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.

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 Overview

• Status: Completed
• Conditions: Anxiety Linked to the Surgery and / or Anesthesia
• Intervention / Treatment: Other: Movie

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; Information given by the anaesthetist during the consultation
Experimental: Group B; Movie + Information given by the anaesthetist during the consultation	Other: Movie; Besides the anesthesist explanations the children will have a movie explanation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Yale Preoperative Anxiety Scale (m-YPAS)	Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)	the 1 surgery day at the time of the separation parents-children

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sophie SB Bringuier, PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: children
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 9392; 2014-A00416-41 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:

Time Frame:

12 months after the main publication

Access Criteria:

Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:

• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: CSR