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

NCT02490995 | Completed

• 2 other identifiers: 93922014-A00416-41
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Linked to the Surgery and / or Anesthesia

Keywords

children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group A

NO INTERVENTION

Information given by the anaesthetist during the consultation

Group B

EXPERIMENTAL

Movie + Information given by the anaesthetist during the consultation

Other: Movie

Interventions

Movie OTHER

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

Group B

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patient with psychomotor limitations
• Patient that had already been hospitalised for a surgery

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier university hospital

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Motion Pictures

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Sophie SB Bringuier, PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.

Locations

FR (1)