<?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>IRCT20170512033932N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The influence of education on anxiety and self-efficacy in mothers of children with surgery</public_title>
      <acronym></acronym>
      <scientific_title>The influence of education on anxiety and self-efficacy in mothers of children with surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: A simple randomization is done with sealed envelope tools in such a way that the envelopes are written in letters A and B, and the mothers are asked to select an envelope that the group A of the intervention group and the B group will be tested.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The training is done in eight sections based on the following: the type of disease and type of surgery that will be performed on the child. Familiarization and information about the facilities and personnel providing the facility to the patient and family. Pre-post and post-surgery photographs and examples of similar surgical procedures. Adoption and preparation of the child before surgery, including fasting and feeding, cleaning the surgical site, having routine tests, operating time, satisfaction The practice and the list of possible medications and child allergies, as well as the introduction of the head nurse and the department staff and rotia This section introduces the personnel and nurse of the department, interventions and nursing practices that are implemented during the hospitalization, how to admit to the surgery department and to carry out sterilization and serum therapy, and receive prescription drugs and antibiotics, the presentation of a pamphlet about the disease, coordinating with the operating room in the presence of the mother, answering the mother's questions about the time and procedure, attending the mother at the time of the child's admission in the operating room, familiarizing the mother with the surgery team and the anesthetist on the duration of the operation, encouraging the mother to express her feelings, Postoperative postoperative postoperative pain training, postoperative pain control, surgical warnings, diet, mobility, and f Child's excellence, timing of discharge and educational explanations, and answering mothers' questions. Presenting pamphlets on training, post-clearance training, follow-up and post-visit follow-up, and how to use medications. Intervention 2: Control group: In the control group, routine training is given during admission and admission and before surgery.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I am planning and drafting a paper for it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hosein Motahari Niya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no.28 Ave, Golshar Blvd,</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916845118</zip>
        <telephone>+98 17 3212 8035</telephone>
        <email>hoseinmotahari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Hojati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azad University Ave , Azad University</address>
        <city>Aliabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3422 4500</telephone>
        <email>h_hojjati1392@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers who used surgery for the first time in their child</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A history of abortion
Has a lack of speech and understanding of Persian language
Inability to take care of yourself and the child
Physical and mental illness
Illiteracy, reading and writing, and having a child undergoing general surgery)Mothers whose children had physical and psychological problems (mental retardation, cerebral palsy, and congenital chronic defects)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F41.9</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The training is done in eight sections based on the following: the type of disease and type of surgery that will be performed on the child. Familiarization and information about the facilities and personnel providing the facility to the patient and family. Pre-post and post-surgery photographs and examples of similar surgical procedures. Adoption and preparation of the child before surgery, including fasting and feeding, cleaning the surgical site, having routine tests, operating time, satisfaction The practice and the list of possible medications and child allergies, as well as the introduction of the head nurse and the department staff and rotia This section introduces the personnel and nurse of the department, interventions and nursing practices that are implemented during the hospitalization, how to admit to the surgery department and to carry out sterilization and serum therapy, and receive prescription drugs and antibiotics, the presentation of a pamphlet about the disease, coordinating with the operating room in the presence of the mother, answering the mother's questions about the time and procedure, attending the mother at the time of the child's admission in the operating room, familiarizing the mother with the surgery team and the anesthetist on the duration of the operation, encouraging the mother to express her feelings, Postoperative postoperative postoperative pain training, postoperative pain control, surgical warnings, diet, mobility, and f Child's excellence, timing of discharge and educational explanations, and answering mothers' questions. Presenting pamphlets on training, post-clearance training, follow-up and post-visit follow-up, and how to use medications</i_keyword>
      <i_keyword>Control group: In the control group, routine training is given during admission and admission and before surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Scale from the Spielberger Anxiety Inventory. Timepoint: Before the intervention begins and after intervention(STAI). Method of measurement: Based on total score of anxiety.</prim_outcome>
      <prim_outcome>Self-efficacy scores from the Dumika questionnaire(PSAM). Timepoint: Before the intervention begins and after intervention. Method of measurement: Based on total score of self-efficacy.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-23</approval_date>
        <contact_name>کمیته اخلاق در پژوهش های زیست پزشکی دانشگاه آزاد واحد چالوس</contact_name>
        <contact_address>چالوس دانشگاه آزاد اسلامی واحد چالوس Chalus Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
