<?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>IRCT20220625055272N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-15</date_registration>
      <primary_sponsor>The University of Tehran</primary_sponsor>
      <public_title>Developing and Effectiveness a  family- based  psychological  intervention  program on spiritual happiness, marital satisfaction  and migraine disorder syndrome couples</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy a  family- based  psychological  intervention  program on spiritual happiness, marital satisfaction  and migraine disorder syndrome couples</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64373</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization with random numbers in the group division Randomized allocation in clinical trial studies refers to randomly dividing participants into different groups. Randomizing gives each participant equal odds of being placed in each group. Forty migraine patients are selected randomly in the centers. The randomization tool is a random table of numbers in which the researcher moves the numbers right and downward on one of the numbers,  finally recording the numbers and dividing them into two experimental groups of twenty people and determining the control group (twenty people) whose number has already been established.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Family-centered psychological interventions program by recognizing and respecting the existence of the family and promoting the competence and confidence of the family in taking care of themselves and the patient, and empowering the family to support the patient in the compromise with the care and treatment system, according to the focus of the education of the enhancing lifestyle Health and its maintenance, adherence to treatment, interpersonal communication, stress management and prevention of disease progression were compiled with the participation of the family and with a holistic approach. In the present study, after developing a package of family-oriented psychological interventions, this program was conducted in 8 sessions of 1.5-2 hours per week, with the educational participation of the spouse of the affected person and the affected person, and the transfer of information through educational booklets and audio CDs. ) was done as a group. Intervention 2: Control group: Only taking medication was prescribed by a neurologist.</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:
All related data to participants are shared after hiding patient's name.

When:
The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles.

To whom:
The present study data will be available only to researchers working in the academic and scientific institutions.

Conditions:
The output of statistical analysis will be available

Where to obtain:
Applicants can apply for documentation and data via email at sheikhlinegar34@gmail.com

How to obtain:
After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negar Sheikhli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>پردیس کیش: بلوار میرمهنا - ابتدای خیابان نیایش - پردیس بین المللی کیش دانشگاه تهران</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1358879331</zip>
        <telephone>+98 34 4326 3329</telephone>
        <email>sheikhlinegar34@gmail.com</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Sheikhli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kish Campus: Mirmahna Blvd. - the beginning of Niayesh St. - Kish International Campus of Tehran University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1358879331</zip>
        <telephone>+98 34 4326 3329</telephone>
        <email>sheikhlinegar34@gmail.com</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 40-50 years
The diagnosis of migraine disorders should be confirmed based on the clinical diagnosis of migraine in patients.
Not using other treatment psychotherapy programs and changing medications during the research
Being married
Willingness to cooperate
No substance abuse</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Psychological treatment in the last 6 months
Severe mental disorder Failure to respond to the therapist for two weeks in a row
participants suffering from other physical diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura [common migraine]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Family-centered psychological interventions program by recognizing and respecting the existence of the family and promoting the competence and confidence of the family in taking care of themselves and the patient, and empowering the family to support the patient in the compromise with the care and treatment system, according to the focus of the education of the enhancing lifestyle Health and its maintenance, adherence to treatment, interpersonal communication, stress management and prevention of disease progression were compiled with the participation of the family and with a holistic approach. In the present study, after developing a package of family-oriented psychological interventions, this program was conducted in 8 sessions of 1.5-2 hours per week, with the educational participation of the spouse of the affected person and the affected person, and the transfer of information through educational booklets and audio CDs. ) was done as a group.</i_keyword>
      <i_keyword>Control group: Only taking medication was prescribed by a neurologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain syndrome. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Pain Disability Index Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spiritual vitality. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Spiritual Vitality Scale (Afrooz, 2016).</sec_outcome>
      <sec_outcome>Marital satisfaction. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Marriage Satisfaction Questionnaire.</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 Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-05</approval_date>
        <contact_name>Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Tehran</contact_name>
        <contact_address>Kish Campus: Mirmahna Blvd. - the beginning of Niayesh St. - Kish International Campus of Tehran University Kish Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
