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Information and Anaesthesia in Paediatrics

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: February 10, 2009
Last updated: October 22, 2013
Last verified: October 2013

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 Intervention
Anxiety Other: Information with comics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

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

Secondary Outcome Measures:
  • Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension) [ Time Frame: before preanaesthesia consultation ]
  • Level of anxiety scale (STAIC-T) [ Time Frame: Before preanaesthesia consultation ]

Enrollment: 115
Study Start Date: February 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Information of children with comic leaflet
Other: Information with comics
Information of children with comic leaflet
No Intervention: 2


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Hospices Civils de Lyon Identifier: NCT00841022     History of Changes
Other Study ID Numbers: 2008.518
Study First Received: February 10, 2009
Last Updated: October 22, 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 processed this record on August 16, 2017