Children Clinical Trial
— ALFAOfficial title:
Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction - Studying the Benefits of Digital Distractions in an Ambulatory Care Service
Verified date | February 2022 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 28, 2019 |
Est. primary completion date | September 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 10 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | University of Rennes 2 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | correlation between the flow state and preoperative anxiety | This will involve assessing the correlation between the flow state and preoperative anxiety.
The tool used is the mYPAS. It is an observation based-method. Observation grid is composed of five dimensions : activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents. The observer chooses a score for the five dimensions based on the criteria provided in the grid. The tool used is the Flow Observation Grid. It is an observation based-method. Observation gri dis composed of three dimensions : concentration, joy, frustration. The observer chooses a score for the three dimensions based on the criteria provided in the grid. |
On the day of surgery |
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