Information and Anaesthesia in Paediatrics

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Information with comics

• Registration Number: NCT00841022
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Information with comics	Information of children with comic leaflet

Primary Outcome Measures

Name	Time	Method
Level of anxiety scale (STAIC-S)	before preanaesthesia consultation and after preanaesthesia consultation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France