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OpenTrials
Completed

NCT Number: NCT06227663

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

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.

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Key information

Conditions

Anxiety Postoperative

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Valenciennes

Valenciennes, Hauts-de-France, 59300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Preoperative anxiety in the operating room before the induction

    Time frame: 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 outcomes

  1. Postoperative maladaptative behavioral

    Time frame: 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.

  2. Preoperative anxiety in the surgery department before the surgery

    Time frame: 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.

  3. Anxiety of the parents

    Time frame: 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.

  4. Acceptance of the mask

    Time frame: 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

  5. Agitation of the child

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Registry information

Official study 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 .

Acronym: KOALOU

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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