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

NCT ID: NCT05401617

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-10-24

Brief Summary

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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

Detailed Description

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Conditions

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Pediatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

additional information via the computerized tool

Intervention Type OTHER

additional information delivered via the computerized tool

Interventions

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additional information via the computerized tool

additional information delivered via the computerized tool

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Compere

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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UHRouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2019/0087/HP

Identifier Type: -

Identifier Source: org_study_id

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