<?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>IRCT2017050913092N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-10</date_registration>
      <primary_sponsor>Reserch assistence of Bushehr University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Self Management Empowerment Model on sense of coherence and Self Efficacy Adolescent Injured Motorcyclists</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Self Management Empowerment Model on sense of coherence and Self Efficacy Adolescent Injured Motorcyclists</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13029</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>motor accident.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group,the approaches of empowerment in adolescent injured motorcyclists in two areas sense of coherence and self efficacy, according to self-managed empowerment pattern in  five steps will heldfor. So that the approaches   according to the need and situation of injured adolescents, at least In two 45-minute sessions will be taught to the teen and then the training pamphlets will be provided to them. Intervention 2: After receiving a written consent from all the participents and completing demographic questioner, Antonowsky's questioner about the sense of solidarity will be distributed.&#13;
In the intervention group, the intervention is in the form of empowering adolescent in the management of post conditions of motor accidents and increasing the efficiency of their daily life.&#13;
It will be conducted in the form of individual interviews for two weeks and it will be continued for two months.&#13;
The self management empowering program in cluding such structural concepts as self awareness of changes, independence, role function, compatibility, percieved satisfaction, sense of control and self management will be taught to adolescents in the intervention group. Intervention 3: After receiving a written consent from all the participents and completing demographic questioner, Antonowsky's questioner about the sense of coherence  and self - efficasy Scherrer's  questionnaire  will be distributed.In control group,No intervention does not take place after two months, questionnaires Ntvnvvsky sense of coherence and self - efficasy Scherrer's  questionnaire will be completed by the intervention and control groups.</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>parisa navabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>busher,sabzabad,next salman farsi hospital, Bushehr University of Medical Sciences</address>
        <city>busher</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7481865491</zip>
        <telephone>+98 71 5352 3707</telephone>
        <email>pa.navabi@gmail.com</email>
        <affiliation>Research Committee  Bushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>doctor maryam ravanipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>busher,sabzabad,next salman farsi hospital, Bushehr University of Medical Sciences</address>
        <city>busher</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>ravanipour@bpums.ac.ir</email>
        <affiliation>Research Committee Bushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
-	Adolescents aging between 12 and 18&#13;
-	Having a motor accident as a motorcyclist within the past year&#13;
-	Having no diagnosed psychological disease according to the adolescent himself&#13;
-	Having no diagnosed chronic disease&#13;
-	Ability to complete questionnaire &#13;
-	Ability to understand and speak&#13;
-	Having no cognitive and debilitating disease&#13;
-	Using no Psychiatric drug affecting the individual’s speech and behavior&#13;
-	Receiving the consent of adolescent and one of his parents for participation in the study&#13;
&#13;
&#13;
Exclusion criteria:&#13;
-	Participation in other similar studies&#13;
-	Immigration to another city&#13;
-	Lack of any follow ups during the study&#13;
-	The adolescent’s unwillingness to continue the study&#13;
-	The death of participating adolescents in the study</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S30-S39 In</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>S00-S09 Injuries to the head   	 	   	S10-S19 Injuries to the neck   	 	   	S20-S29 Injuries to the thorax   	 	   	S30-S39 Injuries to the abdomen, lower back, lumbar spine and pelvis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group,the approaches of empowerment in adolescent injured motorcyclists in two areas sense of coherence and self efficacy, according to self-managed empowerment pattern in  five steps will heldfor. So that the approaches   according to the need and situation of injured adolescents, at least In two 45-minute sessions will be taught to the teen and then the training pamphlets will be provided to them.</i_keyword>
      <i_keyword>After receiving a written consent from all the participents and completing demographic questioner, Antonowsky's questioner about the sense of solidarity will be distributed.&#13;
In the intervention group, the intervention is in the form of empowering adolescent in the management of post conditions of motor accidents and increasing the efficiency of their daily life.&#13;
It will be conducted in the form of individual interviews for two weeks and it will be continued for two months.&#13;
The self management empowering program in cluding such structural concepts as self awareness of changes, independence, role function, compatibility, percieved satisfaction, sense of control and self management will be taught to adolescents in the intervention group</i_keyword>
      <i_keyword>After receiving a written consent from all the participents and completing demographic questioner, Antonowsky's questioner about the sense of coherence  and self - efficasy Scherrer's  questionnaire  will be distributed.In control group,No intervention does not take place after two months, questionnaires Ntvnvvsky sense of coherence and self - efficasy Scherrer's  questionnaire will be completed by the intervention and control groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attainment to sense of coherence. Timepoint: Before intervention، 2 month after intervention. Method of measurement: Sense of Coherence Antonowsky's Questioner ,.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attainment to  Self Efficacy. Timepoint: before intervention، 2 month after intervention. Method of measurement: Efficacy Questionnaire Scherer.</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>Reserch assistence of Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-19</approval_date>
        <contact_name>Resercher assistence Bushehr University of Medical Sciences</contact_name>
        <contact_address>busher,sabzabad,next salman farsi hospital, Bushehr University of Medical Sciences busher  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
