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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-30

Study Completion Date

2021-04-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery

NCT03763292

Anxiety Consumer Satisfaction

COMPLETED NA

Preparing Children for Anesthesia With an Educational Pop-Up Book

NCT04796077

Pediatric Preoperative Anxiety, Pediatric Coping

COMPLETED NA

Effect of Educational Intervention on Children's Anxiety

NCT06600113

Health Literacy Anesthesia Anxiety +4 more

RECRUITING NA

Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)

NCT00337870

Anxiety Pain

COMPLETED PHASE2

Evaluation of Post-PACU Pain Management in Pediatric Surgery

NCT02352116

Pain

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

car

Children who will use cars to go from the double-door entrance of the block to the operative room.

Group Type EXPERIMENTAL

Using electric car

Intervention Type BEHAVIORAL

Child will use little electric cars to go to the reception of operating theatre to operating room.

bed

Children who will use bed to go from the double-door entrance of the block to the operative room.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Using electric car

Child will use little electric cars to go to the reception of operating theatre to operating room.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No