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Information and Anaesthesia in Paediatrics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00841022
Enrollment
115
Registered
2009-02-11
Start date
2009-02-28
Completion date
2013-04-30
Last updated
2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, anaesthesia, child, RCT, Elective surgery

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.

Interventions

OTHERInformation with comics

Information of children with comic leaflet

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Level of anxiety scale (STAIC-S)before preanaesthesia consultation and after preanaesthesia consultation

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026