<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246062</url>
  </required_header>
  <id_info>
    <org_study_id>288.712</org_study_id>
    <nct_id>NCT02246062</nct_id>
  </id_info>
  <brief_title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children</brief_title>
  <official_title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Ciências Médicas da Santa Casa de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Ciências Médicas da Santa Casa de São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience.&#xD;
      Among the strategies for reducing children's anxiety, non-pharmacological strategies are as&#xD;
      important as the pharmacological ones, but their its validity is still controversial.&#xD;
&#xD;
      Objectives: The aim of this study is to verify if the information provided to relatives as&#xD;
      well as and smartphone application provided to children interferes in prevalence and level of&#xD;
      child preoperative anxiety.&#xD;
&#xD;
      Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical&#xD;
      procedures and their relatives are randomly allocated into four groups: control group (CG)&#xD;
      where the relative received conventional information about anesthesia; info group (IG),&#xD;
      relative received an information leaflet about anesthesia; device group (DG), relative&#xD;
      received only conventional verbal information and the child received smartphone application&#xD;
      immediately before entering the operating room; device and info group (DIG) relative received&#xD;
      a leaflet containing information and the child received smartphone application. Children's&#xD;
      anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three&#xD;
      occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating&#xD;
      room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for&#xD;
      prevalence and level of anxiety in the groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction&#xD;
&#xD;
      Intense preoperative anxiety in children has been associated with difficulty in anesthetic&#xD;
      induction. In addition, anxiety of relatives is a factor of great importance and influence on&#xD;
      the preoperative anxiety levels of children and effectively contributes to the development of&#xD;
      behavioral changes in postoperative period.&#xD;
&#xD;
      Distress before surgery has been associated with short- and long-term consequences, including&#xD;
      risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease&#xD;
      children's anxiety can provide suitable induction and minimizes these risks.&#xD;
&#xD;
      It is estimated that 40% to 75% of children undergoing surgery experience significant fear&#xD;
      and anxiety during the preoperative period3-5 Several authors suggest that children under 4&#xD;
      years of age are at greater risk for developing anxiety preoperatively.&#xD;
&#xD;
      Among the strategies for reducing the pediatric population anxiety, the non-pharmacological&#xD;
      approaches through alternative therapies that act on the psychological aspects are as&#xD;
      important as the pharmacological ones 9.&#xD;
&#xD;
      Currently, there is great motivation towards non-pharmacological interventions aimed at&#xD;
      anxiety relief for children and their families, such as parental presence during induction of&#xD;
      anesthesia (PPIA), educational programs to prepare the family, and written information on&#xD;
      anesthetic procedure provided to relatives and/or children. This is due in part to the large&#xD;
      growth in outpatient practice and increased participation and presence of parents during&#xD;
      children's hospitalization, but also to the new institutional strategies that motivate a more&#xD;
      humane medical practice. Furthermore, there have emerged efficient behavioral intervention&#xD;
      programs that use toys, cartoons, video games and smartphones.&#xD;
&#xD;
      It has been suggested the intuitive and easeness of use, and popularity, of smartphones as a&#xD;
      way to make children become absorbed by scrolling through its menus, playing and&#xD;
      investigating its other functions, hence making the anesthesiologists' approach trouble-free.&#xD;
&#xD;
      Some authors showed that using smartphone application and other electronic devices as part of&#xD;
      a behavioral intervention program for children, while taking into account individual&#xD;
      characteristics, may be a simple and effective way to reduce preoperative anxiety.&#xD;
&#xD;
      Objectives The aim of this study is to determine whether the quality of information provided&#xD;
      to relatives at the ward and playing with age appropriate smartphone application may have an&#xD;
      impact on prevalence and level of child's anxiety in the operating room (OR) at the induction&#xD;
      of anesthesia.&#xD;
&#xD;
      Method&#xD;
&#xD;
      After approval by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo, an&#xD;
      open randomized clinical trial should be conducted to compare the level of anxiety of&#xD;
      children and their relatives, according to the quality of information and use or not of&#xD;
      smartphone application received in the preanesthetic period.&#xD;
&#xD;
      Eighty-four children undergoing elective surgical procedures and their relatives will be&#xD;
      randomly selected through the List Randomizer program (www.random.org) and allocated into&#xD;
      four groups: control group (CG), in which the relative receive only conventional verbal&#xD;
      information one day before the procedure at ward; informative group (IG), in which the&#xD;
      relative, in addition to conventional verbal information, received a leaflet containing&#xD;
      information about the anesthetic procedure one day before the surgery at ward; smartphone&#xD;
      group (SG), in which the relative received only conventional verbal information one day&#xD;
