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

Primary Purpose

Anxiety Linked to the Surgery and / or Anesthesia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Movie

About this trial

This is an interventional supportive care trial for Anxiety Linked to the Surgery and / or Anesthesia focused on measuring children

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

Montpellier university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A

Group B

Arm Description

Information given by the anaesthetist during the consultation

Movie + Information given by the anaesthetist during the consultation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Induction Compliance Checklist (ICC)

Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)

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)

psychometric validation of the SAS (self anxiety scale)

validation of the self report anxiety scale

Full Information

NCT ID

NCT02490995

First Posted

July 2, 2015

Last Updated

November 19, 2019

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02490995

Brief Title

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

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

November 2014 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Linked to the Surgery and / or Anesthesia

Keywords

children

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

No Intervention

Arm Description

Information given by the anaesthetist during the consultation

Arm Title

Group B

Arm Type

Experimental

Arm Description

Movie + Information given by the anaesthetist during the consultation

Intervention Type

Other

Intervention Name(s)

Movie

Intervention Description

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

Primary Outcome Measure Information:

Title

The Yale Preoperative Anxiety Scale (m-YPAS)

Description

Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)

Time Frame

the 1 surgery day at the time of the separation parents-children

Secondary Outcome Measure Information:

Title

Induction Compliance Checklist (ICC)

Description

Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)

Time Frame

intraoperative

Title

The agitation in recovery room

Description

The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment)

Time Frame

First 15 minutes of the arrival in recovery room

Title

psychometric validation of the SAS (self anxiety scale)

Description

validation of the self report anxiety scale

Time Frame

up to postoperative day 30

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie SB Bringuier, PhD

Organizational Affiliation

Montpellier University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montpellier university hospital

City

Montpellier

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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