Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The main objective of this study is to measure perioperative anxiety in children from 2 to 10
      years old in two distinct homogeneous groups before and after the ride in electric cars
      versus bed travel in the operating room.

      The secondary objectives will be to measure the anxiety at the induction, the pain and the
      agitation of the children in SSPI as well as the satisfaction and the lived experience of the
      parents during the ambulatory stay of their child in the two groups journey in electric cars
      versus trip in bed.

      It is a prospective, randomized, single-centric observational study (small electric cars
      versus bed-ridden), focusing on children during their stay in the operating theater at the
      CHU Nord of Marseille for ENT and ophthalmic surgery.

      This study on the use of electric cars as a means of locomotion within the block may lead to
      other multicenter studies.
    

Detailed description: 
      Peri operative anxiety is one of major issues of pediatric anesthesia. Our efforts to
      decrease children anxiety improve pain, agitation ans behavioral changes during post
      operative period. Guidelines in pediatric anesthesia are to take into account anxiety in
      order to enhance recovery after anesthesia and to develop ambulatory surgery.

      Pharmacological and non pharmacological tools are used. Midazolam is a benzodiazepin widely
      used but its indesirable effects such as paradoxical reactions, prolonged sedation and
      adverse behavioral changes are a brake to enhance recovery after anesthesia programs. Non
      pharmacological procedures are more promising (parental presence, behavioral preparation
      programs and distraction) but their etablishment is time consuming, requiring teaching
      programs, and changing habits. To our knowledge, distraction with ride-on car has not been
      studied yet.

      Little electric car can carry children aged 2 years and more, it can be driven by children
      under adult distant command. Weight is limited to 35 kg (x pounds). Our hospital has 3
      differents car models which allow children to choose for their prefered one et to become part
      of the adventure. Parental separation could be favored by this device.

      Surgical procedures are ophtalmologic and oto rhino laryngologic, in an ambulatory ward
      receiving children ASA 1 to 3. Anesthesic procedure is the same for every child, inhalatory
      induction with sevoflurane following by perfusion for morphinic administration and oral
      intubation. To note, premedication is avoided and replaced by important information and
      reinsurrance of parents.

      Chlidren will be randomised by block every week to go to operating room using gurney (goup a)
      or ride-on electric car (group b). Primary outcome is peri operative pediatric anxiety
      measured by Yale validated scale (m-YPAS). Other outcomes concern post opérative period
      (anxiety, pain, agitation), parental lived and satisfaction.

      PTIBOLID is a monocentric prospective randomised controlled open study wich will include 110
      patients in hopital Nord, Marseille, AP-HM.
    

Intervention name(s): Using electric car
Intervention type(s): Behavioral
Intervention description(s): Child will use little electric cars to go to the reception of operating theatre to operating room.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care