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

• 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

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