Clinical trial NCT06227663: Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery
Official title: Impact Assessment on Anxiety of Using a KOALOU® Digital Application for Children Undergoing Scheduled Ambulatory Surgery Compared to Those Who do Not Use the Application .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Postoperative
Keywords: Preoperative anxiety
Ambulatory surgery
Pediatrics anesthesia
Digital application
Postoperative maladaptative behavioral
Lead sponsor: Centre Hospitalier de Valenciennes
Sponsor class: NETWORK
First posted: 2024-01-29
Enrollment: 98
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative anxiety in the operating room before the induction
timeFrame: in the operating room before the induction
Secondary outcomes:
measure: Postoperative maladaptative behavioral
timeFrame: during the day-7 phone call
measure: Preoperative anxiety in the surgery department before the surgery
timeFrame: in the surgery department before the surgery
measure: Anxiety of the parents
timeFrame: In our hospital the chid is going alone in the operating room. The anxiety of the parents is measured in the hospitalization room after the separation with the child when the child is going in the operative room
measure: Acceptance of the mask
timeFrame: At the time of the induction
measure: Agitation of the child
timeFrame: in the postoperative monitoring room after the operation when the child is waking up. It is measured just after the entry and just before the exit of the postoperative monitoring room
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
state: Hauts-de-France
Study officials:
References: