Information and Anaesthesia in Paediatrics

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841022
• Other study ID #: 2008.518
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Information with comics
Information of children with comic leaflet

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & 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;11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of anxiety scale (STAIC-S)		before preanaesthesia consultation and after preanaesthesia consultation
Secondary	Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)		before preanaesthesia consultation
Secondary	Level of anxiety scale (STAIC-T)		Before preanaesthesia consultation