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

NCT06227663 | Completed

• 1 other identifier: 2021-03
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Postoperative

Keywords

Preoperative anxiety; Ambulatory surgery; Pediatrics anesthesia; Digital application; Postoperative maladaptative behavioral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative maladaptative behavioral

  during the day-7 phone call

• Preoperative anxiety in the surgery department before the surgery

  in the surgery department before the surgery

• 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

• Acceptance of the mask

  At the time of the induction

• 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

Study Arms (2)

Access to the KOALOU(®) digital application

EXPERIMENTAL

Behavioral: KOALOU(®) digital application

No access

NO INTERVENTION

Interventions

KOALOU(®) digital application BEHAVIORAL

Digital app that prepares children for the ambulatory surgery care pathway by assessing their anxiety and educating them about anesthesia and surgery

Access to the KOALOU(®) digital application

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, Hauts-de-France, 59300, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: January 29, 2024
• Study Start: August 19, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 22, 2022
• Last Updated: January 29, 2024

Record last verified: 2023-11

Locations

FR (1)