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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05401617

Acronym

Anx'Appli

Enrollment

182

Registered

2022-06-02

Start date

2021-05-12

Completion date

2022-10-24

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Surgery

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

Interventions

OTHERadditional information via the computerized tool

additional information delivered via the computerized tool

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 10 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORVincent Compere

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026