<?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>IRCT20180914041036N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care education on self-concept and self-efficacy in patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care education on self-concept and self-efficacy in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34064</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, simple randomization method is used with random number table. In the way that the patient enters the groups of the study by selecting one number of the table (the odd numbers for the control group and the even numbers for the intervention group). The study was single blind clinical trial, that means the sampler is unaware of how people are assigned to the groups, Blinding description: Placing people in the intervention and control group using the random numbers table was performed by someone else (not the investigator).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At the beginning of the study, demographic information questionnaire, Rogers self-concept questionnaire, and Sherer's self-efficacy questionnaire (GSES) were completed.                 Self-care education was conducted in five sessions of two hours during eight weeks in group and face-to-face with content of : 1.Prevention of intestinal and bladder disorders include bladder training, doing pelvic muscle exercises, urination and stool management training using Valsalva maneuver, having appropriate diet to prevent constipation, doing exercise and having adequate mobility and drinking adequate fluid, 2.Prevention of impaired mobility, weakness and muscle cramp and imbalance include relaxation and coordination exercises, how to use auxiliary equipment and  hot water shower, 3.Fatigue prevention includes having a regular, tolerable and athletic sport planning, prioritizing tasks, energy conservation and designing the living environment  appropriately, 4.Psychological care education included methods for increasing self-confidence, proper relationship with family and relatives, increasing the hope and encouraging participation in social activities. Intervention 2: Control group: No program was implemented by the researcher for the control group and they followed the regular program of the Iranian Multiple Sclerosis Society.</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:
After defending the thesis and approval by the Tehran University of Medical Sciences, the data collected will be provided to Researchers and patients fully (after unidentification of the participants).

When:
6 months after printing results

To whom:
Information will be provided to researchers and patients

Conditions:
The data will be available to researchers and patients with the aim of improving the quality of life of patients with multiple sclerosis.

Where to obtain:
TEL:
00989181280911
E.mail:
www.ms-sholehvar@razi.tums.ac.ir

How to obtain:
If collecting data is needed, the applicant can express his request by sending an email to the researcher .The researcher will respond to his request within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad saber Sholehvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat st. Tohid sq. Tehran I.IRAN 141973317</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417743855</zip>
        <telephone>+98 83 4322 3496</telephone>
        <email>www.ms-sholehvar@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad saber Sholehvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat st. Tohid sq. Tehran I.IRAN 141973317</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417743855</zip>
        <telephone>+98 83 4322 3496</telephone>
        <email>www.ms-sholehvar@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 20 to 65 years
Not being in the acute phase of multiple sclerosis
Not having another disabling disease
Not being a member of the medical and paramedical staff
Literacy reading and writing</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from progressive-relapsing multiple sclerosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At the beginning of the study, demographic information questionnaire, Rogers self-concept questionnaire, and Sherer's self-efficacy questionnaire (GSES) were completed.                 Self-care education was conducted in five sessions of two hours during eight weeks in group and face-to-face with content of : 1.Prevention of intestinal and bladder disorders include bladder training, doing pelvic muscle exercises, urination and stool management training using Valsalva maneuver, having appropriate diet to prevent constipation, doing exercise and having adequate mobility and drinking adequate fluid, 2.Prevention of impaired mobility, weakness and muscle cramp and imbalance include relaxation and coordination exercises, how to use auxiliary equipment and  hot water shower, 3.Fatigue prevention includes having a regular, tolerable and athletic sport planning, prioritizing tasks, energy conservation and designing the living environment  appropriately, 4.Psychological care education included methods for increasing self-confidence, proper relationship with family and relatives, increasing the hope and encouraging participation in social activities.</i_keyword>
      <i_keyword>Control group: No program was implemented by the researcher for the control group and they followed the regular program of the Iranian Multiple Sclerosis Society.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-concept in patients with multiple sclerosis. Timepoint: Before beginning the study and 8 weeks after training. Method of measurement: Rogers self-concept questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy in patients with multiple sclerosis. Timepoint: Before beginning the study and 8 weeks after training. Method of measurement: Sherer General Self-efficacy 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-02</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Department of Research and Technology,Central Organization of Tehran University of Medical Sciences,Ghods St.Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