      before the procedure and the child received smartphone application immediately before&#xD;
      entering the operating room; smartphone and informative group (SIG) in which the relative, in&#xD;
      addition to conventional verbal information, received a leaflet containing information about&#xD;
      the anesthetic procedure one day before the surgery and the child received smartphone&#xD;
      application immediately before entering the operating room.&#xD;
&#xD;
      Developed by the author, the leaflet consists of 17 brief items, such as questions and&#xD;
      answers, and provides information regarding the most frequently asked questions by the&#xD;
      relatives, as observed in our clinical practice. The contents of this informative leaflet&#xD;
      cover aspects of the specialty and practice of anesthesiology, such as suspension and use of&#xD;
      medications, fasting, full stomach and refeeding after anesthesia, laboratory tests,&#xD;
      anesthesia in children, types of anesthesia, risks, induction and recovery room, presence of&#xD;
      parents, and how to contribute to a peaceful anesthesia in children.&#xD;
&#xD;
      Inclusion criteria are ASA physical status I, II and III, according to the classification of&#xD;
      the American Society of Anesthesiologists (ASA), age between 4 and 8 years, undergoing&#xD;
      minor-medium elective surgical procedures with an indication of general anesthesia, who shall&#xD;
      not receive premedication and whose parents are not illiterate.&#xD;
&#xD;
      The exclusion criteria for children are psychomotor deficits, use of psychoactive drugs,&#xD;
      hearing and visual impairment, previous surgery; and for relatives, the exclusion criteria&#xD;
      are illness or mental disorder clinically recognized and decline to participate.&#xD;
&#xD;
      The study begins always in the ward (W), one day before the procedure, during preanesthesia&#xD;
      evaluation and on the conventional provision of information about anesthesia. One of the&#xD;
      researchers applies the observational m-YPAS scale for child and then the relatives are fully&#xD;
      informed about the characteristic of the study and will be asked to sign the consent form. At&#xD;
      the end of the preanesthetic evaluation (APA) the relatives of the IG and SIG groups receive&#xD;
      an information leaflet.&#xD;
&#xD;
      At the day of the procedure, in the waiting room (WR) of surgical centers, before the child&#xD;
      is taken to the operating room (OR), the child anxiety is assessed by m-YPAS scale. All&#xD;
      groups will also answer a sociodemographic questionnaire and open statement for satisfaction&#xD;
      about the information received. The children of the groups SG and SIG, before taken to the OR&#xD;
      receive smartphones for playing, remaining always accompanied by the relatives until the end&#xD;
      of induction. In the OR, all children undergo standard monitoring and, immediately before&#xD;
      induction of anesthesia through conventional technique (either intravenous or inhalational),&#xD;
      are re-evaluated using m-YPAS (OR time).&#xD;
&#xD;
      Level and prevalence of children's anxiety (m-YPAS), will be measured at three times: ward&#xD;
      (W), waiting room (WR) and operating room (OR) immediately before induction. The&#xD;
      observational m-YPAS was used as originally proposed by Kain et al. A partial score was given&#xD;
      for each domain, based on the score observed by the researcher, divided by the number of&#xD;
      categories in that domain. The score for each domain is added to the others and then&#xD;
      multiplied by 20. Cut-off scores to classify patients are: without anxiety (23.4-30), with&#xD;
      anxiety (&lt; 30).&#xD;
&#xD;
      For sample size calculation, it was considered that the prevalence of children's anxiety in&#xD;
      the operating room is 75% 23 and that the proposed intervention is able to reduce it by 35%&#xD;
      15. Thus, the investigators propose to use α-error of 5%, β-error of 20%, and confidence&#xD;
      interval of 95%, totaling 84 patients, 21 in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</measure>
    <time_frame>24 hours before surgery</time_frame>
    <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&lt; 30).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.</measure>
    <time_frame>Immediately before entering operation room</time_frame>
    <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</measure>
    <time_frame>Immediately before induction of anesthesia</time_frame>
    <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Anxiety State</condition>
  <condition>Parent-Child Relations</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>info group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>smartphone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room</description>
  </arm_group>
  <arm_group>
    <arm_group_label>smartphone and info group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>info</intervention_name>
    <description>the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
    <arm_group_label>info group</arm_group_label>
    <arm_group_label>smartphone and info group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>smartphone</intervention_name>
    <description>the child received smartphone application immediately before entering the operating room</description>
    <arm_group_label>smartphone and info group</arm_group_label>
    <arm_group_label>smartphone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I, II and III a&#xD;
&#xD;
          -  age between 4 and 8 years&#xD;
&#xD;
          -  undergoing minor-medium elective surgical procedures&#xD;
&#xD;
          -  indication of general anesthesia&#xD;
&#xD;
          -  not receive premedication&#xD;
&#xD;
          -  parents are not illiterate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychomotor deficits&#xD;
&#xD;
          -  use of psychoactive drugs&#xD;
&#xD;
          -  hearing and visual impairment&#xD;
&#xD;
          -  previous surgery&#xD;
&#xD;
          -  for relatives, illness or mental disorder clinically recognized and decline to&#xD;
             participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ligia AS Mathias, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Irmandade Santa Casa de Misericórdia de São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Irmandade Santa Casa de Misericórdia de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01221010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Melamed BG, Siegel LJ. Reduction of anxiety in children facing hospitalization and surgery by use of filmed modeling. J Consult Clin Psychol. 1975 Aug;43(4):511-21. doi: 10.1037/h0076896. No abstract available.</citation>
    <PMID>1159149</PMID>
  </reference>
  <reference>
    <citation>Lumley MA, Melamed BG, Abeles LA. Predicting children's presurgical anxiety and subsequent behavior changes. J Pediatr Psychol. 1993 Aug;18(4):481-97. doi: 10.1093/jpepsy/18.4.481.</citation>
    <PMID>8410571</PMID>
  </reference>
  <reference>
    <citation>Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.</citation>
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  <reference>
    <citation>Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.</citation>
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  <reference>
    <citation>Bevan JC, Johnston C, Haig MJ, Tousignant G, Lucy S, Kirnon V, Assimes IK, Carranza R. Preoperative parental anxiety predicts behavioural and emotional responses to induction of anaesthesia in children. Can J Anaesth. 1990 Mar;37(2):177-82. doi: 10.1007/BF03005466.</citation>
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  </reference>
  <reference>
    <citation>Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.</citation>
    <PMID>10320165</PMID>
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    <citation>Kain ZN, Mayes LC, Weisman SJ, Hofstadter MB. Social adaptability, cognitive abilities, and other predictors for children's reactions to surgery. J Clin Anesth. 2000 Nov;12(7):549-54. doi: 10.1016/s0952-8180(00)00214-2.</citation>
    <PMID>11137417</PMID>
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    <citation>Kain ZN, Mayes LC, Caldwell-Andrews AA, Saadat H, McClain B, Wang SM. Predicting which children benefit most from parental presence during induction of anesthesia. Paediatr Anaesth. 2006 Jun;16(6):627-34. doi: 10.1111/j.1460-9592.2006.01843.x.</citation>
    <PMID>16719878</PMID>
  </reference>
  <reference>
    <citation>Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.</citation>
    <PMID>17197846</PMID>
  </reference>
  <reference>
    <citation>Astuto M, Rosano G, Rizzo G, Disma N, Raciti L, Sciuto O. Preoperative parental information and parents' presence at induction of anaesthesia. Minerva Anestesiol. 2006 Jun;72(6):461-5.</citation>
    <PMID>16682916</PMID>
  </reference>
  <reference>
    <citation>Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.</citation>
    <PMID>17179531</PMID>
  </reference>
  <reference>
    <citation>Chundamala J, Wright JG, Kemp SM. An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. Can J Anaesth. 2009 Jan;56(1):57-70. doi: 10.1007/s12630-008-9008-3. Epub 2008 Dec 20.</citation>
    <PMID>19247779</PMID>
  </reference>
  <reference>
    <citation>Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.</citation>
    <PMID>23011563</PMID>
  </reference>
  <reference>
    <citation>Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.</citation>
    <PMID>23051880</PMID>
  </reference>
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    <citation>Lee JH, Jung HK, Lee GG, Kim HY, Park SG, Woo SC. Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients. Korean J Anesthesiol. 2013 Dec;65(6):508-18. doi: 10.4097/kjae.2013.65.6.508. Epub 2013 Dec 26.</citation>
    <PMID>24427456</PMID>
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  <reference>
    <citation>Low DK, Pittaway AP. The 'iPhone' induction - a novel use for the Apple iPhone. Paediatr Anaesth. 2008 Jun;18(6):573-4. doi: 10.1111/j.1460-9592.2008.02498.x. Epub 2008 Feb 28. No abstract available.</citation>
    <PMID>18312515</PMID>
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    <citation>Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.</citation>
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  <reference>
    <citation>Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a &quot;gold standard&quot;? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.</citation>
    <PMID>9322455</PMID>
  </reference>
  <reference>
    <citation>Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. doi: 10.1590/s0034-70942007000100006. English, Portuguese.</citation>
    <PMID>19468618</PMID>
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  <reference>
    <citation>Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.</citation>
    <PMID>6880820</PMID>
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  </reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>March 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>June 11, 2015</results_first_submitted>
  <results_first_submitted_qc>December 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 7, 2016</results_first_posted>
  <last_update_submitted>December 4, 2015</last_update_submitted>
  <last_update_submitted_qc>December 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Ciências Médicas da Santa Casa de São Paulo</investigator_affiliation>
    <investigator_full_name>Débora de Oliveira Cumino</investigator_full_name>
    <investigator_title>MSC</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Evaluation</keyword>
  <keyword>Preoperative care</keyword>
  <keyword>Child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
        </group>
