Information and Anaesthesia in Paediatrics
Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
1 other identifier
interventional
115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Feb 2009
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 28, 2019
October 1, 2013
4.2 years
February 10, 2009
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of anxiety scale (STAIC-S)
before preanaesthesia consultation and after preanaesthesia consultation
Secondary Outcomes (2)
Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
before preanaesthesia consultation
Level of anxiety scale (STAIC-T)
Before preanaesthesia consultation
Study Arms (2)
1
EXPERIMENTALInformation of children with comic leaflet
2
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous surgery.
- Unwillingness to participate (parents or child)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69002, France
Related Publications (1)
Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
PMID: 27317708RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmundo PEREIRA DE SOUZA NETO, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 28, 2019
Record last verified: 2013-10