<?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>IRCT2015010520559N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University Of Medical Science</primary_sponsor>
      <public_title>Education of self care behaviors in patients undergoing  radiotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of using multimedia and pamphlet on anxiety, side effects and self care behaviors of patients undergoing radiotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>head and neck cancers.</hc_freetext>
      <i_freetext>Intervention 1: After a one individual session for the 20 minutes about radiotherapy, local and systematic side effects, the 20 minutes Multimedia will be delivered to the patients or transfer to their mobiles as they want. The patients will be asked to use it before the first session of treatment. This file contents several parts. The first part contents general information about disease and treatments. The second part contents information about radiotherapy and  treatment environment. The third part contents information about possible side effects (sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them. Final part contents an exam with 5 questions about delivered subjects that after specified time for answering ,the responses will be displayed. Most of the designed file containing sounds and images and in some parts texts is used. Intervention 2: In pamphlet group after individual training session, three pamphlets that have same content with multimedia include general information about radiotherapy and  treatment environment, possible side effects (such as sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them will be delivered to the patients and asked them to read the pamphlets before the first session of treatment.</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>Atefeh Behboodifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number82, Modaress 11"St". Vakil abad "Blvd". Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3609 5512</telephone>
        <email>behboudifara1@mums.ac.irAtefehbehboodifar@gmail.com</email>
        <affiliation>Mashhad University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Heshmati Nabavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Doctora Crossroads, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>heshmatinf@mums.ac.ir</email>
        <affiliation>Mashad University Of Medical Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:1-Age between 18 and 65 2-Patient that Singed Consent Knowingly 3-Decisive diagnose for needing radiotherapy by physician 4-Have no chemotherapy in last three months&#13;
 5-Radiotherapy for the first time 6-Head and neck radiotherapy 7-Patient or close family not to be in health group 8-Ability to read and write in patient or main caregivers 9-Enough ability for receiving education 10-Having acceptable visual and hearing ability for receiving education&#13;
Exclusion criteria: 1- Unwillingness to continue cooperation 2-Stressful events during intervention such as divorce, death in close family and losing job 3-Unstable situation in patient that making impossible to continue participate 4-Receiving information from the other sources apart from intervention during the program(for example participate in other education program or classes) 5-Do not use of provided educational content until the first session of treatment.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c00-c14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms of lip, oral cavity and pharynx</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After a one individual session for the 20 minutes about radiotherapy, local and systematic side effects, the 20 minutes Multimedia will be delivered to the patients or transfer to their mobiles as they want. The patients will be asked to use it before the first session of treatment. This file contents several parts. The first part contents general information about disease and treatments. The second part contents information about radiotherapy and  treatment environment. The third part contents information about possible side effects (sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them. Final part contents an exam with 5 questions about delivered subjects that after specified time for answering ,the responses will be displayed. Most of the designed file containing sounds and images and in some parts texts is used.</i_keyword>
      <i_keyword>In pamphlet group after individual training session, three pamphlets that have same content with multimedia include general information about radiotherapy and  treatment environment, possible side effects (such as sleep disorders, loss of appetite, fatigue and mouth dryness), management of these side effects and necessary cares for them will be delivered to the patients and asked them to read the pamphlets before the first session of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention and almost 2 weeks after intervention depending on the time of starting treatment. Method of measurement: Spielberger STAI.</prim_outcome>
      <prim_outcome>Radiotherapy Side Effects. Timepoint: First, third and fifth week after intervention. Method of measurement: Nail's Self Care Diary.</prim_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: First, third and fifth week after intervention. Method of measurement: Nail's Self Care Diary.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of side effects of radiotherapy. Timepoint: First, third and fifth week after interventin. Method of measurement: Nail's Self Care Dairy.</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>Vice chancellor for research, Mashhad University Of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-14</approval_date>
        <contact_name>Ethics committee of Mashhad University Of Medical Science</contact_name>
        <contact_address>Ghoraishy Building, University"St". Mashhad Mshhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
