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Information and Anaesthesia in Paediatrics

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ClinicalTrials.gov Identifier: NCT00841022
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Anxiety Other: Information with comics

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
Study Start Date : February 2009
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Information of children with comic leaflet
Other: Information with comics
Information of children with comic leaflet
No Intervention: 2

Primary Outcome Measures :
  1. Level of anxiety scale (STAIC-S) [ Time Frame: before preanaesthesia consultation and after preanaesthesia consultation ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841022

Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Edmundo PEREIRA DE SOUZA NETO, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00841022     History of Changes
Other Study ID Numbers: 2008.518
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Hospices Civils de Lyon:
Elective surgery

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Central Nervous System Depressants
Physiological Effects of Drugs