Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.

University Hospital, Montpellier1 site in 1 country80 target enrollmentNovember 2014

ConditionsAnxiety Linked to the Surgery and / or Anesthesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Linked to the Surgery and / or Anesthesia
Sponsor: University Hospital, Montpellier
Enrollment: 80
Locations: 1
Primary Endpoint: The Yale Preoperative Anxiety Scale (m-YPAS)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

February 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient who need a surgery
•Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
•Old patient under age 12
•Patient whose parents agreed to participate

Exclusion Criteria

•Patient with psychomotor limitations
•Patient that had already been hospitalised for a surgery

Outcomes

Primary Outcomes

The Yale Preoperative Anxiety Scale (m-YPAS)

Time Frame: the 1 surgery day at the time of the separation parents-children

Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)

Secondary Outcomes

Induction Compliance Checklist (ICC)(intraoperative)
The agitation in recovery room(First 15 minutes of the arrival in recovery room)
psychometric validation of the SAS (self anxiety scale)(up to postoperative day 30)