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Clinical Trials/NCT02490995
NCT02490995CompletedNot Applicable

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 enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
The Yale Preoperative Anxiety Scale (m-YPAS)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Eligibility Criteria

Ages
— to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A

No Intervention

Information given by the anaesthetist during the consultation

Group B

Experimental

Movie + Information given by the anaesthetist during the consultation

Intervention: Movie (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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