Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery (PTIBOLID)
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|ClinicalTrials.gov Identifier: NCT03961581|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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|
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.
- Peri operative anxiety [ Time Frame: 30 minutes ]Perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS )questionnaire.
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 ClinicalTrials.gov identifier (NCT number): NCT03961581
|Contact: Claire SCHMIDT, IADE||04 91 96 42 71||Claire.SCHMIDT@ap-hm.fr|
|Assistance Publique Hôpitaux de Marseille||Not yet recruiting|
|Marseille, France, 13354|
|Contact: SCHMIDT Claire|
|Study Director:||Jean Olivier ARNAUD||Assistance Publique Hôpitaux de Marseille|