Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery

Centre Hospitalier de Valenciennes98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety Postoperative

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Preoperative anxiety in the operating room before the induction

Compare the anxiety of children in the operating room before induction according to the use or not of the KOALOU® application. The primary endpoint is defined by the mYPAS-SF score calculated in the operating room before induction. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.

Time frame: in the operating room before the induction

Secondary Outcomes

Postoperative maladaptative behavioral

Compare the existence of postoperative maladaptative behavioral of children on day-7 depending on the use or not of the KOALOU® application using the PHBQ score. The PHBQ score is the Post Hospitalization Behavioral Questionnaire. It is going from 23 to 115. 23 means no postoperative maladaptative behaviors and 115 means maximum postoperative maladaptative behaviors.

Time frame: during the day-7 phone call

Preoperative anxiety in the surgery department before the surgery

Compare the anxiety of children in the surgery department before the surgery according to the use or not of the KOALOU® application using the mYPAS-SF score. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.

Time frame: in the surgery department before the surgery

Anxiety of the parents

Compare the anxiety of the parents according to the use or not of the KOALOU® application after the separation with the child using the STAI-YA scale. The STAI-YA scale is the State Trait Anxiety Inventory in the A form. It is going from 20 to 80. 20 is the minimal level of anxiety and 80 is the maximal level of anxiety.

Time frame: 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

Acceptance of the mask

Compare the proportion of the acceptance of the mask at the time of the induction according to the use or not of the KOALOU® application

Time frame: At the time of the induction

Agitation of the child

Compare the level of agitation of the child in the postoprative monitoring room according to the use or not of the KOALOU® application using the Watcha Scale score. It is going from 1 to 4. 1 means that the child and 4 that the child is agitated.

Time frame: 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