        <group group_id="P2">
          <title>Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
        </group>
        <group group_id="P3">
          <title>Smartphone Group</title>
          <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
        <group group_id="P4">
          <title>Smartphone and Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
        </group>
        <group group_id="B2">
          <title>Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
        </group>
        <group group_id="B3">
          <title>Smartphone Group</title>
          <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
        <group group_id="B4">
          <title>Smartphone and Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="21"/>
            <count group_id="B5" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.29" spread="1.15"/>
                    <measurement group_id="B2" value="5.45" spread="1.0"/>
                    <measurement group_id="B3" value="5.29" spread="0.96"/>
                    <measurement group_id="B4" value="5.65" spread="1.04"/>
                    <measurement group_id="B5" value="5.41" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</title>
        <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&lt; 30).</description>
        <time_frame>24 hours before surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
          </group>
          <group group_id="O2">
            <title>Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
          </group>
          <group group_id="O3">
            <title>Smartphone Group</title>
            <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
          <group group_id="O4">
            <title>Smartphone and Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</title>
          <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&lt; 30).</description>
          <units>units on a scale m-YPAS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" spread="10.26"/>
                    <measurement group_id="O2" value="24.18" spread="2.12"/>
                    <measurement group_id="O3" value="23.79" spread="1.27"/>
                    <measurement group_id="O4" value="24.98" spread="6.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.</title>
        <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
        <time_frame>Immediately before entering operation room</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
          </group>
          <group group_id="O2">
            <title>Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
          </group>
          <group group_id="O3">
            <title>Smartphone Group</title>
            <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
          <group group_id="O4">
            <title>Smartphone and Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.</title>
          <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
          <units>units on a scale m-YPAS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.88" spread="13.94"/>
                    <measurement group_id="O2" value="23.88" spread="2.18"/>
                    <measurement group_id="O3" value="25.85" spread="6.44"/>
                    <measurement group_id="O4" value="25.93" spread="9.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</title>
        <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
        <time_frame>Immediately before induction of anesthesia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
          </group>
          <group group_id="O2">
            <title>Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
          </group>
          <group group_id="O3">
            <title>Smartphone Group</title>
            <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
          <group group_id="O4">
            <title>Smartphone and Info Group</title>
            <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.</title>
          <description>The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (&gt; 30).</description>
          <units>units on a scale m-YPAS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.13" spread="23.65"/>
                    <measurement group_id="O2" value="30.29" spread="14.40"/>
                    <measurement group_id="O3" value="36.55" spread="19.08"/>
                    <measurement group_id="O4" value="28.23" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <desc>adverse event assessment was based on drop out rate</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>in which the relative receive only conventional verbal information one day before the procedure at ward.</description>
        </group>
        <group group_id="E2">
          <title>Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.</description>
        </group>
        <group group_id="E3">
          <title>Smartphone Group</title>
          <description>in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
        <group group_id="E4">
          <title>Smartphone and Info Group</title>
          <description>in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.&#xD;
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.&#xD;
smartphone: the child received smartphone application immediately before entering the operating room</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Débora de Oliveira Cumino</name_or_title>
      <organization>Faculdade de ciências médicas da Santa Casa de São Paulo</organization>
      <phone>+55 11 33617333</phone>
      <email>comissaocientifica@fcmsantacasasp.edu.br</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246062
org study id: 288.712
nct id: NCT02246062
lead sponsor: 
has dmc: Yes
Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience.
      Among the strategies for reducing children's anxiety, non-pharmacological strategies are as
      important as the pharmacological ones, but their its validity is still controversial.

