<?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>IRCT2012121911820N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-18</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences - University of Central Staff - Building No. 4 - Vice Chancel</primary_sponsor>
      <public_title>The effect of psycho-education on caregiver burden</public_title>
      <acronym>multiple sclerosis</acronym>
      <scientific_title>The effect of psycho-education on family caregiver burden with multiple sclerosis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12014</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention is a family group psycho-education based on a scheduled multi-session program with families and main caregivers to consider their needs and problems, and also to study the current articles which are gathered by the researcher, that finally is planned under the supervision of specialists and the lecturers for an educational-supportive intervention for the study group that based on the availability of caregivers there would be six sessions (each session 90 minutes) during six weeks (one week one session). The main caregivers are grouped in minimum 11 to maximum 17 persons which the contents of sessions are same for all groups. The intervention begins with some comments on MS and how it affects the life of patient and the family. Some details regarding the symptoms of MS and disorders which it causes in sensory and motion system and also the effects of these problems on patient and family are expressed. The family will gain some information regarding the potential factors in causing or aggravating of this disease like environmental-familial stresses, ambient temperature, nutrition, physical activities, and also genetics. The role of family communication skills, feeling expressions, coping with negative emotions, reduction of stress and anxiety techniques to caregivers, problem solving techniques, and the utilization of them towards the needs rectification of caregiving roles are provided by providing information for caregivers, which there will be an open discussion by the end of each session. Also, in order to strengthen of learning CDs and educational books are provided which would be the same for control 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Pahlevanzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjerib st., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2960</telephone>
        <email>pahlavanzadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Pahlevanzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjerib st. Darvaze shairaz, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8147673461</zip>
        <telephone>+98 31 1792 2960</telephone>
        <email>pahlavanzadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All family members of MS patients including male and female who refer to neurology clinics and meet the criteria of the study are constructing the sample of the study. The criteria are as follows:&#13;
1.The MS patients with the expanded disability status score (EDSS) of 3-9.5.&#13;
2.Family caregiving is considered as the main support and holds all the responsibilities of the patient.&#13;
3.Interested to participate in the study.&#13;
4. Age more than 18 years old.&#13;
5.Able to communicate and comply with the rules of training sessions.&#13;
6.From each family member who is the main caregiver is participated in the study.&#13;
7.The caregiver is just taking care of one patient refractory in the family.&#13;
8.The duration of patient care is at least 3 months.&#13;
9.Capable of speaking, reading and writing in Farsi.&#13;
10.Have not participated in family education sessions (any research study in this field).&#13;
11.The main caregiver does not under psychotropic medication. &#13;
The criteria of excluding:&#13;
1.The family caregiver is reluctant to cooperate in training sessions.&#13;
2.Existence of any problem that the caregiver is not able to participate in the study.&#13;
3.The caregiver has at most two absents in session records.&#13;
4.There are physical and psychological problems that cannot attend the sessions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>149 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35-G37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention is a family group psycho-education based on a scheduled multi-session program with families and main caregivers to consider their needs and problems, and also to study the current articles which are gathered by the researcher, that finally is planned under the supervision of specialists and the lecturers for an educational-supportive intervention for the study group that based on the availability of caregivers there would be six sessions (each session 90 minutes) during six weeks (one week one session). The main caregivers are grouped in minimum 11 to maximum 17 persons which the contents of sessions are same for all groups. The intervention begins with some comments on MS and how it affects the life of patient and the family. Some details regarding the symptoms of MS and disorders which it causes in sensory and motion system and also the effects of these problems on patient and family are expressed. The family will gain some information regarding the potential factors in causing or aggravating of this disease like environmental-familial stresses, ambient temperature, nutrition, physical activities, and also genetics. The role of family communication skills, feeling expressions, coping with negative emotions, reduction of stress and anxiety techniques to caregivers, problem solving techniques, and the utilization of them towards the needs rectification of caregiving roles are provided by providing information for caregivers, which there will be an open discussion by the end of each session. Also, in order to strengthen of learning CDs and educational books are provided which would be the same for control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Family caregiver burden. Timepoint: Before- immediately and one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress and anxiety of caregivers. Timepoint: Before- immediately and one month after intervention. Method of measurement: 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>Isfahan University of Medical Sciences - University of Central Staff - Building No. 4 - Vice Chancel</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-10</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Darvaze Shiraz, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
