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

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
Pediatric Surgery

Intervention / Treatment
-----------------
* Other: additional information via the computerized tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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<br>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<br>* additional information delivered via the computerized tool<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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