Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial (Anx'Appli)

May 30, 2022 updated by: University Hospital, Rouen
The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child between 4 years old (inclusive) and 10 years old (inclusive);
  • Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
  • Benefiting from a social security scheme;
  • Whose parental authority has consented to participation in the research;
  • Not having expressed their refusal to participate in the research;
  • Understanding French;
  • Ability to access the application being researched.

Exclusion Criteria:

  • Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
  • Poor understanding of oral French by the child;
  • Poor understanding of the oral and/or written French language by the parent/legal representative;
  • Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
  • Patient with severe psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
patient benefiting from a traditional anesthesia consultation as performed daily in the department (control group). The information will be delivered according to local customs and the MAR: oral, which can be supplemented by the delivery of the SPARADRAP booklet and the written documents usually delivered
Experimental: experimental group
patient benefiting, in addition to this traditional anesthesia consultation, from additional information via the computerized tool. The operation of this tool will be explained by paramedical staff and its access will be free as soon as you leave the consultation.
Other: additional information via the computerized tool
additional information delivered via the computerized tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of anxiety on entering the operating room
Time Frame: 15 days
YALE score (also called m-YPAS SF) : 22.9 to 100
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety of parents
Time Frame: 15 days
EVA (Analogic Visual Scale) score : 0 to 10
15 days
Need of an analgesic supplement in SSPI (post-interventional monitoring room)
Time Frame: 15 days
15 days
Duration of stay in SSPI
Time Frame: 15 days
Stay in SSPI in minutes
15 days
Parents' satisfaction with the quality of the information provided
Time Frame: 15 days
numerical scale : 0 to 10
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Vincent Compere, Rouen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2022

Primary Completion (Anticipated)

February 15, 2024

Study Completion (Anticipated)

February 15, 2024

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/087/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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