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Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery (PTIBOLID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03961581
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.

Condition or disease Intervention/treatment Phase
Children Undergoing Surgery Under General Anesthesia Behavioral: Using electric car Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery: a Randomised Controlled Study
Estimated Study Start Date : June 27, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: car
Children who will use cars to go from the double-door entrance of the block to the operative room.
Behavioral: Using electric car
Child will use little electric cars to go to the reception of operating theatre to operating room.

No Intervention: bed
Children who will use bed to go from the double-door entrance of the block to the operative room.

Primary Outcome Measures :
  1. Peri operative anxiety [ Time Frame: 30 minutes ]
    Perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS )questionnaire.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children operated in ENT and ophtalmology
  • Max 35 kg (advice from little electric car manufacturer)
  • 2 years old minimum (psychomotor coordination)
  • 10 years old maximum
  • Ambulatory unit

Exclusion Criteria:

  • < 2 years old
  • Cognitive and physical impairment that forbids the use of cars
  • Refusal of cooperation of the child
  • Emergency surgery
  • Consent of one of the parents for the study
  • Refusal of cooperation of the parents
  • Lack of understanding of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03961581

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Contact: Claire SCHMIDT, IADE 04 91 96 42 71

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Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: SCHMIDT Claire         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: Jean Olivier ARNAUD Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT03961581     History of Changes
Other Study ID Numbers: 2019-02
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No