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

C

Centre Hospitalier de Valenciennes

Status

Completed

Conditions

Anxiety Postoperative

Treatments

Behavioral: KOALOU(®) digital application

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06227663
2021-03

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

Access to the KOALOU(®) digital application
Experimental group
Treatment:
Behavioral: KOALOU(®) digital application
No access
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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