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Completed

NCT Number: NCT00841022

Information and Anaesthesia in Paediatrics

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Information with comics

Other

Information of children with comic leaflet

Primary outcomes

  1. Level of anxiety scale (STAIC-S)

    Time frame: before preanaesthesia consultation and after preanaesthesia consultation

Secondary outcomes

  1. Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)

    Time frame: before preanaesthesia consultation

  2. Level of anxiety scale (STAIC-T)

    Time frame: Before preanaesthesia consultation

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2009
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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