Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction
Condition: Children; Ambulatory Surgery; General Anesthesia
Study type: Interventional

Summary: 
      This study focuses on preoperative anxiety in children and non-drug methods to reduce
      anxiety.

      During surgery under general anesthesia, children may be anxious because of separation from
      their parents, fear of anesthesia, or loss of control.

      In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic
      medicine. This premedication can reduce the anxiety of children. However, side effects are
      often observed as rebound anxiety after the operation or a delay to discharge from hospital.

      In recent years, alternative methods to premedication have been studied to reduce the anxiety
      of children. For example, video games and cartoons are distraction methods. Studies have
      shown that using a video game or cartoon during the waiting phases (in the room, when
      traveling, in the permutation room) reduces the anxiety of children and with the same
      efficiency as anxiolytic.

      In this study, the investigators will evaluate the effectiveness of a tablet game and a
      cartoon to reduce the anxiety of children.
    

Detailed description: 
      This study takes an interest on the problem of the well-being of children during an
      outpatient surgery.

      Children are often anxious before a surgery under general anesthetic because of unfamiliar
      environments, separation from parents, loss of control or uncertainty about anesthesia. 50%
      to 70% of children develop anxiety after surgery. Anxiety before surgery are associated with
      behavioral changes in postoperative like increase in anxiety, sleep or eating disturbances
      and with postoperative pain.

      To reduce this preoperative anxiety, the use of anxiolytics (hypnovel, hydroxizyne) is the
      most commonly used method. But this premedication remains controversial (paradoxical effects
      with rebound of anxiety, loss of explicit memorization).

      The aim of this study is to examine two non-pharmacological and non-invasive methods
      (technological distraction through video games and animated cartoons) that seem to be
      effective in reducing preoperative anxiety and its postoperative repercussions. Much studies
      show the benefits of preoperative distraction method to reduce children's anxiety, such as
      cartoons, video games, puzzles.

      It is now necessary to understand the processes underlying the relationship between the
      preoperative anxiety and distraction method.

      Video games and cartoons are supposed to foster a high level of cognitive engagement in
      children, which would allow them to focus less on the anxiogenic elements of the operating
      context and thus reduce their preoperative anxiety. This state of cognitive engagement is
      called flow. Flow is defined as a state in which person is so involved in an activity that
      nothing else matters.

      Within the paediatric anaesthesia department of the University Hospital Rennes Sud, the
      playful video game "Le Héros C'est Toi" is systematically offered to children aged 3 to 10
      years to accompany them throughout the course of care during outpatient surgery. This has
      been a standard practice since 2014.

      In this project, the aim is to examine the links between the state of flow, generated by a
      playful application on tablet or animated cartoon, and the preoperative anxiety of children.

      Protocol :

      The day of the intervention surgery, the study is proposed to the parents and the children on
      their arrival. If the participants are in favor, the consent documents are given to them.
      Patient inclusion is ongoing, after verification of inclusion criteria, parental consent and
      signed consent. The attribution to the game-video or cartoon group is carried out according
      to a randomization by block " week ".

      At their arrival in ambulatory care service, when child is in the room a first video
      recording is made in order to examine the anxiety of the child. Then tablet with the video
      game or animated cartoon is made available to the child. The tablet is available to the child
      until anesthetic induction.

      Four others video recording are made :

        -  before the child leaves for the waiting room to examine the flow state of the child
           until the separation with the parents to examine the anxiety of the child,

        -  when the child is in the waiting room to examine the flow state of the child

        -  and during the anesthetic induction to examine the anxiety of the child.

      While the children are in the operating room, parents must complete questionnaires to
      evaluate anxiety-trait of the children and anxiety-state of the parent.

      The pain's score and the emergence delirium of the child on waking are recorded.

      The day after the intervention, a call is made to parents to examine the postoperative
      behavioral changes of the children. Two other calls are made a week after and a month after.

      Materials:

      To examine the anxiety-state of the child on video recording the investigators use an
      observational grid, the mYPAS To examine the anxiety-trait of the child the investigators use
      the questionnaire PAS-R To examine the anxiety-state of the parents the investigators use the
      questionnaire STAI-S To examine the pain of the child on waking the investigatorsuse an
      observational grid FLACC To examine the emergence delirium of the child on waking the
      investigators use an observational grid, the EPAD To examine the flow state on video
      recording of the child, the investigatorsuse an observational grid. This tool is currently
      psychometrically tested.

      To examine the postoperative behavioral change, the investigators use the questionnaire PHBQ
    

Intervention name(s): Video game; Animated cartoon
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask.
The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children.; Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask.
The cartoon used is "L'âge de glace", an animated cartoon geared to children.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
Masking: None (Open Label)
Primary purpose: Other
Keywords: Preoperative anxiety; Distractions; Flow; Child