931133411</zip>
        <telephone>+98 86 4247 8001</telephone>
        <email>maboud_omidi@yahoo.com</email>
        <affiliation>Nasser Khosrow Saveh non-profit higher education institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- The age range of women suffering from migraine disease should be from 20 to 50 years
2- Women suffering from migraine should express their consent to participate in the research.
3- Women with migraine do not have a history of suffering from a mental disorder diagnosed by a psychologist or psychiatrist, or a history of addiction to drugs and alcohol.
4- Women with migraine do not have a history of receiving treatment from a psychotherapist</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- Using drugs, alcohol, or suffering from a diagnosed mental disorder
2- Declaring dissatisfaction with participation in intervention courses
3- Defects in pre-test questionnaires
4- Absence of more than 1 session in the intervention sessions and defects in the post-test questionnaires</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>Cognitive therapy sessions based on mindfulness were conducted for 8 sessions of 45 minutes. The first session: introduction of the participants and a brief description of the 8 sessions of the raisin eating technique, followed by body scan meditation for 30 minutes. Homework: presence in the moment and expansion. Giving the raisin eating technique to other activities, doing body scan meditation and discussing it. The second session: Homework review, the difference between thoughts and feelings. Do meditation. Task: Mindfulness of a pleasant event, doing sitting meditation and body scan, exercise of seeing and hearing, sitting meditation, third session: discussing homework, doing one of the exercises of mindful movements. Homework: sitting meditation, body scan, exercise 3 One minute breathing space. Fourth session: sitting meditation with attention to breathing, discussion about stress responses and a person's reaction to difficult situations.Practicing mindful walking. Assignments: sitting meditation, body scan or one of the body movements of the conscious mind and 3-minute breathing space practice (in an unpleasant event). Sitting meditation. Fifth session: presenting and performing the movements of the conscious mind. Assignments: sitting meditation, breathing space Three minutes in an unpleasant event and mindfulness of a new daily activity. Three-minute breathing space exercise. Sixth session: Discussion about homework. Presenting an exercise with the title of creating, thinking, separate views. Accepting feelings as feelings. Assignments: Choose a combination of meditations of personal preference plus practice a three-minute breathing space on an unpleasant event and mindfulness of a new daily activity. Seventh session: four-dimensional meditation. Practice session: What is the best way to take care of myself?Teaching acceptance without judgment. Assignments: meditation, three-minute breathing exercise in an unpleasant event, mindfulness of a new daily activity. Eighth session: body scan. Three-minute breathing space exercise. Discussing the methods of dealing with the obstacles of doing meditation. Asking questions about the entire session.</i_keyword>
      <i_keyword>Control group: 32 people who referred to the office of neurologists were voluntarily and available, whose migraine questionnaire score was above 25, and two questionnaires on cognitive regulation of emotion and coping styles were also implemented on them, then they were randomly divided into two groups of 16 people, and no intervention It was not done on the control group, and then a post-test was taken with the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people who have a psychosomatic migraine symptom severity questionnaire score above 25. Timepoint: Conducting a pre-test before the implementation of the intervention and a post-test review after two months (8 sessions) that the implementation of the intervention takes.November 21 to January 20. Method of measurement: Questionnaire of severity of psychosomatic symptoms of migraine Najarian (1376).</prim_outcome>
      <prim_outcome>Cognitive emotion regulation questionnaire score. Timepoint: Questionnaire of severity of psychosomatic symptoms of migraine Najarian (1376). Method of measurement: Garnevsky's Cognitive Emotion Regulation Questionnaire (2001).</prim_outcome>
      <prim_outcome>Score of stress coping styles questionnaire. Timepoint: Conducting a pre-test before the implementation of the intervention and a post-test review after two months (8 sessions) that the implementation of the intervention takes. November 21 to January 20. Method of measurement: Billings and Moss (1981) stress coping styles questionnaire.</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>student</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-22</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Pardis Kamalvand Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
