Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.

Not Applicable

Completed

• Conditions: Anxiety Linked to the Surgery and / or Anesthesia

• Registration Number: NCT02490995
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Yale Preoperative Anxiety Scale (m-YPAS)	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 Outcome Measures

Name	Time	Method
The agitation in recovery room	First 15 minutes of the arrival in recovery room	The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment)
psychometric validation of the SAS (self anxiety scale)	up to postoperative day 30	validation of the self report anxiety scale
Induction Compliance Checklist (ICC)	intraoperative	Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)

Trial Locations

Locations (1)

Montpellier university hospital; 🇫🇷 Montpellier, France