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

Anxiety Postoperative Clinical Trial

— KOALOU  

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06227663
• Other study ID #: 2021-03
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: November 2023
• Source: Centre Hospitalier de Valenciennes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 22, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Postoperative

Intervention

Behavioral:
• KOALOU(®) digital application
Digital app that prepares children for the ambulatory surgery care pathway by assessing their anxiety and educating them about anesthesia and surgery

Locations

Country	Name	City	State
France	Centre Hospitalier de Valenciennes	Valenciennes	Hauts-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valenciennes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	in the operating room before the induction
Secondary	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.	during the day-7 phone call
Secondary	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.	in the surgery department before the surgery
Secondary	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.	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
Secondary	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	At the time of the induction
Secondary	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.	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