Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful D… (NCT04079244) | Clinical Trial Compass
CompletedNot Applicable
Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction
France100 participantsStarted 2019-05-14
Plain-language summary
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety.
During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control.
In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital.
In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic.
In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.
Who can participate
Age range
3 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:
* Children aged 3 to 10 years
* Benefiting from an ambulatory surgery under general anesthesia
* Whose parents or the legal representative of the parental authority do not object to his participation
* Written consent of one of the parents or the legal representative of the parental authority to the video recording of the child.
Exclusion Criteria:
* Children participating in another study
* No understanding of the French language by the parents and/or the child
* Major developmental delay, psychiatric pathology or visual impairment that does not allow the children to play on a tablet.
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
correlation between the flow state and preoperative anxiety