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

NCT ID: NCT06227663

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2022-09-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Access to the KOALOU(®) digital application

Group Type: EXPERIMENTAL

KOALOU(®) digital application

Intervention Type: BEHAVIORAL

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

No access

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier de Valenciennes

Valenciennes, Hauts-de-France, France

Countries

France

Other Identifiers

2021-03

Identifier Type: -

Identifier Source: org_study_id