Clinical trial NCT04079244: Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Ambulatory Surgery
General Anesthesia
Keywords: Preoperative anxiety
Distractions
Flow
Child
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: University of Rennes 2
First posted: 2019-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
Primary purpose: OTHER

Brief 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.

Detailed description: This study takes an interest on the problem of the well-being of children during an outpatient surgery.

Children are often anxious before a surgery under general anesthetic because of unfamiliar environments, separation from parents, loss of control or uncertainty about anesthesia. 50% to 70% of children develop anxiety after surgery. Anxiety before surgery are associated with behavioral changes in postoperative like increase in anxiety, sleep or eating disturbances and with postoperative pain.

To reduce this preoperative anxiety, the use of anxiolytics (hypnovel, hydroxizyne) is the most commonly used method. But this premedication remains controversial (paradoxical effects with rebound of anxiety, loss of explicit memorization).

The aim of this study is to examine two non-pharmacological and non-invasive methods (technological distraction through video games and animated cartoons) that seem to be effective in reducing preoperative anxiety and its postoperative repercussions. Much studies show the benefits of preoperative distraction method to reduce children's anxiety, such as cartoons, video games, puzzles.

It is now necessary to understand the processes underlying the relationship between the preoperative anxiety and distraction method.

Video games and cartoons are supposed to foster a high level of cognitive engagement in children, which would allow them to focus less on the anxiogenic elements of the operating context and thus reduce their preoperative anxiety. This state of cognitive engagement is called flow. Flow is defined as a state in which person is so involved in an activity that nothing else matters.

Within the paediatric anaesthesia department of the University Hospital Rennes Sud, the playful video game "Le Héros C'est Toi" is systematically offered to children aged 3 to 10 years to accompany them throughout the course of care during outpatient surgery. This has been a standard practice since 2014.

In this project, the aim is to examine the links between the state of flow, generated by a playful application on tablet or animated cartoon, and the preoperative anxiety of children.

Protocol :

The day of the intervention surgery, the study is proposed to the parents and the children on their arrival. If the participants are in favor, the consent documents are given to them. Patient inclusion is ongoing, after verification of inclusion criteria, parental consent and signed consent. The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".

At their arrival in ambulatory care service, when child is in the room a first video recording is made in order to examine the anxiety of the child. Then tablet with the video game or animated cartoon is made available to the child. The tablet is available to the child until anesthetic induction.

Four others video recording are made :

* before the child leaves for the waiting room to examine the flow state of the child until the separation with the parents to examine the anxiety of the child,
* when the child is in the waiting room to examine the flow state of the child
* and during the anesthetic induction to examine the anxiety of the child.

While the children are in the operating room, parents must complete questionnaires to evaluate anxiety-trait of the children and anxiety-state of the parent.

The pain's score and the emergence delirium of the child on waking are recorded.

The day after the intervention, a call is made to parents to examine the postoperative behavioral changes of the children. Two other calls are made a week after and a month after.

Materials:

To examine the anxiety-state of the child on video recording the investigators use an observational grid, the mYPAS To examine the anxiety-trait of the child the investigators use the questionnaire PAS-R To examine the anxiety-state of the parents the investigators use the questionnaire STAI-S To examine the pain of the child on waking the investigatorsuse an observational grid FLACC To examine the emergence delirium of the child on waking the investigators use an observational grid, the EPAD To examine the flow state on video recording of the child, the investigatorsuse an observational grid. This tool is currently psychometrically tested.

To examine the postoperative behavioral change, the investigators use the questionnaire PHBQ

Eligibility criteria: 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.

Primary outcomes:
measure: correlation between the flow state and preoperative anxiety
timeFrame: On the day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Eric Wodey, PH-PD
role: PRINCIPAL_INVESTIGATOR
References: