Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery (NCT06227663) | Clinical Trial Compass
CompletedNot Applicable
Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery
France98 participantsStarted 2021-08-19
Plain-language summary
The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Pre-operative anxiety is often managed by pharmacological premedication. However, there are many alternative techniques to reduce children's anxiety before surgery.
The use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery.
First, it allows an evaluation of the pre-operative anxiety level of children via validated scales. Secondly, it provides information to the children using methods adapted to their age and level of understanding.
Thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.
Who can participate
Age range
3 Years – 12 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 :
* Patients from 3 to 12 years old.
* Outpatient hospitalization for a scheduled surgery or procedure under general anesthesia.
* Clinically stable condition.
* Information note sent to parents and collection of their consent to their child's participation in the study.
* Parental affiliation to a social security system.
Exclusion criteria :
* Urgent intervention situation.
* Patient included in another study.
* No compatible hardware for the application or no internet connection (smartphone, tablet, computer).
* Patient not affiliated to social security.
* Mental retardation or psychoactive disorders.
* Intravenous induction.
* Need for premedication.
* Patient who had general anesthesia less than one year ago and/or after the age of 3.
* Patient who had surgery less than one year ago and/or after the age of 3.
* Child's refusal.
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
1
Preoperative anxiety in the operating room before the induction
Timeframe: in the operating room before the induction