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

Not Applicable

Completed

• Conditions: Anxiety Postoperative
• Interventions: Behavioral: KOALOU(®) digital application

• Registration Number: NCT06227663
• Lead Sponsor: Centre Hospitalier de Valenciennes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2022-08-29
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-22
• Status Verified: 2023-11
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Access to the KOALOU(®) digital application	KOALOU(®) digital application	-

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety in the operating room before the induction	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative maladaptative behavioral	during the day-7 phone call	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.
Acceptance of the mask	At the time of the induction	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
Agitation of the child	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	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.
Preoperative anxiety in the surgery department before the surgery	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.
Anxiety of the parents	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	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.

Trial Locations

Locations (1)

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, Hauts-de-France, France