TerminatedNot Applicable

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

Stopped: Difficulty in enrolling new patients

France182 participantsStarted 2021-05-12

Plain-language 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

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of anxiety on entering the operating room

Timeframe: 15 days

Trial details

NCT IDNCT05401617

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-24

View on ClinicalTrials.gov More Pediatric Surgery trials

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.