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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02490995

Enrollment

Registered

2015-07-07

Start date

2014-11-30

Completion date

2016-02-29

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Linked to the Surgery and / or Anesthesia

Keywords

children

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.

Interventions

OTHERMovie

Besides the anesthesist explanations the children will have a movie explanation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026