<?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>IRCT2015082223704N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Dezfoul University of Medical Sciences</primary_sponsor>
      <public_title>Impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances.</public_title>
      <acronym></acronym>
      <scientific_title>Impact of pictorial and movable story book on preoperative anxiety and postoperative behavioral disturbances among hostopitalized 4 - 8 year-old Children with tonsillectomy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Situational anxiety and behavioral disturbances. Condition 2: Situational anxiety and behavioral disturbances.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the story book will be read For 30 minutes on the night before surgery. The researcher would fill the anxiety and the behavioral disorders questionnaire before and after surgery and 10 days after through a phone call with the child's mother. This story will be designed in four parts. Part I: Presentation of information. In this section, two types of information would be given to children. Information regarding procedures includes basic information about the surgery and everything from the entry to exit from the hospital and sensory information includes feelings such as pain, itching, burning, pain in the region of the cut, and nausea and numbness that can be experienced during the treatment would be told to the child. Part II: Behavioral guidelines. In this section, effective behaviors such as breathing before the start of anesthesia would be told to the child and they would be playing the roles. And the child would be asked to repeat them. Part III: Cognitive interventions. In this part of the story book, the researcher would show images of the operating room along with all the equipment used in operating rooms to the child and this will change the child's recognition of the fact that these instruments will be painful. After telling the story for the child, he will be asked to do the works and tell his parents about them in order to review them in his mind. Part IV: Emotional interventions. In the entire process in this story book, the child would be asked to express his feelings and emotions such as anxiety or fear clearly. The child may tell us which part or parts make him frightened more or what he is anxious about. Intervention 2: Control group:  Only routine will be performed. In order to avoid any bias, the anxiety questionnaire would be filled before and after surgery and ten days after intervention of the assessment group including child's clinical psychologist, a nurse and the researcher in this section. Then the researcher would review the child's behavioral disorder through a self-made questionnaire before surgery and ten days after surgery by a phone calling talking to the child's mother.</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>Seyedeh Maryam Molayi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan Blvd, Dezfoul University of Medical Science, Research Center</address>
        <city>Dezfoul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64611-58119</zip>
        <telephone>+98 61 4242 9731</telephone>
        <email>Reaserch@dums.ac.ir</email>
        <affiliation>Dezfoul University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh sekhavatpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezfoul University of Medical Science, Paramedicine</address>
        <city>Dezfoul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64611-58119</zip>
        <telephone>+98 61 4222 0627</telephone>
        <email>Sekhavat.z@dums.ac.ir</email>
        <affiliation>Dezfoul University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 4 -8 years; Lack of chronic diseases (cancer, liver disease and kidney); Have good speaking and hearing abilities; The presence of a parent or guardian at the time of admission; No surgery and hospitalization in the past; The lack of central nervous system diseases and mental illness; Exclusion criteria: Children and parents not wanting to continue studying; Stopping the surgery under any conditions; lack of cooperation in listening to the story.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.2</hc_code>
      <hc_code>R46.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>specific (isolated) phobias</hc_keyword>
      <hc_keyword>Undue concern and preoccupation with stressful events</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the story book will be read For 30 minutes on the night before surgery. The researcher would fill the anxiety and the behavioral disorders questionnaire before and after surgery and 10 days after through a phone call with the child's mother. This story will be designed in four parts. Part I: Presentation of information. In this section, two types of information would be given to children. Information regarding procedures includes basic information about the surgery and everything from the entry to exit from the hospital and sensory information includes feelings such as pain, itching, burning, pain in the region of the cut, and nausea and numbness that can be experienced during the treatment would be told to the child. Part II: Behavioral guidelines. In this section, effective behaviors such as breathing before the start of anesthesia would be told to the child and they would be playing the roles. And the child would be asked to repeat them. Part III: Cognitive interventions. In this part of the story book, the researcher would show images of the operating room along with all the equipment used in operating rooms to the child and this will change the child's recognition of the fact that these instruments will be painful. After telling the story for the child, he will be asked to do the works and tell his parents about them in order to review them in his mind. Part IV: Emotional interventions. In the entire process in this story book, the child would be asked to express his feelings and emotions such as anxiety or fear clearly. The child may tell us which part or parts make him frightened more or what he is anxious about.</i_keyword>
      <i_keyword>Control group:  Only routine will be performed. In order to avoid any bias, the anxiety questionnaire would be filled before and after surgery and ten days after intervention of the assessment group including child's clinical psychologist, a nurse and the researcher in this section. Then the researcher would review the child's behavioral disorder through a self-made questionnaire before surgery and ten days after surgery by a phone calling talking to the child's mother</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Manifest and hidden  Anxiety children. Timepoint: Immediately after the intervention and before surgery and after 10 days. Method of measurement: RCMAS scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavioral disturbances. Timepoint: Before and 10 days after operation. Method of measurement: Created researcher questionnaire.</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, Dezfoul University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-29</approval_date>
        <contact_name>Ethic committee of Dezfoul University of Medical Science</contact_name>
        <contact_address>Azadegan Blvd dezful  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
