Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

Hospices Civils de Lyon1 site in 1 country115 target enrollmentFebruary 2009

ConditionsAnxiety

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Hospices Civils de Lyon
Enrollment: 115
Locations: 1
Primary Endpoint: Level of anxiety scale (STAIC-S)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

April 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female children between 6 to 16 years and 11 month old.
•Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
•Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating).
•Children coming with their parents.

Exclusion Criteria

•Previous surgery.
•Unwillingness to participate (parents or child)

Outcomes

Primary Outcomes

Level of anxiety scale (STAIC-S)

Time Frame: before preanaesthesia consultation and after preanaesthesia consultation

Secondary Outcomes

Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)(before preanaesthesia consultation)
Level of anxiety scale (STAIC-T)(Before preanaesthesia consultation)