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

Not Applicable

• Conditions: Pediatric Surgery
• Interventions: Other: additional information via the computerized tool

• Registration Number: NCT05401617
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-20
• Study Start: 2022-05-30
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	additional information via the computerized tool	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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