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

University Hospital, Rouen

Status: Unknown

Conditions: Pediatric Surgery

Treatments: Other: additional information via the computerized tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05401617

2019/087/HP

Details and patient eligibility

About

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

Enrollment: 352 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

control group

No Intervention group

Description:

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 group

Experimental group

Description:

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.

Treatment:

Other: additional information via the computerized tool