      Objectives: The aim of this study is to verify if the information provided to relatives as
      well as and smartphone application provided to children interferes in prevalence and level of
      child preoperative anxiety.

      Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical
      procedures and their relatives are randomly allocated into four groups: control group (CG)
      where the relative received conventional information about anesthesia; info group (IG),
      relative received an information leaflet about anesthesia; device group (DG), relative
      received only conventional verbal information and the child received smartphone application
      immediately before entering the operating room; device and info group (DIG) relative received
      a leaflet containing information and the child received smartphone application. Children's
      anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three
      occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating
      room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for
      prevalence and level of anxiety in the groups.
Introduction

      Intense preoperative anxiety in children has been associated with difficulty in anesthetic
      induction. In addition, anxiety of relatives is a factor of great importance and influence on
      the preoperative anxiety levels of children and effectively contributes to the development of
      behavioral changes in postoperative period.

      Distress before surgery has been associated with short- and long-term consequences, including
      risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease
      children's anxiety can provide suitable induction and minimizes these risks.

      It is estimated that 40% to 75% of children undergoing surgery experience significant fear
      and anxiety during the preoperative period3-5 Several authors suggest that children under 4
      years of age are at greater risk for developing anxiety preoperatively.

      Among the strategies for reducing the pediatric population anxiety, the non-pharmacological
      approaches through alternative therapies that act on the psychological aspects are as
      important as the pharmacological ones 9.

      Currently, there is great motivation towards non-pharmacological interventions aimed at
      anxiety relief for children and their families, such as parental presence during induction of
      anesthesia (PPIA), educational programs to prepare the family, and written information on
      anesthetic procedure provided to relatives and/or children. This is due in part to the large
      growth in outpatient practice and increased participation and presence of parents during
      children's hospitalization, but also to the new institutional strategies that motivate a more
      humane medical practice. Furthermore, there have emerged efficient behavioral intervention
      programs that use toys, cartoons, video games and smartphones.

      It has been suggested the intuitive and easeness of use, and popularity, of smartphones as a
      way to make children become absorbed by scrolling through its menus, playing and
      investigating its other functions, hence making the anesthesiologists' approach trouble-free.

      Some authors showed that using smartphone application and other electronic devices as part of
      a behavioral intervention program for children, while taking into account individual
      characteristics, may be a simple and effective way to reduce preoperative anxiety.

      Objectives The aim of this study is to determine whether the quality of information provided
      to relatives at the ward and playing with age appropriate smartphone application may have an
      impact on prevalence and level of child's anxiety in the operating room (OR) at the induction
      of anesthesia.

      Method

      After approval by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo, an
      open randomized clinical trial should be conducted to compare the level of anxiety of
      children and their relatives, according to the quality of information and use or not of
      smartphone application received in the preanesthetic period.

