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
• Interventions: Other: Movie

• 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

Arm && Interventions

Group	Intervention	Description
Group B	Movie	Movie + Information given by the anaesthetist during the consultation

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
Induction Compliance Checklist (ICC)	intraoperative	Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)
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

Trial Locations

Locations (1)

Montpellier university hospital; 🇫🇷 Montpellier, France