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

NCT03961581 | Completed

• 1 other identifier: 2019-02
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Peri operative anxiety

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

  30 minutes

Study Arms (2)

car

EXPERIMENTAL

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

Behavioral: Using electric car

bed

NO INTERVENTION

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

Interventions

Using electric car BEHAVIORAL

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

car

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.

  PMID: 36204923 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean Olivier ARNAUD

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 23, 2019
• Study Start: August 30, 2019
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

FR (1)