      Eighty-four children undergoing elective surgical procedures and their relatives will be
      randomly selected through the List Randomizer program (www.random.org) and allocated into
      four groups: control group (CG), in which the relative receive only conventional verbal
      information one day before the procedure at ward; informative group (IG), in which the
      relative, in addition to conventional verbal information, received a leaflet containing
      information about the anesthetic procedure one day before the surgery at ward; smartphone
      group (SG), in which the relative received only conventional verbal information one day
      before the procedure and the child received smartphone application immediately before
      entering the operating room; smartphone and informative group (SIG) in which the relative, in
      addition to conventional verbal information, received a leaflet containing information about
      the anesthetic procedure one day before the surgery and the child received smartphone
      application immediately before entering the operating room.

      Developed by the author, the leaflet consists of 17 brief items, such as questions and
      answers, and provides information regarding the most frequently asked questions by the
      relatives, as observed in our clinical practice. The contents of this informative leaflet
      cover aspects of the specialty and practice of anesthesiology, such as suspension and use of
      medications, fasting, full stomach and refeeding after anesthesia, laboratory tests,
      anesthesia in children, types of anesthesia, risks, induction and recovery room, presence of
      parents, and how to contribute to a peaceful anesthesia in children.

      Inclusion criteria are ASA physical status I, II and III, according to the classification of
      the American Society of Anesthesiologists (ASA), age between 4 and 8 years, undergoing
      minor-medium elective surgical procedures with an indication of general anesthesia, who shall
      not receive premedication and whose parents are not illiterate.

      The exclusion criteria for children are psychomotor deficits, use of psychoactive drugs,
      hearing and visual impairment, previous surgery; and for relatives, the exclusion criteria
      are illness or mental disorder clinically recognized and decline to participate.

      The study begins always in the ward (W), one day before the procedure, during preanesthesia
      evaluation and on the conventional provision of information about anesthesia. One of the
      researchers applies the observational m-YPAS scale for child and then the relatives are fully
      informed about the characteristic of the study and will be asked to sign the consent form. At
      the end of the preanesthetic evaluation (APA) the relatives of the IG and SIG groups receive
      an information leaflet.

      At the day of the procedure, in the waiting room (WR) of surgical centers, before the child
      is taken to the operating room (OR), the child anxiety is assessed by m-YPAS scale. All
      groups will also answer a sociodemographic questionnaire and open statement for satisfaction
      about the information received. The children of the groups SG and SIG, before taken to the OR
      receive smartphones for playing, remaining always accompanied by the relatives until the end
      of induction. In the OR, all children undergo standard monitoring and, immediately before
      induction of anesthesia through conventional technique (either intravenous or inhalational),
      are re-evaluated using m-YPAS (OR time).

      Level and prevalence of children's anxiety (m-YPAS), will be measured at three times: ward
      (W), waiting room (WR) and operating room (OR) immediately before induction. The
      observational m-YPAS was used as originally proposed by Kain et al. A partial score was given
      for each domain, based on the score observed by the researcher, divided by the number of
      categories in that domain. The score for each domain is added to the others and then
      multiplied by 20. Cut-off scores to classify patients are: without anxiety (23.4-30), with
      anxiety (< 30).

