Montpellier university hospital
Montpellier, 34295, France
Completed
NCT Number: NCT02490995
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.
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.
Completed
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Notify MeKey information
Age range
Up to 12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Movie
OtherBesides the anesthesist explanations the children will have a movie explanation.
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)
Time frame: intraoperative
Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)
-
The agitation in recovery room
Time frame: 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)
Time frame: up to postoperative day 30
validation of the self report anxiety scale
Sponsors and collaborators
Lead sponsor
University Hospital, Montpellier
Other
Registry information
Official study title
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.
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 7, 2015
- Registry last updated
- Nov 21, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.