<?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>IRCT2014041417270N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-29</date_registration>
      <primary_sponsor>Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of Teach Back educational method and accompanying person on anxiety and vital signs changes in woman candidate for cesarean section</public_title>
      <acronym>-</acronym>
      <scientific_title>The comparison of Teach Back educational method and accompanying person on anxiety and vital signs changes in woman candidate for cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15932</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>surgical anxiety.</hc_freetext>
      <i_freetext>Intervention 1: second intervention group is the Accompanying Person group.In this group, routine training provided by the ward nurse and their partner were allowed to present next to them from the night before the surgery until 15 minutes before starting their surgery in the operating room. Intervention 2: First intervention group is the Teach Back group. In this group individuals were educated by using Teach Back method in this way that after determining training needs, educational program that is approved by the faculty, provided by researcher. In this method, researcher visits the patients at the night before their surgery and educates them face-to-face, in simple and understandable terms without use of special medical training terms in 45-30 minute. After completion of training, the patient were asked to say what they understand, in their own words. If the patient has not understood the content of sessions, educator would continue to explain until the patient would fully understand the contents. this educational program has a regular structure and Is flexible to suit the patient's needs that contains an overview of cesarean section include Reasons for Cesarean delivery, cesarean section maternal care, events are expected in the operating room and so on. To implement the method, face to face training will be used to raise the level of patient knowledge. One hour after training, the patient will be referred for evaluation of feedback and the patient's problems and questions will be answered. The Teach-Back score is set so that if the patient has 75% correct answers to the questions asked, it is considered an effective means of teaching and learning will continue otherwise. Intervention 3: Control group is the third group whom no intervention applyed to them except routine educations.</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>Nasim Hatefi Moadab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Taleghani Hospital Educational Complex, Abadan, Iran</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3424 2764</telephone>
        <email>hatefi.n@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Elahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>-</telephone>
        <email>elahi-n@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 20 to 30 years old, not treated with anxiolytic or sedative drugs during hospitalization, have consent to participate in the study have moderate(41-60) or severe(61-80) anxiety according to the STAI and candidate for the first cesarean section. Exclusion criteria: psychological disorders, hearing loss, and unwillingness to continue participation in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40, F41, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>second intervention group is the Accompanying Person group.In this group, routine training provided by the ward nurse and their partner were allowed to present next to them from the night before the surgery until 15 minutes before starting their surgery in the operating room.</i_keyword>
      <i_keyword>First intervention group is the Teach Back group. In this group individuals were educated by using Teach Back method in this way that after determining training needs, educational program that is approved by the faculty, provided by researcher. In this method, researcher visits the patients at the night before their surgery and educates them face-to-face, in simple and understandable terms without use of special medical training terms in 45-30 minute. After completion of training, the patient were asked to say what they understand, in their own words. If the patient has not understood the content of sessions, educator would continue to explain until the patient would fully understand the contents. this educational program has a regular structure and Is flexible to suit the patient's needs that contains an overview of cesarean section include Reasons for Cesarean delivery, cesarean section maternal care, events are expected in the operating room and so on. To implement the method, face to face training will be used to raise the level of patient knowledge. One hour after training, the patient will be referred for evaluation of feedback and the patient's problems and questions will be answered. The Teach-Back score is set so that if the patient has 75% correct answers to the questions asked, it is considered an effective means of teaching and learning will continue otherwise.</i_keyword>
      <i_keyword>Control group is the third group whom no intervention applyed to them except routine educations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety before surgery. Timepoint: the night beore surgery and the day of the surgery. Method of measurement: Spiel Berger State-Trait Anxiety  inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systole Blood Pressure. Timepoint: Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention). Method of measurement: mmHg- Electronic Manometer(Beurer made in Germany).</sec_outcome>
      <sec_outcome>Diastole Blood Pressure. Timepoint: Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention). Method of measurement: mmHg- Electronic Manometer(Beurer made in Germany).</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention). Method of measurement: Number in minute by using analog clock and numeration.</sec_outcome>
      <sec_outcome>Pulse Rate. Timepoint: Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention). Method of measurement: Number in minute by using analog clock and numeration.</sec_outcome>
      <sec_outcome>Temperature. Timepoint: Night Before The Surgery (Before Intervention)and Day of The Surgery(After Intervention). Method of measurement: Mercury thermometer made in iran.</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 of Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-07</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Ahvaz  Judishapur University of Medical Sciences, Golestan highway, Ahvaz, Iran Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