      For sample size calculation, it was considered that the prevalence of children's anxiety in
      the operating room is 75% 23 and that the proposed intervention is able to reduce it by 35%
      15. Thus, the investigators propose to use α-error of 5%, β-error of 20%, and confidence
      interval of 95%, totaling 84 patients, 21 in each group.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
time frame: 24 hours before surgery
description: The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.
time frame: Immediately before entering operation room
description: The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
time frame: Immediately before induction of anesthesia
description: The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).
arm group label: Control group
arm group type: No Intervention
description: in which the relative receive only conventional verbal information one day before the procedure at ward.
arm group label: info group
arm group type: Active Comparator
description: in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
arm group label: smartphone group
arm group type: Active Comparator
description: in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
arm group label: smartphone and info group
arm group type: Active Comparator
description: in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
intervention type: Behavioral
intervention name: info
description: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
arm group label: info group
arm group label: smartphone and info group
intervention type: Behavioral
intervention name: smartphone
description: the child received smartphone application immediately before entering the operating room
arm group label: smartphone and info group
arm group label: smartphone group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ligia AS Mathias, PhD
role: Study Director
affiliation: Irmandade Santa Casa de Misericórdia de São Paulo
facility: 
country: Brazil
citation: Melamed BG, Siegel LJ. Reduction of anxiety in children facing hospitalization and surgery by use of filmed modeling. J Consult Clin Psychol. 1975 Aug;43(4):511-21. doi: 10.1037/h0076896. No abstract available.
PMID: 1159149
citation: Lumley MA, Melamed BG, Abeles LA. Predicting children's presurgical anxiety and subsequent behavior changes. J Pediatr Psychol. 1993 Aug;18(4):481-97. doi: 10.1093/jpepsy/18.4.481.
PMID: 8410571
citation: Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PMID: 8953995
citation: ECKENHOFF JE. Relationship of anesthesia to postoperative personality changes in children. AMA Am J Dis Child. 1953 Nov;86(5):587-91. doi: 10.1001/archpedi.1953.02050080600004. No abstract available.
PMID: 13103772
citation: Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.
PMID: 12641680
citation: Bevan JC, Johnston C, Haig MJ, Tousignant G, Lucy S, Kirnon V, Assimes IK, Carranza R. Preoperative parental anxiety predicts behavioural and emotional responses to induction of anaesthesia in children. Can J Anaesth. 1990 Mar;37(2):177-82. doi: 10.1007/BF03005466.
PMID: 2311148
citation: Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
PMID: 10320165
citation: Kain ZN, Mayes LC, Weisman SJ, Hofstadter MB. Social adaptability, cognitive abilities, and other predictors for children's reactions to surgery. J Clin Anesth. 2000 Nov;12(7):549-54. doi: 10.1016/s0952-8180(00)00214-2.
PMID: 11137417
citation: Kain ZN, Mayes LC, Caldwell-Andrews AA, Saadat H, McClain B, Wang SM. Predicting which children benefit most from parental presence during induction of anesthesia. Paediatr Anaesth. 2006 Jun;16(6):627-34. doi: 10.1111/j.1460-9592.2006.01843.x.
PMID: 16719878
citation: Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
PMID: 17197846
citation: Astuto M, Rosano G, Rizzo G, Disma N, Raciti L, Sciuto O. Preoperative parental information and parents' presence at induction of anaesthesia. Minerva Anestesiol. 2006 Jun;72(6):461-5.
PMID: 16682916
citation: Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.
PMID: 17179531
citation: Chundamala J, Wright JG, Kemp SM. An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. Can J Anaesth. 2009 Jan;56(1):57-70. doi: 10.1007/s12630-008-9008-3. Epub 2008 Dec 20.
PMID: 19247779
citation: Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.
PMID: 23011563
citation: Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
PMID: 23051880
citation: Lee JH, Jung HK, Lee GG, Kim HY, Park SG, Woo SC. Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients. Korean J Anesthesiol. 2013 Dec;65(6):508-18. doi: 10.4097/kjae.2013.65.6.508. Epub 2013 Dec 26.
PMID: 24427456
citation: Low DK, Pittaway AP. The 'iPhone' induction - a novel use for the Apple iPhone. Paediatr Anaesth. 2008 Jun;18(6):573-4. doi: 10.1111/j.1460-9592.2008.02498.x. Epub 2008 Feb 28. No abstract available.
PMID: 18312515
citation: Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
PMID: 24257388
citation: Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PMID: 9322455
citation: Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. doi: 10.1590/s0034-70942007000100006. English, Portuguese.
PMID: 19468618
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PMID: 6880820
citation: Cumino Dde O, Cagno G, Goncalves VF, Wajman DS, Mathias LA. Impact of preanesthetic information on anxiety of parents and children. Braz J Anesthesiol. 2013 Nov-Dec;63(6):473-82. doi: 10.1016/j.bjane.2013.04.003. Epub 2013 Dec 5.
PMID: 24565345
responsible party type: Principal Investigator
investigator affiliation: Faculdade de Ciências Médicas da Santa Casa de São Paulo
investigator full name: Débora de Oliveira Cumino
investigator title: MSC
mesh term: Anxiety Disorders
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 