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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT03961581
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.3
• Patients Per Site Per Month: 6

Study Details

Study Description

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
Anxiety	Behavioral: Using electric car	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 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
• Actual Study Start Date: Aug 30, 2019
• Actual Primary Completion Date: Apr 8, 2021
• Actual Study Completion Date: Apr 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Peri operative anxiety [30 minutes]

   Perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS )questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 10 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: Jean Olivier ARNAUD, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT03961581
• Other Study ID Numbers: 2019-02
• First Posted: May 23, 2019
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jul 28, 2022