Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children
Condition: Anxiety State; Parent-Child Relations
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): info; smartphone
Intervention type(s): Behavioral; Behavioral
Intervention description(s): the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.; the child received smartphone application immediately before entering the operating room
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Anxiety; Anesthesia; Evaluation; Preoperative care; Child